Characteristics of Included Studies

MethodsParticipantsOutcomesInterventionsNotes
ANCARANI1993
Study Type: RCT

Study Description: 1/42 treatment, 1/11 placebo withdrawn, no reason given

Type of Analysis: completers*

Blindness: Double blind

Duration (days): Mean 21

Setting: 5 neurology units, ITALY

Notes: no info on randomisation

Info on Screening Process: 53 enrolled, no more info.
n= 53

Age: Mean 55

Sex: 30 males 23 females

Diagnosis: Exclusions: on dialysis for less than 4 months

Notes: undergoing dialysis 3 times per week

Baseline: IPAT DS: 36.24 (1.67) SAMe 36.20 (3.41) placebo
HARD: 25.73 (1.11) SAMe, 20.66 (2.14) placebo
Data Used
  • IPAT-DS
  • HARD
Notes: TAKEN AT: day 0 (start), day 10, day 21 (end).
DROP OUT: 1 participant from each group (2.38 SAMe, 9.09 placebo)
Group 1 N= 41
  • SAMe (S-adenosyl-L-methionine). Mean dose 400mg - SAMe (400mg) intravenously delivered on alteranate days, at the end of dialysis session.
Group 2 N= 10
  • Placebo - no info on placebo
funding: BioResearch, BASF group, Milan, Italy.
Results from this paper:
Quality assessment = +
ANDERSEN1980
Study Type: RCT

Type of Analysis: Completer only

Blindness: Double blind

Duration (days):

Setting: Denmark

Notes: RANDOMISATION: procedure not reported
n= 22

Age: Mean 59

Sex: no information

Diagnosis: Exclusions:
-

other somatic diseases

-

dementia

Baseline: Not reported
Data Not Used Notes: depression data not usable as in medians not in meansGroup 1 N= 10 Group 2 N= 12
  • Placebo
Results from this paper:
Quality assessment score = +
ANDERSEN1994
Study Type: RCT

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 42

Setting: Denmark, patients with acute stroke admitted to hospital

Notes: RANDOMISATION: no further details
n= 66

Age: Mean 67

Sex: 26 males 40 females

Diagnosis: Exclusions:
-

subarachoid hemorrhage or Binswanger's disease

-

previous degenerative or expansive neurological diseases

-

psychiatric illness other than depression

Baseline: HDRS: Citalopram 19.4 (3.1) Placebo 18.9 (2.8)
Data Used
  • Response (>50 reduction from baseline)
  • HDRS-17
Notes: TAKEN AT: Baseline and endpoint
Dropouts: Citalopram 7/33 Placebo 2/33
Group 1 N= 33 Group 2 N= 33
  • Placebo
Funding: Lundbeck Foundation, Medical Research Foundation for North Jutland, the Aalborg Diocese Research Foundation
Results from this paper:
Quality assessment score = +
ANTONINI2006
Study Type: RCT

Type of Analysis: completer only

Blindness: Single blind

Duration (days): Mean 84

Setting: Italy

Notes: no further details on randomisation
n= 31

Age: Mean 70

Sex: 14 males 17 females

Diagnosis: Exclusions:
-

severe motor fluctuations

-

psychosis

-

dementia

Baseline: HDRS: Sertraline 20.3 (3.9) Amitriptyline 19.7 (2.8)
Data Used
  • Remission (below cut-off)
  • Response (>50 reduction from baseline)
  • Physical health outcomes
  • HDRS
Notes: TAKEN AT: Baseline and endpoint
Dropouts: 4/16 Sertraline Amitriptyline 4/15
Group 1 N= 12 Group 2 N= 11 Funding: Pfizer
Results from this paper:
Quality assessment score = +
BARONE2006
Study Type: RCT

Study Description: ITT defined as all randomised participants who received at least one dose of trial medication and had at least one post baseline assessment

Type of Analysis: ITT

Blindness: Single blind

Duration (days): Mean 84

Setting: Italy

Notes: no further details on randomisation
n= 67

Age: Mean 66

Sex: 35 males 32 females

Diagnosis: Exclusions:
-

HDRS <16

-

Not on stable treatment for parkinson's

-

history of motor fluctuations

-

use of dopamine agonists, antipsychotics

-

psychosis

-

suicide attempts

Baseline: HDRS: Sertraline 21.33 (4.4) Pramipexole 19.7 (3.5)
Data Used
  • Remission (below cut-off)
  • Response (>50 reduction from baseline)
  • HDRS
Notes: TAKEN AT: Baseline and endpoint
Dropouts: Pramipexole 1/33 Sertraline 7/34
Group 1 N= 33 Group 2 N= 34 Funding: no information
Results from this paper:
Quality assessment score = +
BIRD2000
Study Type: RCT

Study Description: ITT: LOCF

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 56

Setting: 34 centres throughout UK, Ireland, Germany, Italy and Belgium.

Notes: RANDOMISATION: procedure not reported

Info on Screening Process: 210 entered, 191 randomised, 3 more dropped out from Amitriptyline group for lack of does efficacy and lack of good clinical practice.
n= 191

Age: Mean 54

Sex: 48 males 140 females

Diagnosis: Exclusions: faillure to make ICD-10 criteria for depression (mild, moderate or severe)
Risk of suicide
patients receiving MAOIs, lithium, ECT, an SSRI, tricyclic or tetracyclic antidepressant 8 weeks from the trial start.
Patients with severe co-existing illness that may be effected by the study medications

Notes: all participants had history of arthritis for over 1 year.
Previous episodes of major depression: (19.1) paroxetine group and (17.0) in amitriptyline. Previous history
ofanxiety/obsessional disorders: (8.5) paroxetine group and (7.4) in amitriptyline.

Baseline: MADRS total: 24.4 (5.1) Paroxetine, 24.3 (5.5) Amitriptyline
Data Used
  • PGE
  • Physical health outcomes (self-report)
  • CGI-I
  • Adverse events
  • MADRS
Notes: TAKEN AT: Baseline,weeks 4, 8 and end of treatment
DROP OUT: 18(19.1) Paroxetine, 19 (20.2) amitriptyline
Leaving due to adverse events: 15 (16.0) paroxetine, 14 (14.9) amitriptyline
Group 1 N= 94
  • Paroxetine. Mean dose 20-40mg - Start dose: 20mg for 2 weeks. After this could increase to 40mg if required.
  • Also received an amitriptyline matched placebo.
Group 2 N= 94
  • Amitriptyline. Mean dose 75-150mg - Start dose: 75mg for 2 weeks. After this could increase to 150mg if required.
  • Also received a paroxetine matched placebo.
educational grant from SmithKline Beecham
Results from this paper:
Quality assessment result: +
BLUMENFIELD1997
Study Type: RCT

Study Description: * 1/7 treatment left study, all placebo participants completed

Type of Analysis: completers*

Blindness: Double blind

Duration (days): Mean 56

Setting: 2 hospitals, New York, US.

Notes: Details on randomisation not reported.

Info on Screening Process: no info
n= 14

Age:

Sex: no information

Diagnosis: Exclusions:
-

not between 18-70 years of age

-

other chronic illness

-

other psychiatric disorder other that major depressive disorder

-

received psychotropic medication in the week prior to study

-

received MAOIs two weeks prior to service

-

not satisfy the criteria for major depressive disorder

-

pregnant or woman of child bearing age not using contraception

-

involved in any other drug study prior to this study

Notes: all subjects on dialysis

Baseline: not stated, although all participants scored at least 16 on the HADS.
Data Used
  • HADS
  • BDI
Notes: TAKEN AT:
DROP OUT:
Group 1 N= 6 Group 2 N= 7
  • Placebo - placebo as capsule
Funded by the Lily Research Laboratory.
Results from this paper:
Quality assessment = +
BORSON1992
Study Type: RCT

Type of Analysis: Completer

Blindness: Double blind

Duration (days): Mean 84

Setting: VA medical centres and private practices
SEATTLE, US

Notes: RANDOMISATION: Assignment to treatment was conducted by a psychiatrist blind to the study questions using a random number table

Info on Screening Process: Not reported
n= 36

Age: Mean 61

Sex: 22 males 14 females

Diagnosis:
  • 100% COPD by Not specified
  • 100% Depression by DSM-III
Exclusions:
-

Primary diagnosis not moderate to severe COPD

-

No diagnosis of depression

-

Another medical illness more disabling than lung disease

-

MMSE <25 indicating severe cognitive impairment

-

Recent stroke ot myocardial infarction

-

Currently abusing alcohol

-

If other psychotropics couldnɹt be withdrawn

-

Taking <40mg of prednisone daily and those who began home oxygen treatment within the month

Notes: All participants were outpatients with 39% receiving care from VA physicians and 61% from community providers.

Baseline: HAM-D: 29.6(7.6) Nortriptyline; 29.5(6.4) placebo
Data Used
  • Functional Index of Living
  • CGI-I
  • Physical health outcomes
  • Adverse events
  • HAM-D
  • Response (based on CGI)
Notes: TAKEN AT: baseline and end of treatment
DROPOUT: Nortrip: 5/18; Placebo: 1/18 Leavinf due to adverse events
Group 1 N= 18
  • Nortriptyline. Mean dose 67.3 -Antidepressant treatment was initiated at one-forth the final calculated dose of 1mg/kg body weight
Group 2 N= 18
  • Placebo - Identical placebo to maintain blinding
Non-drug company funded (medical research service) but drug compies supplied both the active treatment and placebo treatment
Results from this paper:
Quality assessment: +
BROWN2005A
Study Type: RCT

Study Description: * Analysis includedl those who completed baseline + <= one post-baseline evaluation regardless of study completion LOCF used for missing data

Type of Analysis: ITT*

Blindness: Double blind

Duration (days): Mean 84

Setting: Astham Clinic
DALLAS, US

Notes: RANDOMISATION: procedure not reported

Info on Screening Process: Not reported
n= 90

Age: Mean 41

Sex: 16 males 66 females

Diagnosis: Exclusions:
-

Unable to speak English or Spanish

-

No physician diagnosis of asthma and not currently taking asthma medication

-

<17 on HAM-D

-

Current substance abuse

-

Psychosis

-

High suicide risk

-

Clinically significant hypothyroidism

-

Severe cognitive impairment

-

Pregnant/ nursing women

-

Prison or jail inmates

-

prior treatment with citalopram or a history of lifetime treatment resistant depression defined as no adequate response to two trials of antidepressants

Notes: Participants were identified through a two item screening tool but required a diagnosis of MDD

Baseline: HAMD 24.0 citalopram; 23.4 placebo
Data Used
  • IDS-SR
  • Adverse events
  • AQLQ
  • ACQ
  • HAM-D
  • Remission (below cut-off)
  • Response (>50 reduction from baseline)
Notes: TAKEN AT: Baseline, wks, 1-12, End of treatment
DROPOUT: 23/41 Citalopram; 16/41 placebo (based on the 82 evaluable sample)
Group 1 N= 41 Group 2 N= 41
  • Placebo
Although 90 participants were randomisted, the paper only presents and analyses data from 83 participants
Results from this paper:
Quality assessment score = +
CHEN2002
Study Type: RCT

Type of Analysis: completer only

Blindness: No mention

Duration (days): Mean 56

Setting: China,

Notes: RANDOMISATION: no further details
n= 60

Age:

Sex: no information

Diagnosis: Exclusions:
-

prestroke psychiatric illness

-

cognitive impairment

-

suicidal ideation

Baseline: HAMD: Paroxetine 20.2 (3.3) Doxepin 19.2 (1.9) Placebo 18.1 (3.1)
Data Used
  • ADL
  • HDRS-17
Notes: TAKEN AT: Baseline and endpoint
Dropouts: Paroxetine 0/24 Doxepine 8/16 (all AEs) Placebo 4/20 (lack of efficacy)
Group 1 N= 24 Group 2 N= 20
  • Placebo. Mean dose 30mg/d - Guvitamine
Group 3 N= 16
  • Doxepine. Mean dose 25mg/d
no information on funding
Results from this paper:
Quality assessment score = +
COSTA1985
Study Type: RCT

Study Description: Efficacy assessments were based on LOCF in which missing scores from patients who dropped out before day 21 had ther ast observation score assigned.

Type of Analysis: ITT and completer

Blindness: Double blind

Duration (days): Mean 28

Setting: In-patient (70/73 participants)

Notes: RANDOMISATION: procedure not reported

Info on Screening Process: Not stated
n= 73

Age: Mean 52

Sex: all females

Diagnosis: Exclusions:
-

age <18

-

no diagnosis of depression accorind to criteria proposed by Stewart et al and Kathol & Perry

-

Depression not succeeding or paralleling development of cancer

-

Zung self-rating score <41, Ham-D <16

-

diagnoses of alcoholism, drug use disorder, personality disorder, schizoaffective disorder, depressive symdrome superimposed on residual schizophrenia, organic mental disorder

-

epilepsy

-

Vomiting resistant to treatment

Notes: Stages II III and IV included. Cancers localisations included breat, overay, uterine cervix and other.
Depression diagnosis based on screening and then psychiatric evaluation based on Kathhol & Petty criteria for depression in medically ill patients.

Baseline: Zung: Mianserin 50.1(6.31) Placebo 51.2(6.56)
CGI: Mianserin 3.33(1.19) Placebo 3.32(1.09)
HAMD: Mianserin 20.6(3.62) Placbo 20.8(3.85)
Data Used
  • Adverse events
  • HDRS-17
  • CGI-S
  • Brief Zung Self-rating Depression Scale
Notes: TAKEN AT: Baseline and and of treatment DROPOUT: Mianserin 7/36 (19%) placebo 15/37 (41%)
Leaving the study early due to side effects: Mianserin 1/36 Placebo 1/37
Group 1 N= 36
  • Mianserin. Mean dose 44.5mg/day - 10mg Mianserin tablets. During week 1, 1 tablet t.i.d., following 3 weeks 2 tablets t.i.d.
  • Dose could be modified according to therapeutic effect and tolerance.
Group 2 N= 37
  • Placebo
Funding not mentioned
Results from this paper:
Quality assessment score = +
DEVOS2008
Study Type: RCT

Study Description: All participants were included in the analysis for primary data
Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 30

Setting: France, LILLE

Notes: RANDOMISATION: Independently stratified using a randomisation table. List was transmitted to an independent contract research organisation for prepara

Info on Screening Process: 48 participants screened, no screening failures
n= 48

Age: Mean 62

Sex: 15 males 27 females

Diagnosis: Exclusions:
-

>80 years

-

Parkinson's Disease <2 years

-

not receiving optimal dose of dopaminergic treatment

-

not meeting DSM-IV criteria for major depression

-

<20 MADRS

-

serious or unstable medical condition

-

Dementia

-

psychotic disorders and suicidal thoughts

Baseline: No significant differences at baseline between groups: MADRS: placebo 27, Citalopram 25, Despiramine 29
Reports demongraphic data for 42/48 participants
Data Used
  • MADRS
  • Response (>50 reduction from baseline)
  • Remission (below cut-off)
Notes: TAKEN AT: Baseline and 30 days (end of treatment)
DROP OUT: Placebo 0/16, Citalopram 2/15, Desipramine 1/17
Group 1 N= 16
  • Placebo - Three placebo tablets
Group 2 N= 15
  • Citalopram. Mean dose 20mg/day - Citalopram treatment consisted of one 20mg tablet and two placebo tablets
Group 3 N= 17
  • Desipramine. Mean dose 75mg/day - Desipramine treatment consisted of two 25mg tablets and 1 placebo tablet for 2 days followed by three 25mg tabletsfor last 28 days
Non-drug company funded (funded by French Ministry of Health grant
Results from this paper:
Quality assessment score ++
EHDE2008
Study Type: RCT

Study Description: All outcomes analysed using ITT regardless of participant's adherence to protocol. For the main analyses, baseline values were substituted for missing

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 84

Setting: WASHINGTON, US
-

participants wer erecruited from various centres and clinics

Notes: RANDOMISATION: a randomisation table was prepared in blocks of 10 using a computerised random number generator.

Info on Screening Process: 349 participants assessed for eligibility, 215 were excluded (main reason due to taking antidepressants) and 90 people declined
n= 42

Age: Mean 45 Range 24-63

Sex: 20 males 22 females

Diagnosis: Exclusions:
-

Age <18years

-

Diagnosis of MS not confirmed by neurologist or MS-specialising physiatrist

-

No diagnosis of MDD or dysthymia based on DSM-IV criteria

-

Failed paroxetine treatment in past

-

Receiving psychotherapy

-

Taking psychopsychotropic medications

-

Taking >50mg/day amitriptyline or equivalent for pain or sleep

-

suicidal ideation necessitating immediate psychiatric intervention

-

pregnant, nursing or not using adequate contraception

-

participating in another drug study

-

use of corticosteroids within 2 weeks prior to enrollment

Notes: Participants scoring >=16 on the CES-D at screening were questioned regarding inclusion/exclusion criteria. Those meeting inclusion criteria attended an interview with a psychiatrist.

Baseline: No significant differences at baseline
HAM-D: 17.2(4.3)prx, 19.0(4.6) placbo
CES-D: 33.3(9.3) Prx, 35.9(8.3) Placebo
Data Used
  • Adverse events
  • MS QoL scale
  • SWLS
  • SCL 20
  • SCL 90
  • CES-D
  • HAM-A
  • HAM-D
  • Response (>50 reduction from baseline)
  • Remission (below cut-off)
Notes: TAKEN AT: baseline, 6 weeks (mid treatment), 12 weeks (post treatment)
DROPOUT: Prx: 4/22 (18%) Placebo: 1/20 (5%) Leaving the study early due to adverse events: Prx2/22, placebo 0/20
Group 1 N= 22
  • Paroxetine. Mean dose 10-40mg/day - Initial dose 10mgday (one capsule) for one week. Doseage increased to 20mg/day if tolerated. On each visit the psychiatrist adjusted the study medication up to 4 capsule s(40mg/day) depending on clinical outcome and side effects
Group 2 N= 20
  • Placebo - up to 4 capsules of placebo could be given
Study supported by non-industry grant. Drugs provided by GlaxoSmithKline
Results from this paper:
Quality assessed: +
EISER2005
Study Type: RCT

Study Description: 6 week double-blind placebo controlled study followed by a 3 month open-label extension period

Type of Analysis: Completer

Blindness: Double blind

Duration (days): Mean 42

Setting: Lewisham, UK

Notes: RANDOMISATION: procedure not reported

Info on Screening Process: 135 people were screened, 47 screened positive for depression of which 28 received a diagnosis and areed to participate
n= 28

Age: Mean 66 Range 49-79

Sex: 14 males 14 females

Diagnosis:
  • 100% COPD by Current diagnosis
  • 100% Depression by ICD-10
Exclusions:
-

No diagnosis of COPD and/or a change in FEV after bronchodilators of >15% of normal values

-

no history of smoking (either current or past)

-

Excerise tolerance not affected by COPD

-

No diagnosis of clinical depression

-

Previously diagnosis with dperession

-

Use of psychotrophic drugs within past 3 months

-

signifiacnt co-morbidity limiting mobility e.g. cardiothoracic

Notes: All had a diagnosis of moderate to severe COPD

Baseline: HAD 12(3); BDI 23(8)
Data Used
  • SGRQ
  • MADRS
  • Physical health outcomes
  • BDI
  • HADS
Notes: TAKEN AT: baseline and end point (end of double-blind stage)
DROPOUT: 4/14 Prx; 0/14 Placebo
Group 1 N= 14 Group 2 N= 14
  • Placebo
Funding not reported
Results from this paper:
Quality Assessment score: +
EVANS1997
Study Type: RCT

Study Description: ITT included all those who completed at least 3 weeks of treatment. Discontinuations prior to 3 weeks were excluded from the analysis.

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 56

Setting: UK, LIVERPOOL

Notes: RANDOMISATION: procedure not reported

Info on Screening Process: 144 patients were diagnosed with depression, 58 wer enot included int eh trial due to refusal, physician's decision, medical contraindication, and other reasons
n= 82

Age: Mean 82

Sex: 14 males 59 females

Diagnosis: Exclusions:
-

<65 years old

-

Suicidal intent or severe depression requiring ECT

-

serious mental illness

-

Already receiving psychotropic medication other than hypnotics

-

unstable epilepsy

-

severe cognitive impairment (MMSE <10)

Notes: Participants had various medical illnesses. A sub-group analysis of those with serious illnesses was conducted in a follow-up paper

Baseline: Only reported for 76/82.
No baseline differences HAMD Flx 20.5, Placebo 21.0
Data Used
  • Adverse events
  • Response (>50 reduction from baseline)
Notes: TAKEN AT: Baseline and 8 weeks (end of treatment)
DROP OUT: Flx: 18/39 Placebo 23/43
Group 1 N= 39
  • Fluoxetine. Mean dose 20mg/day - 20mg/day given in the morning for 8 weeks
Group 2 N= 43
  • Placebo
Drug-company sponsored (Lilly Industries Ltd)
Results from this paper:
Quality assessment score +
FISCH2003
Study Type: RCT

Study Description: * ITT- all participants with at least one follow-up were assessable for the primary outcome.Generalised estimating equation used for missing data.

Type of Analysis: ITT and completers*

Blindness: Double blind

Duration (days): Mean 84

Setting: 15 sites of the Hoosier Oncology group, US (3 academic centres, 12 community sites)

Notes: RANDOMISATION: Patients were stratified on the basis of Eastern Cooperative Oncology Group performance. The randomisation was performed centrally.

Info on Screening Process: Not reported
n= 163

Age: Mean 60

Sex: 82 males 81 females

Diagnosis: Exclusions:
-

Scoring <2 on a two-item screening survey for depression and anhedonia

-

Serious suicidal risk or psychotic behaviours

-

Inabililty to swallow oral medications

-

Regular use of antidepressants or psychotropic drugs (other than phenothiazine-type antiemetics or benzodiazepines) within 6 weeks of the baseline study evaluation

-

Uncontrolled brain or leptomeningeal disease

-

current use of MAOIs

-

Enrollment onto another clinical trial with QOL as the primary outcome

-

Recent or active substance abuse

-

Major depression as diagnosed by a psychiatrist

Baseline: Brief Zung Self-rating Depression Scale: Fluoxetine 24.44 (6.56) Placebo 23.09 (5.91
FACT-G: Fluoxetine 64.30 (15.80) Placebo 67.40 (16.26)
Data Used Notes: TAKEN AT 3-6 weeks into treatment DROP OUT Fluoxetine 19/83, Placebo 15/80
Discontinued study drug due to adverse events: Fluoxetine 4/83 Placebo 2/80
Group 1 N= 83
  • Fluoxetine. Mean dose 20mg - The study drug was self-administerd by the patient once daily in the morning
Group 2 N= 80
  • Placebo - Patients received an identical placebo tablet which wa self-administered once daily in the morning
Supported in part by Mary Margaret Walther program for Cancer Care Research.
Fluoxetine, placebo and study notebooks provided by Eli Lilly
Results from this paper:
Quality assessment score = +
FRUEHWALD2003
Study Type: RCT

Type of Analysis: completer only

Blindness: Double blind

Duration (days): Mean 90

Followup: 3 months then open label follow up

Setting: France, neurorehabilitation unit

Notes: RANDOMISATION: generated by computer programme independently of the research team
n= 54

Age: Mean 64

Sex: 21 males 29 females

Diagnosis: Exclusions:
-

HDS <15

-

more than mild communication deficits and/or cognitive impairment

-

relevant diseases of the CNS

-

previous degenerative or expansive neurological disorders

Baseline: HDS: Fluoxetine 32.8(12.7) Placebo 30.3(15)
BDI: Fluoxetine 12.2 (5.6) Placebo 10.9(5.4)
Data Used
  • MMSE
  • HDRS
  • BDI
Notes: TAKEN AT: Baseline and endpoint
Dropouts: Fluoxetine 2/28 Placebo 2/26
Group 1 N= 28 Group 2 N= 26
  • Placebo
Drug company sponsored:
Lannacher Heilmittel
Results from this paper:
Quality assessment score = +
GLASSMAN2002
Study Type: RCT

Study Description: Intention to treat

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 168

Setting: Outpatient cardiology and psychiatry clinics US, Canada, Europe, Australia

Notes: RANDOMISATION: no description

Info on Screening Process: 11546 screened, 8191 did not have MI or angina, 2799 did not have depression, 187 did not meet DSM criteria
n= 369

Age: Mean 57

Sex: 234 males 135 females

Diagnosis: Exclusions:
-

uncontrolled hypertension

-

cardiac surgery in next 6 months

-

renal dysfunction

-

substance abuse

-

psychosis, bipolar, dementia

Baseline: HAMD = 19.6
Data Used
  • Cardiovascular outcomes
  • HDRS-17
Notes: Dropouts: Sertraline 53/186 Placebo 46/183
Deaths:Sertraline 2/186 Placebo 5/183
Adverse events:Sertraline 16/186 Placebo 11/18
Group 1 N= 186
  • Sertraline. Mean dose 50-200mg - Flexible dosing: Received 50mg/d first 6 weeks, depending on response could be increased to 100mg/d at end of 6 weeks, and max 200mg/d at end of week 12.
Group 2 N= 183
  • Placebo
Drug company sponsored (Pfizer)
Participants could be removed from study at psychiatrist discretion if failed to improve Severe depression according to APA criteria
Results from this paper:
Quality assessment score = +
GOTTLIEB2007
Study Type: RCT

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 84

Setting: Heart Failure Clinic Veterans Affairs, US

Notes: RANDOMISATION: no details
n= 28

Age: Mean 62

Sex: 24 males 4 females

Diagnosis: Exclusions:
-

MI within 1 month

-

unstable angina

-

BDI <10

-

substance abuse

-

psychosis

Baseline: BDI median = 21.5
Data Used
  • SF-36
  • Remission (below cut-off)
Notes: Dropouts: Paroxetine 1/14 Placebo 1/14
Death: Paroxetine 1/14 Placebo 0/14
Group 1 N= 14
  • Paroxetine - Controlled release: started at 12.5mg/d, if tolerated well increased to 25mg/d after 2 weeks
Group 2 N= 14
  • Placebo
Drug company sponsored (GSK) Moderate depression according to APA criteria
Results from this paper:
Quality assessment score = +
GULSEREN2005
Study Type: RCT

Study Description: There is no mention of blinding of the participants, raters were however blinded.

Type of Analysis: Completer

Blindness: Rater only blind

Duration (days): Mean 84

Setting: Paitents were all outpatients being monitored at the endocrinology unit at a local hospital
TURKEY, Izmir

Notes: RANDOMISATION: details not reported

Info on Screening Process: 25 people meet the inclusion criteria but two were excluded prior to randomisation as they reported that they could not be present for regular follow ups
n= 23

Age: Mean 57

Sex: 3 males 17 females

Diagnosis: Exclusions:
-

HAM-D score <16

-

Active suicidal ideation

-

History of any psychotic disorder

-

A physical disease or mental incapacity that would prevent them from performing an interview

-

currently taking psychoactive ,edications

Notes: Type II diabetes

Baseline: HAM-D: Flx 17.5(2.4) Prx 18.8(3.0)
HAM-A: Flx 15.7(6.9) Prx 17.2(7.2)
Data Used
  • Adverse events
  • Physical health outcomes
  • Response (>50 reduction from baseline)
  • CGI-I
  • HAM-A
  • HAM-D
Data Not Used
  • SF-36 - Individual scales provided without total score
Notes: TAKEN AT: BASELINE AND END OF TREATMENT (wk12)
DROP OUT: flx 1/12 Prx 2/11
Group 1 N= 12 Group 2 N= 11 Only completer data has been used for baseline and demographic variables
Results from this paper:
Quality assessment = +
HOLLAND1998
Study Type: RCT

Study Description: ITT - LOCF for all participants who received at least one dose of study drug

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 42

Setting: Six investigation sites New York, US

Notes: RANDOMISATION: Not reported

Info on Screening Process: 2 patients withdrew before reciving active drug and one randomised patient discontinued without starting the drug.
n= 38

Age: Mean 50

Sex: all females

Diagnosis: Exclusions:
-

Male

-

Not having a diagnosis of breast carcinoma stages II, II or IV

-

Mood-congruent or mood-incongruent delusions

-

Serious suicide risk

-

Unspecified organic mental disorders or substance abuse disorders during the previous year

-

Schizophrenia or schizoaffective, paranoid or bipolar disorders

-

Taking MAOIs within 14dyad or heterocyclic antidepressants within 7 days, routine use of psychoactive drugs including benzodiazepines and lithium

-

Fluoxetine use within 30 days of initial evaluation

-

Contraindications to the use of desipramine

-

Serious medical illness

-

Allergy to study drug

Concomitant use of various drugs including tryptophan and cimetidine

-

pregnant or lactating women and women not using contraception

Baseline: HAMD: Fluoxetine 23.58, Placebo 22.79
HAMA: Fluoxetine 20.00, Placebo 19.79
CGI-S: Fluoxetine 4.84, Placebo 4.29
Data Not Used
  • HAM-D - no data
  • CGI-S - no data
  • HAM-A - no data
Notes: TAKEN AT: Baseline and post-treatment (visit 8)
DROP OUT: Fluoxetine: 6/21, Despiramine 7/17
Leaving due to adverse events: Fluoxetine 6/21 Desipramine 5/17
Group 1 N= 21
  • Fluoxetine. Mean dose 20-60mg - Fluoxetine-treated patients received 20mg of active drug in the morning and placebo in the evening 20mg/d week1-4, could increase by 20mg/week during days 29-42. Dose reduction was allowed for those patients unable to tolerate >20mg/day.
Group 2 N= 17
  • Desipramine. Mean dose 100-150mg - received 25mg active drug in the evening and placebo in the morning
  • Dose titrated in25mg/week increments to 100mg/day at wk4. Dose could be further increased by 25mg/week up to max 150mg/day. Dose reduction allowed for those unable to tolerate >100mg/d
Drug company sponsored: Eli Lilly
Results from this paper:
Quality assessment score = +
HUANG2005
Study Type: RCT

Study Description: *No dropout during study

Type of Analysis: completer only*

Blindness: No mention

Duration (days): Mean 72

Setting: Cardiology department, CHINA

Notes: RANDOMISATION: procedure not reported

Info on Screening Process: Not reported
n= 60

Age:

Sex: no information

Diagnosis: Exclusions:
-

No diagnosis of depression according to CCMD

-

Onset of depression did not follow cardiovascular or cerebrovascular disease

-

aged >70

-

history of drug allergy

-

consciousness disorders or obvious signs of dementia

-

Severe impairment in cardiac function, hepatic function or renal function

-

severe mental disorders

-

trauma, tumor, inflammation or demyelination of the brain

Notes: Participants all had vascular depression which consisted of depression following either cardiovascular or cerebrovascular events.

Baseline: There were no significant differences in age, sex or severity of depression at baseline.
HAMD Flx; 21.30 Clomipramine: 20.09
Data Used
  • HAM-D
Data Not Used
  • Response (>50 reduction from baseline) - Not meeting definition
Notes: TAKEN AT: Baseline and endpoint
DROPOUT: no drop outs during the 12 week study period
Group 1 N= 30 Group 2 N= 30
  • Clomipramine - Dose started at 25mg ×3 per day and was increasd to 50-250 3 times daily based on response and tolerability
No information about funding
Results from this paper:
Quality assessment score = +
KIMURA2000
Study Type: RCT

Type of Analysis: completer only

Blindness: Double blind

Duration (days): Mean 84

Setting: US, hospitals in Iowa and Baltimore

Notes: RANDOMISATION: no further details
n= 47

Age: Mean 60

Sex: 27 males 20 females

Diagnosis: Exclusions:
-

aphasia, dementia, decreased levels of consciousness

-

HAMD <10

Data Used
  • MMSE
  • HAM-D
Notes: TAKEN AT: Baseline and endpoint
dropouts: 12/47 not reported for each group
Group 1 N= 21
  • Nortriptyline - Iowa: 20 mg/d first week, 50mg/d for weeks 2-3, 75 mg/d weeks 4-6, 100mg from 7-12weeks
  • Baltimore: 20mg/d first week, 50mg/d for weeks 2-3, 70mg/d week 4, 100mg from 5-6 weeks
Group 2 N= 26
  • Placebo
funding: grant from NIMH and Nippon Medical School
Results from this paper:
Quality assessment score = +
LACASSE2004
Study Type: RCT

Study Description: Worst possible score was substituted for those dropping out of intervention group with the best score substituted for those dropping out of placebo

Type of Analysis: ITT and Completer

Blindness: Double blind

Duration (days): Mean 84

Setting: Respiratory care home service QUEBEC, Canada

Notes: RANDOMISATION: random number table used to allocate patients. Process under the responsibility of one hospital pharmacist not involved in trial

Info on Screening Process: 342 assessed for eligibility, 237 ineligible, 82 refused.
n= 23

Age: Mean 70

Sex: 10 males 13 females

Diagnosis:
  • 100% COPD by Clinical judgement
  • 100% Depression by GDS
Exclusions:
-

Aged <60

-

Inpatients

-

No diagnosis of COPD supported by a history of past or current smoking

-

FEV1>50% of predicted value

-

No signifiacnt depression symptoms at baseline

-

Unable to give informed consent

-

Contraindication to antidepressant therapy

-

Known hypersensitivity to actie drug or MAOI use in past 2 weeks

-

Current participation in rehabilitation programme

Notes: All participants were on long-term oxygen therapy (>=18 ours per day)

Baseline: GDS: 18.7(3.6) Prx, 17.9(5.2) Placebo
Data Used
  • Adverse events
Data Not Used
  • GDS - No usable data
  • Chronic Respiratory Questionnaire - No usabl data
Notes: TAKEN AT: Baseline and week12 (post treatment)
DROPOUT: 4/12 prx, 4/11 placebo
Group 1 N= 12
  • Paroxetine. Mean dose 5-20mg/day - Treatment started at 5mg/day with weekly 5mg increments up to 20mg/day
Group 2 N= 11
  • Placebo
Non-industry support (Quebec Lung Association). Drugs spullied by GlaxoSmithKline Trial was stopped prematurely due to problems in patient accural
Results from this paper:
Quality assessed: = +
LAKSHMANAN1986
Study Type: RCT

Type of Analysis: completer only

Blindness: Double blind

Duration (days): Mean 90

Setting: US, general medical ward (4 general medical hospitals)

Notes: RANDOMISATION: code generated in pharmacy department and not broekn until enrollment into the study had finished.

Info on Screening Process: 116 participants were screened, 74 were eligible for participation
n= 29

Age: Mean 76

Sex:

Diagnosis: Exclusions:
-

suicidal thoughts

-

glaucoma

-

cardiac disease

-

poorly controlled seizures

-

severe pulmonary or renal disease

-

aphasia

-

MMSE <20

Notes: Used HAMD

Baseline: HAMD: Doxepin 31.5 (11.0) Placebo 29.3 (7.8)
Data Used
  • Response (>50 reduction from baseline)
  • HAM-D
  • GDS
Data Not Used
  • Physical health outcomes - Not a valid scale
Notes: TAKEN AT: Baseline and endpoint
DROPOUT: 5 participants in total dropped out of the study (no info about group)
Group 1 N= 11
  • Doxepine - 10mg for people <70kg in weight and 20mg >70kg
Group 2 N= 13
  • Placebo
No information on study funding
Results from this paper:
Quality assessment score = +
LEENTJENS2003
Study Type: RCT

Study Description: All participants completed the study

Type of Analysis: Completer

Blindness: Double blind

Duration (days): Mean 67

Setting: Netherlands

Notes: no further details on randomisatin
n= 12

Age: Mean 67

Sex: 8 males 4 females

Diagnosis: Exclusions:
-

No diagnosis of Parkinson's disease

-

Not meeting DSM-IV criteria for depression

Baseline: Not reported
Data Used Notes: TAKEN AT: Baseline and endpoint No dropoutsGroup 1 N= 6
  • Sertraline - Starting dose 25mg, 50mg after 1 week, doubled to 100mg if no response at 6 weeks
Group 2 N= 6
  • Placebo
problems recruiting participants aimed for 40, trial was terminated due to problems with recruitment
Results from this paper:
Quality assessment score = +
LESPERANCE2007
Study Type: RCT

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 84

Setting: CANADA 9 academic centres Outpatient

Notes: RANDOMISATION: computer generated and concealed in opaque envelopes

Info on Screening Process: 370 screened, 30 did not have depression, 30 HAMD <20, 6 psychiatric reasons, 6 medical reasons, 5 logistics, 9 refused
n= 284

Age: Mean 58

Sex: 214 males 70 females

Diagnosis:
  • 100% Depression by DSM-IV
  • 100% Cardiovascular disease by Histologically confirmed
Exclusions:
-

<18 years of age

-

HAMD <20

-

depression due to general medical condition

-

psychosis, bipolar,

-

substance abuse

-

suicide risk

-

current use of antidepressants, lithium, anticonvulsants for mood disoder

-

current psychotherapy

-

previous absence of response to citalipram or IPT

-

2 or more previous unsuccessful treatment fo the index depression

-

lifetime history of early termination of citalopram or 2 other SSRIs because of adverse events

-

MMSE < 24

-

clinician judgement that the patient would not adhere to study regime

-

coronary bypass graft surgery planned during the next 4 months

-

Canadian Cardiovascular Society Angine Class of 4

-

unable to speak French/English

Notes: severe depression according to APA criteria

Baseline: Total: HAM-D: 29.68 BDI = 30.3; HAM-D: 30.0 - IPT (+ Placebo), 30.3 - control; BDI = 29.1 - IPT (+ Placebo), 31.3 - control.
Data Used
  • Cardiovascular outcomes
  • Response (>50 reduction from baseline)
  • Remission (below cut-off)
  • BDI-II
  • HDRS-24
Notes: Dropouts: IPT + Citalopram 2/67 IPT + Placebo 6/75 Citalopram 3/75 Placebo 6/67
Group 1 N= 75
  • Citalopram - 10mg/d week1, 20mg/d, if HAMD >8 increased to max 40mg/d.
  • Clinical management - information about depression and medication use, encourage adherence, evaluate adverse events. Individual. 20-25 mins. Up to 4 could be done via telephone.
Group 2 N= 67
  • Placebo
  • Clinical management - information about depression and medication use, encourage adherence, evaluate adverse events. Individual. 20-25 mins. Up to 4 could be done via telephone.
Group 3 N= 75
  • IPT - Individual IPT, 12 weekly sessions+placebo: up to 4 sessions via telephone. Focused on dealing with interpersonal conflicts, life transitions, grief, and loss. Conducted by Doctoral or Masters level therapists with mean 15 years experience.
  • Clinical management - information about depression and medication use, encourage adherence, evaluate adverse events. Individual. 20-25 mins. Up to 4 could be done via telephone.
Group 4 N= 67
  • Citalopram + IPT - citalopram and IPT provided as described
  • Clinical management - information about depression and medication use, encourage adherence, evaluate adverse events. Individual. 20-25 mins. Up to 4 could be done via telephone.
Sponsored by Canadian Institutes of Health Research Participants recruited for major depression; intervention modifed for illness
Results from this paper:
Quality assessment score = +
LI2005
Study Type: RCT

Study Description: Raters were blind to treatment allocation but unclear from paper whether participants were also blinded

Type of Analysis: Completer

Blindness: Open

Duration (days): Mean 56

Setting: Neurology unit, CHINA, Shaanxi Province

Notes: RANDOMISATION: performed by coin toss

Info on Screening Process: 89 participants were thought to be eligible, 9 were excluded, 8 dod mpt , meet the inclusion criteria and 5 refused consent
n= 67

Age: Mean 34

Sex: 32 males 35 females

Diagnosis: Exclusions:
-

No diagnosis of epilepsy

-

No CCMD-3 diagnosis of depression

-

HAM-D <18

-

Comorbid neurological or physical illness or substance misuse

-

Refusal to consent

Notes: Daignosis of epilepsy from clinical assessment and confirmatory EEG.
All participants were on anticonvulsants

Baseline: No differences in age, duration of illness or on pretreatment HAM-D scores
Data Used
  • Adverse events
  • HAM-D
  • HAM-A
  • Response (>50 reduction from baseline)
Notes: TAKEN AT: Baseline and end of treatment DROP OUT - 0/33 trx, 3/34 (9%) control
Group 1 N= 33
  • Paroxetine. Mean dose 20-40mg - Paroxetine taken daily at a starting dose of 10mg/d, increased to 20mg/d after one week. After 4 weeks if there was a HAM-D reduction <50% fose was increased to 30-40mg/d
Group 2 N= 34
  • Doxepine. Mean dose 100mg/d - Starting dose of 25mg/d was adjusted according to response. Mean 100 mg/d (12.5mg/d)
Funding not reported
Results from this paper:
Quality assessment score = +
LIPSEY1984
Study Type: RCT

Study Description: LOCF (if in study for at least week)

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 42

Setting: US, patients in rehabilitation hospitals or outpatients

Notes: RANDOMISATION: random number table
n= 34

Age: Mean 61

Sex: 22 males 12 females

Diagnosis: Exclusions:
-

severe comprehension deficit

-

already receiving antidepressants

-

contraindication for nortriptyline

Baseline: Not reported
Data Used
  • Remission (below cut-off)
Notes: TAKEN AT: baseline and endpoint
Dropouts: Nortriptyline 3/14 Placebo 2/20
Group 1 N= 14
  • Nortriptyline - 6 week regimen: 20 mg/d week1, 50 mg/d week 2-3, 70mg/d week4, 100mg/d weeks 5-6 4 weeks regimen: 50mg/d week1, 70mg/d weeks 2-3, 100mg/d week4
Group 2 N= 20
  • Placebo
Funding: NIH grant, Sandoz Pharmaceutical company provided medication
Results from this paper:
Quality assessment score = +
LUSTMAN1997A
Study Type: RCT

Study Description: Personnel preparing treatment packs were different from those wmonitoring progress. Dummy reports were produced to ensure blinding of raters.

Type of Analysis: Completer only

Blindness: Double blind

Duration (days): Mean 56

Setting: US, Washington, St louis

Notes: RANDOMISATION: details not reported Diabetes management regimes kept constant during the study unless clinically indicated

Info on Screening Process: 180 patients evaluated to determine eligibility, 66 were excluded ont eh basis of their psychiatric interview. Present study looks at 35 subjects with active depression diagnosis
n= 28

Age: Mean 45

Sex: 11 males 17 females

Diagnosis: Exclusions:
-

aged <21 or >65

-

gHb <9% Active suicidal ideation or a history of attempted suicide

-

History of Bipolar disorder or any other psychiatric disorder

-

Current alcohol abuse or other substance abuse disorder

-

Currently taking psychoactive medications or notriptyline contraindicated

-

Pregnant or lactating women

-

History of convulsions or seizure disoder

-

Clinically significant hepatic dysfunction

-

Uniary outflow obstruction

-

Glaucoma

-

Current hypo or hyperthyroidism

-

Current ECG evidence of any cardiac conditions which preclude treatment with tricyclics

Notes: Insulin or non-insulin dependent diabetes with poor glycemic control

Baseline: BDI: Nort 19.0(7.4), Placebo 17.8(7.1)
Data Used
  • Remission (below cut-off)
  • BDI
Data Not Used
  • Physical health outcomes - F-value only without means
Notes: TAKEN AT: Baseline and end of treatment (wk8)
DROPOUT: - does not give drop out for depressed only. Total study drop out = 14%
Group 1 N= 14
  • Nortriptyline. Mean dose 25 - 50mg/day - 25mg/day increased to 50mg/day during second visit. Subsequent adjustments were made to ensure that a plasma nortriptyline level reamined within the range of 50-150 ng/ml
Group 2 N= 14
  • Placebo
Paper reports a subset of a 1988 unpublished study.
Paper only reports on those who were depressed and had poor glycemic control. Data for depressed patients presented seperately (data for non-depressed not entered into the analysis
Results from this paper:
Quality assessment +
LUSTMAN2000
Study Type: RCT

Study Description: Paper provides both ITT and completer for the dichotomous outcomes, completer only for continuous

Type of Analysis: ITT and completer

Blindness: Double blind

Duration (days): Mean 56

Setting: US, Washington, St Louis

Notes: RANDOMISATION: a computerised algorithm determined the randomisation pattern

Info on Screening Process: 65 participants gave informed consent, 5 were excluded from participation due to exclusionary psychiatric condition (1), unwilling to take medication (4)
n= 60

Age: Mean 46

Sex: 14 males 38 females

Diagnosis: Exclusions:
-

Aged <21 or >65

-

BDI <14, or HAM-D <14

-

Active suicidal ideation or a history of attempted suicide

-

History of Bipolar disorder or any other psychiatric disorder

-

Current alcohol abuse or other substance abuse disorder

-

Currently taking psychoactive medications or fluoxetine contraindicated

-

Pregnant or lactating women

-

History of convulsions or seizure disoder

-

Clinically significant hepatic dysfunction

Notes: Type I and II diabetes

Baseline: BDI: Flx 23.6(8.2), Placebo 22.4(9.1)
HAMD Flx 20.1(5.6), Placebo 19.5(6.9)
Data Used
  • Physical health outcomes
  • BDI
  • HAM-D
  • Remission (below cut-off)
  • Response (>50 reduction from baseline)
Notes: TAKEN AT: Baseline and End of treatment
DROPOUT: FLx 3/30 (10%), Placebo 3/30 (10% Leaving the study early due to adverse events: Flx 1/30, placebo 0/30
Group 1 N= 27
  • Fluoxetine. Mean dose 20-40mg/day - - Dosing began at 20mg/day and could be increased to a max of 40mg/day
Group 2 N= 27
  • Placebo
Drug-company funded - Eli Lilly Demographics and baseline for completers only
Results from this paper:
Quality assessment +
LUSTMAN2006
Study Type: RCT

Study Description: ITT with patients who did not complete the protocol being censored at the point of discontinuation I the survival estimates

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 365

Setting: Outpatient clinics USA, Washington, Seattle and Arizona

Notes: RANDOMISATION: Patients were randomised using a computer generated algorithm. Randomisation was stratified according to site. Allocation concealment.

Info on Screening Process: 389 screened, 351 statisfied the inclusion criteria and were enrolled in the open label phase of the trial. 156 completed the inducation phase of which 152 entered the maintenace phase of the trail (presented here)
n= 152

Age: Mean 53

Sex: 61 males 91 females

Diagnosis: Exclusions:
-

Non-recovery from depression durin open-label phase of trial (Initially patients were excluded if BDI <14 or HAM-D <15)

-

Aged <18

-

No diagnosis of type I or II diabetes

-

Active suicial or homicial ideation or a history of attempted suicide

-

Current alcohol or other substance misuse disorder

-

Medical contraindication to sertraline treatment

Notes: Study is looking at the prevention of relapse in patients who recovered from depression during an open-label phase of the trial. See notes for further details

Baseline: Maintenance phase:
BDI: sertraline 4.4(3.0) Placebo 3.5(2.6)
Data Used
  • Time to relapse
Notes: TAKEN AT: trial could continue up to 52 weeks or until a relapse of depression occurred.
DROPOUT: 15/79 sertraline (19%), Placebo 7/73 (19%)
Group 1 N= 79
  • Sertraline. Mean dose 118mg/day - Participants begain the open-phase of the study on 50mg/day which could be adjusted to a max of 200mg/day. In the randomised phase of the trail, blinded tappering was achieved by dovetailing the induction and maintenance medication.
Group 2 N= 73
  • Placebo - During a two-week period after randomisation, the induction medication was gradually reduced and the maintence medication, in this case placebo increased.
Drug-company sponsored study - Pfizer NY Recovery from depression was defined per DSM-IV citeria as a period of >=2 months during which there were no significant symptoms of depression
Results from this paper:
Quality assessment ++
MAURI1994
Study Type: RCT

Blindness: Double blind

Duration (days): Mean 56

Setting: Italy,

Notes: RANDOMISATION: no further details
n= 26

Age: Mean 35

Sex: 19 males 6 females

Diagnosis: Baseline: HDRS: Fluoxetine 30.37 (1.31) Placebo 29.50 (6.94)
Data Used
  • HDRS
Notes: no information on dropouts
Group 1 N= 16 Group 2 N= 10
  • Placebo
funding: no information
Results from this paper:
Quality assessment score = +
MCFARLANE2001
Study Type: RCT

Blindness: Double blind

Duration (days): Mean 180

Setting: Coronary Care Unit, Canada

Notes: RANDOMISATION: no further details
n= 38

Age: Mean 62

Sex: 23 males 15 females

Diagnosis:
  • 100% Cardiovascular disease
Exclusions:
-

<15 Inventory to Diagnose Depression before discharge and 2 weeks later

-
Data Used
  • Cardiovascular outcomes
Notes: Dropouts: Sertraline 6/18 Placebo 5/20
Group 1 N= 18 Group 2 N= 20
  • Placebo
Sponsorship by Heart and Stroke Foundation of Ontario All received access to multidisciplinary care: exercise rehab, nutrition, counselling
Results from this paper:
Quality assessment score = +
MENZA2008
Study Type: RCT

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 56

Setting: US

Notes: Randomisation: no further details
n= 52

Age: Mean 63

Sex: 27 males 25 females

Diagnosis: Exclusions:
-

MMSE <26

-

psychiatric diagnosis other than depression or anxiety

Baseline: HAMD: Paroxetine 18.82 (5.6) Nortriptyline 21.12 (5.64) Placebo 19.29 (5.64)
Data Used
  • Response (>50 reduction from baseline)
  • HAM-D
Notes: TAKEN AT: Baseline and endpoint
DROPOUT: Paroxetine 7/18, Nortriptyline 5/17, Placebo 6/17
Group 1 N= 18
  • Paroxetine. Mean dose 28.4mg - Flexible dosing started at 12.5mg and could be increased to 37.5mg
Group 2 N= 17
  • Nortriptyline. Mean dose 48.5mg - Flexible dosing started at 25mg could be increased to 75mg
Group 3 N= 17
  • Placebo
NIH funded trial
Results from this paper:
Quality assessment score = +
MORROW2003
Study Type: RCT

Study Description: * Data analysis was limited to patients who provided complete data. LOCF was used for 43 patients who provided cycle 3 but not cycle 4 data

Type of Analysis: completer*

Blindness: Double blind

Duration (days):

Followup: up to cycle 4 of chemotherapy

Setting: 18 oncology private-practice groups, US

Notes: RANDOMISATION: accomplished centrally using a computer-generated random-numbers table.

Info on Screening Process: 902 patients met initial medical eligibility criteria.
-

198 (22%) did not continue as they were no longer medically eligible, did not complee the baseline questionnaires or refused random assignement

-

155 patients did not meet the fatigue criteria

n= 549

Age: Mean 56 Range 23-84

Sex: 116 males 363 females

Diagnosis: Exclusions:
-

<18 yrs

-

cancer patients who were not scheduled to begin the first of >=4 cycles of chemotherapy without concurrent radiotherapy of interferon treatment

-

use of psychotropic medications, MAOIs, tryptophan or warfarin

-

history of mania or seizures

-

reported havined been hospitalised for any psychiatric condition

-

Patients not reporting fatigue (as assessed by MAF) after cycle 2 of chemotherapy

Notes: 32% of the sample had a CES-D >19 (defined by authors as cut-off for depression)

Baseline: CES-D: paroxetine: 14.8 (SE 0.67), placebo: 15.8 (SE 0.67)
POMS: paroxetine: 3.1 (SE 0.22), placebo: 3.7 ( 0.27)
Data Used
  • POMS
  • CES-D
Notes: TAKEN AT: cycle 2 (Baseline), cycle 4 (endpt)

DROPOUT: Paroxetine: 33/277, placebo: 37/272 Leaving the study due to adverse events: 2 - does not state which group
Group 1 N= 277 Group 2 N= 272
  • Placebo - Identical looking placebo
Drug company sponsored: GlaxoSmith-Kline Supoprted by a National Cancer Institute Grant
Results from this paper:
Quality assessment score = +
MURRAY2005A
Study Type: RCT

Study Description: LOCF

Blindness: Double blind

Duration (days): Mean 180

Setting: Sweden, stroke centres

Notes: RANDOMISATION: conducted at the Central Pharmacy in Stockholm, each centre pharmacy received presealed treatment packages.

Info on Screening Process: 260 screened, 137 excluded - other serious/terminal illness (n=10), treatment of other psychiatric problem (n=8), difficulties adhering to protocol (n=18), does not wish to participate (n=54), already on antidepressant (n=40), suicidal (n=3),
n= 123

Age: Mean 71

Sex: 59 males 64 females

Diagnosis: Exclusions:
-

MADRS <10

-

severe ability to communicate

-

acute MI

-

psychiatric illness other than depression

-

significant risk of suicide

-

current use of psychotropic or analgesic drugs

Baseline: MADRS: Sertraline 18.9 (6.1) Placebo 19.6 (6.1) Major Depression n=76 Minor depression n=61
Data Used
  • ADL
  • MADRS
Notes: Dropouts: Sertraline 24/62 Placebo 30/61
Group 1 N= 62
  • Sertraline - 50mg/d weeks 1-4, after 4 weeks could be increased to 100mg/d according to investigators discretion. After 6 weeks had to display 20% reduction from baseline on MADRS to continue.
Group 2 N= 61
  • Placebo - After 6 weeks had to display 20% reduction from baseline on MADRS to continue.
Funding: Unrestricted grant from Pfizer; also grants from AFA Insurances, and Marianne and Marcus Wallenberg Foundation
Results from this paper:
Quality assessment score = +
MUSSELMAN2006
Study Type: RCT

Study Description: ITT population with LOCF approach applied for the missing data

Type of Analysis: ITT and completer

Blindness: Double blind

Duration (days): Mean 42

Followup: 6 months

Setting: 2 centres

Notes: RANDOMISATION: not reported

Info on Screening Process: Details not reported
n= 35

Age: Mean 54

Sex: all females

Diagnosis: Exclusions:
-

Aged <18 or >75

-

Pregnant women and women of childbearing potential not using contraception, lactating women

-

Serious suicidal risk

-

History of urinary retention, intracranial metastases, angina pectoris, MI, arrhythmia, presence of conduction detects or any serious CVD

-

Serious illness incuding cardiac, hepatic, renal, respiratory, endocrinologic, neurologic or hematologic disease of such instability that hospitalisation is likely in the next 2 months

-

DSM-III-R diagnosis of organic mental disorder, alcohol and/or substance use disorder, paranoid or psychotic symptoms, or bipolar disorder

Baseline: HAMD: Paroxetine: 21.00 (5.66), Desipramine 23.00 (6.16), Placebo 23.91 (4.99)
HAMA: Paroxetine: 19.62 (7.19), Desipramine 18.45 (6.67), Placebo 21.82 (8.54)
CGI-S: Paroxetine: 3.85 (0.69), Desipramine 4.00 (0.77), Placebo 4.18 (0.40)
Data Used
  • Adverse events
  • Response (>50 reduction from baseline)
  • Remission (below cut-off)
  • CGI-S
  • HAM-D
  • HAM-A
Notes: TAKEN AT: baseline, post-treatment and 6 month FU
DROPOUT: Paroxetine 5/13, Desipramine 5/11, Placebo 5/11
Leaving the study early due to adverse events: Paroxetine 2/13, Desipramine 1/11, Placebo 2/1
Group 1 N= 13
  • Paroxetine. Mean dose 31mg - 20mg/day for 4 wks, dose could be increased to 40mg/d
Group 2 N= 11
  • Desipramine. Mean dose 113mg - 25g/evening for 3 days, increased to 50mg/evening for 4 days with subsequent forced titration to 125mg/day at the rate of 25mg ever 7 days during 2nd, 3rd and 4th weeks. After titration dose increases of 25mg/day permitted every 3 days up max 200mg/day.
Group 3 N= 11
  • Placebo
Drug company sponsored: GlaxoSmithKline
Results from this paper:
Quality assessment score = +
NELSON1999
Study Type: RCT

Study Description: ITT (LOCF)

Blindness: Double blind

Duration (days): Mean 42

Setting: US

Notes: RANDOMISATION: no further details
n= 81

Age: Mean 58

Sex: 67 males 14 females

Diagnosis:
  • 100% Depression by DSM-III-R
  • 100% Cardiovascular disease
Exclusions:
-

< 18 years

-

HAMD-17 <16

-

psychosis, bipolar, substance abuse

-

baseline QTc >460msec

-

unstable angina

-

MI within 3 months

Baseline: HAMD = 22.6
Data Used
  • Remission (below cut-off)
  • Response (>50 reduction from baseline)
Notes: Dropouts: Paroxetine 4/41 Nortriptyline 14/40
-

due to adverse events: Paroxetine 2/41 Nortriptyline 10/40

Group 1 N= 41
  • Paroxetine - Starting dose of 20mg/d unless over 65 years (then 10mg/d). After week 3 increased to 30mg/d if required up to a max of 40mg/d.
Group 2 N= 40
  • Nortriptyline - Nortriptyline plasma concentrations determined at week 1, 2 and 6. Dose adjusted to obtain blood leve between 50 and 150 ng/ml
Sponsored by drug company (Smith Kline Beecham)

severe depression
Results from this paper:
Quality assessment score = +
PAILEHYVARINEN2003
Study Type: RCT

Study Description: LOCF used for patients who completed at least 2 weeks of the trial

Blindness: Single blind

Duration (days): Mean 70

Setting: Not stated

Notes: RANDOMISATION: computerised and concealed to both patient, investigators and treating physicians until inclusion and informed consent was established.

Info on Screening Process: 22 participants were screened of which 7 were excluded as they failed to meet inclusion criteria
n= 15

Age: Mean 61

Sex: all females

Diagnosis: Exclusions:
-

Male

-

pre-menipausal, aged <50

-

unstable antidabetic medication in previous 3 months

-

GHbA1c <6.5% or fasting blood glucose <7.0 mmol/l

-

MADRS score <2.5 or >12

-

Major complications due to diabetes including CVD, renal failure

-

Glaucoma,

-

Use of warfarin

-

Use of any kind of antidepressant

Notes: All participants had unsatisfactory glycemic control

Baseline: MADRS: Paroxetine 7.4(2.9), Placebo 6.4(4.0)
BDI: Paroxetine 13.7(7.4), Placebo 13.0(9.2)
Data Used Notes: TAKEN AT: Baseline and end of treatment
DROPOUT: Paroxetine 0/7, placebo 2/8
Adverse events: Paroxetine 4/7, placebo 3/7
Group 1 N= 7 Group 2 N= 8
  • Placebo
competing interests: non declared
Results from this paper:
Quality assessment +
PAILEHYVARINEN2007
Study Type: RCT

Study Description: Identical tablets were packed in identical vials according to the randomisation schedule.

Type of Analysis: Completer only

Blindness: Double blind

Duration (days): Mean 182

Setting: Outpatients FINLAND, Helsinki

Notes: RANDOMISATION: computerised and concealed to participants, investigators and treating physicians. Investigators were not involved in treatment.

Info on Screening Process: 73 interview, 23 did not meet incusion criteria. Most common reason for exclusion was good glycemic control. 6 particiapnts withdrew consent before starting medication
n= 49

Age: Mean 59

Sex: 33 males 10 females

Diagnosis: Exclusions:
-

Aged <50 or >70

-

Good glycemic control - GHbA1c <7.5%

-

Moderate to severe depression as defined by >6 items on DSM criteria

-

Glucoma

-

Using warfarin

-

Major complications due to diabetes

-

using any kind of antidepressant

Notes: All participants met criteria for mild depression

Baseline: HADS Prx 14.0(5.2), Placebo 15.7(5.5)
SF-36: Prx 56.2(17.4), Placebo 48.5(15.7)
Data Used
  • Adverse events
  • SF-36
  • Physical health outcomes
  • HADS
Notes: TAKEN AT: baseline and end of treatment (6 months)
DROPOUT: Prx: 1/24 (4%), Placebo 11/25 (44%
Group 1 N= 23 Group 2 N= 20
  • Placebo
Drug company sponsored - GlaxoSmithKline Baseline demographics only provided for the 43 participants who received medication
Results from this paper:
Quality assessment +
PEZZELLA2001
Study Type: RCT

Study Description: ITT: all patients who had taken at least one dose of study medication and who had at least one on-dose efficacy assessment. LOCF used for missing data

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 56

Setting: 25 centres in Austria, Belgium, Canada, Germany, Italy and The Netherlands

Notes: RANDOMISATION: details not reported Double-dummy technique used to ensure blinding

Info on Screening Process: 194 were eligible for entry into the study 179 participants were randomised with 175 receiving at least one dose of study medication
n= 179

Age: Mean 51 Range 34-72

Sex: all females

Diagnosis: Exclusions:
-

MADRS <16

-

WHO perforrmance status >2

-

Life expectancy <3 months

-

Male

-

Marked hepatice dysfunction, renal dysfunction or sever co-existing diseases

-

received depot neuroleptic in past 6 months, oral neuroleptic in past 2 months, MAOI or SSRI in past 4 weeks, lithium treatment of ECT within 8 weeks or a tri or tetra-cyclic antidepressant in previous 7 days.

-

Treated with an investigational compound within past 30 days or 5 half-lives, endocrine therapy in past 4 weeeks.

-

Considered to be at risk of suicide

-

Breast feeding, likely to become pregnant

-

Diagnosis of schizophrenia, bipolar disorder or other psychoses

-

Known abusers of alcohol or drugs

-

Clinically significant ECG or abnormal laboratory values

-

Previously treated with paroxetine or known sensitivity to SSRIs ot TCAs

-

If likely to need surgery, scheduled for total body irradiation, spinal or abdominal radiotherapy

-

undergoing formal psychotherapy

Baseline: FLC: Paroxetine 87.5 (18.6), Amitriptyline 95.0 (20.0)
Data Used
  • Adverse events
  • Response (>50 reduction from baseline)
  • Functional Index of Living
  • CGI-I
  • CGI-S
  • MADRS
Notes: TAKEN AT: Baseline and post-treatment
DROPOUT: Paroxetine: 17/89 (19%), Amitriptyline: 22/90 (22%)
Leaving the study early due to adverse events: Paroxetine 9/89 (10%), Amitriptyline 10/90(11.5%
Group 1 N= 89
  • Paroxetine. Mean dose 20-40mg - Administerd at 20mg/day for 3 weeks, thereafter dose could be increased to 30mg/day. After week 5 dose could be further increased to 40mg/day or reduced to 20mg/d
Group 2 N= 90
  • Amitriptyline. Mean dose 75-150mg - Initial dose titration of 25mg/day for 3 days, followed by 50mg/day days 4-7 then 75mg/day for 2 weeks, thereafter dose could be increased to 100mg/day. After week 5 dose could be further increased to 150mg/day or reduced to 75mg/day
No mention of funding
Results from this paper:
Quality assessment score = +
POLLOCK2000
Study Type: RCT

Type of Analysis: completer only

Blindness: Double blind

Duration (days): Mean 42

Setting: US

Notes: RANDOMISATION: non further details
n= 20

Age: Mean 59

Sex: 17 males 3 females

Diagnosis:
  • 100% Depression by DSM-III-R
  • 100% Cardiovascular disease
Exclusions:
-

< 3 months post MI, <3 months post coronary bypass graft, or <60% occlusion of major coronary artery

-

HAMD <15

-

psychosis, bipolar

Baseline: HAMD = 20
Data Used
  • Cardiovascular outcomes
Notes: no information on dropouts
Group 1 N= 10
  • Paroxetine - Initiated at 10mg/d, 20mg/d at second week
Group 2 N= 7
Sponsored by Merck/American Federation for Aging Research Fellowship, National Institute for Mental Health and National Heart, Lung, and blood institute
Results from this paper:
Quality assessment score = +
RABKIN1994
Study Type: RCT

Type of Analysis: completer only

Blindness: Double blind

Duration (days): Mean 42

Setting: US

Notes: RANDOMISATION: no further details
n= 97

Age: Mean 38

Sex: 92 males 5 females

Diagnosis: Exclusions:
-

current risk of suicide

-

previous treatment with imipramine during episode

-

substance abuse

-

schizophrenia or bipolar disorder

Baseline: HDRS: Imipramine 17.5 (4.1) Placebo 16.1 (4.0)
Data Used
  • Remission (below cut-off)
  • Response (>50 reduction from baseline)
  • HDRS
Notes: Dropouts: Imipramine 12/50 Placebo 5/47
Group 1 N= 50
  • Imipramine - 50mg/d for 3days, 100mg/d for 4 days, 150mg/d for a week then 200mg/d for rest of study
Group 2 N= 47
  • Placebo
funding: NIMH grant, Ciba-Geigy Corp provided medication
Results from this paper:
Quality assessment score = +
RABKIN1999
Study Type: RCT

Blindness: Double blind

Duration (days): Mean 56

Setting: US

Notes: RANDOMISATION: no further details
n= 120

Age: Mean 39

Sex: 117 males 3 females

Diagnosis: Exclusions:
-

psychosis or bipolar

-

substance misuse

-

panic disorder

-

suicide risk

-

significant cognitive impairment

-

HIV wasting syndrome

-

significant diarrhea

Baseline: HDRS: Fluoxetine 19.6 (4.7) Placebo 18.6 (5.1)
Data Used
  • Remission (below cut-off)
  • Response (>50 reduction from baseline)
  • HDRS
Notes: Dropouts: Fluoxetine 24/81 Placebo 9/39
Group 1 N= 81
  • Fluoxetine - 20mg/d starting dose, increased by further 20mg/d bi-weekly depending on response
Group 2 N= 39
  • Placebo
Funding: NIMH grant, Eli Lilly provided medication
Results from this paper:
Quality assessment score = +
RABKIN2004
Study Type: RCT

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 56

Setting: US

Notes: RANDOMISATION: computer generated numbers
n= 123

Age: Mean 41

Sex: all males

Diagnosis: Exclusions:
-

substance abuse

-

psychosis

-

suicide risk

-

cognitive impairment

-

unstable medical condition

Baseline: HRSD: Fluoxetine 18.2 (4.5) Placebo 16.8 (3.3)
Data Used
  • Remission (below cut-off)
  • Response (>50 reduction from baseline)
Notes: Dropouts: Fluoxetine 16/46 Placebo 9/39 Testosterone 8/38
Group 1 N= 39
  • Placebo
Group 2 N= 38 Group 3 N= 46
Funding: NIMH grant, Lilly provided medication
Results from this paper:
Quality assessment score = +
RAFFAELE1996
Study Type: RCT

Study Description: Data used in the analysis not reported (assumed completer only)

Type of Analysis: Not reported

Blindness: No mention

Duration (days): Mean 30

Setting: Italy, stroke rehabilitation program

Notes: RANDOMISATION: no further details
n= 22

Age: Mean 70

Sex: 13 males 9 females

Diagnosis: Exclusions:
-

aphasia

-

No DSM-III-R diagnosis of depression at baseline

Baseline: Zung depression scale: Trazadone 62.4 (11.8) Placebo 59.2 (10.3)
Data Used
  • ADL
  • Zung
Notes: TAKEN AT: Baseline and endpoint
DROPOUT: not reported
Group 1 N= 11
  • Trazadone. Mean dose 300mg
Group 2 N= 11
  • Placebo
no information on funding provided
Results from this paper:
Quality assessment score = +
RAMPELLO2004
Study Type: RCT

Blindness: Double blind

Duration (days): Mean 112

Setting: Italy, community-based

Notes: RANDOMISATION: computer generated by physician not involved in evaluation of patients

Info on Screening Process: 95 screened, 16 did not meet eligiblity criteria, 5 refused to participate
n= 74

Age: Mean 74

Sex: 35 males 39 females

Diagnosis: Exclusions:
-

HDRS <20

-

BDI <15

-

previous degeneerative or expansive neurological diseases, tumours, MS, Binswanger's disease,

-

psychiatric illness (except depression)

-

severe aphasia, cognitive deficit, impaired consciousness, heart disease

Baseline: HDRS for anxious depression: Citalopram 22.39 (2.09) Placebo 22.83 (2.41)
HDRS for retarded depression: Citalopram 22.75 (1.71) Placebo 22.66 (1.37)
Data Used
  • HDRS
  • BDI
Notes: Dropouts:
Group 1 N= 37 Group 2 N= 37
  • Reboxetine. Mean dose 4mg/d
Group 3 N=
  • Reboxetine
no information on funding
Results from this paper:
Quality assessment score = +
RAZAVI1996
Study Type: RCT

Study Description: ITT based on all randomised patients for success rate response rate and side-effects. Completer data used for scale results.

Type of Analysis: ITT and completer

Blindness: Double blind

Duration (days): Mean 30

Setting: Multicentre

Notes: RANDOMISATION: stratification based on centre, no further details reported

Info on Screening Process: 24 patients were not randomised after the 1-week placebo triail due to (n):
-

HADS <13 (9)

-

Non-compliant (13)

-

Concomitant medical events (2)

-

Manic episode (1)

-

unspecified reasons (3)

n= 91

Age: Mean 53

Sex: 17 males 74 females

Diagnosis: Exclusions:
-

HADS <13

-

Major depressive disorders with melancholic features, Bipolar disorder

-

Alcohol abuse in previous year

-

Uncontrolled pain, uncontrolled somatic comorbidities

-

Brain trumors or those receiving CNS-targeted treatments

-

Life expectancy <3 months

-

undergoing abdominal or thoracic surgery in last 6 weeks, >15 days corticosteroid treatment

-

Women who were pregnant or breast feeding

-

psychotropic drug use in previous 2 weeks or taking antidepressants, neuroleptics, lithium or procarbazine

-

Fluoxetine or MAOI treatment in previous 6 weeks

Notes: Patients had to suffer from an adjustment disorder (with depressive mood or mixed features) or a major depressive disorder in relation to the cancer disease that had been diagnosed for a period between 6weeks - 7 years

Baseline: Not reported for whole sample, completers only
Data Used
  • Global Severity Index (GSI)
  • MADRS
  • HAM-A
  • HADS
  • Remission (below cut-off)
  • Response (>50 reduction from baseline)
Notes: TAKEN AT: Baseline, end of treatment
DROPOUT: Fluoxetine 15/45 (33%), Placbo 7/46 (15%)
Leaving the study due to adverse effects: Fluoxetine 7/45, Placebo 2/46
Group 1 N= 46
  • Placebo
Group 2 N= 45
Drug company sponsored: Lilly France and Lilly Benelux
Results from this paper:
1.Quality assessment score = +
ROBERTSON1985
Study Type: RCT

Type of Analysis: completer

Blindness: Double blind

Duration (days): Mean 35

Followup: 6 week

Setting: UK, LONDON

Notes: RANDOMISATION: hospital pharmacist conducted randomisation and kept study codes to ensure blinding

Info on Screening Process: 80 consecutive referrals were screened, with 66 meeting cirteria for MDD and epilepsy. Of the 66, 42 were eligible and agreed to participate
n= 42

Age: Mean 36

Sex: 16 males 26 females

Diagnosis: Exclusions:
-

HAM-D <15

-

Pregnant

-

receiving psychotropic medication or ECT considered

-

<18 or >70 years

-

English speaking

-

evidence of cognitive impairment or progressive disorder of the central nervous system

Baseline: No differences at baseline
Data Used Notes: TAKEN AT: Baseline, week 6 (end of treatment) and week 12 (follow up)
DROP OUT: unclear 3/42 in whole study
Group 1 N= 13
  • Amitriptyline. Mean dose 25mg tid - Dose could be doubled in non-responders
Group 2 N= 13
  • Nomifensine. Mean dose 25mg tid - Dose could be doubled in non-responders
Group 3 N= 13
  • Placebo
Only head-to-head arm used, no useable data for TCA vs. placebo Non drug company sponsored
Results from this paper:
Quality assessment score +
ROBINSON2000
Study Type: RCT

Study Description: Used a cross over design 12 weeks of active treatment followed by 12 weeks of placebo. Data analysed for first 12 weeks only.

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 84

Setting: US, Rehabilitation Centre

Notes: RANDOMISATION: no further details
n= 56

Age: Mean 67

Sex: 31 males 25 females

Diagnosis: Exclusions:
-

any other significant medical illness

-

severe comprehension deficit

-

prior history of head injury

-

prior history of other brain disease other than stroke

Baseline: HDRS: Fluoxetine 20.4 (4.7) Placebo 17.5 (6.2)
Data Used
  • MMSE
  • Functional independence
  • HAM-A
  • HADS
Notes: TAKEN AT: Baseline and endpoint
Dropouts: Fluoxetine 9/23 Nortriptyline 3/16 Placebo 4/17
Group 1 N= 23
  • Fluoxetine - 10mg/d for first 3 weeks, 20mg/d for weeks 4-6, 30mg/day for weeks 7-9, 40mg/d final 3 weeks
Group 2 N= 16
  • Nortriptyline - 25mg/d first week, 50mg/d weeks 2-3, 75mg/d weeks 3-6, 100mg final 6 weeks
Group 3 N= 17
  • Placebo
funding: NIMH, Raul Carrea Institute of Neurological Research; Eli Lilly provided fluoxetine and placebo
Results from this paper:
Quality assessment score = +
SCHIFANO1990
Study Type: RCT

Study Description: No details given - assumed completer only

Type of Analysis: No mention

Blindness: Double blind

Duration (days): Mean 28

Setting: Italy

Notes: RANDOMISATION: procedure not reported

Info on Screening Process: No details reported
n= 48

Age: Mean 76

Sex: 8 males 40 females

Diagnosis: Exclusions:
-

<65 years

-

no diagnosis of MDD or dysthymic disorder according to DSM-III

-

Bipolar disorder

-

presence of dementia

-

treatment with antidepressant drugs or ECT in previous 2 weeks

-

schizophrenia or other psychotic disorders

-

diagnosis of alcohol abuse or dependence, and/or substance abuse or dependence

-

evidence of a history of allergy to any of the study drugs

Notes: Participants were recruited from the internal disease unit of a general medical hospital. All participants had a physical health probelsm and were classed as medically ill. Main conditions included cardiac diseases and arthrosis

Baseline: No difference at baseline: GDS: Mianserin 18(6.1) Maprotiline 20(5.1)
Data Used
  • GDS
  • Response (>50 reduction from baseline)
Notes: TAKEN AT: Baseline and 28 days (end of treatment)
DROP OUT: Mianserin 5/25 Maprotiline 8/23
Group 1 N= 25
  • Mianserin - 2 capsules were administered in the first week (45mg), dosage increased to 3 capsules (67.5mg) for remaining weeks. The investigator was able to increase dosage to 4 capsules (90mg) on the basis of response and side effects.
Group 2 N= 23
  • Maprotiline - 2 capsules were administered in the first week (75mg), dosage increased to 3 capsules (112.5mg) for remaining weeks. The investigator was able to increase dosage to 4 capsules (150mg) on the basis of response and side-effects.
Details of funding not reported
Results from this paper:
Quality assessment score +
SCHWARTZ1999
Study Type: RCT

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 42

Setting: US

Notes: RANDOMISATION: no further details
n= 14

Age: Mean 36

Sex: all females

Diagnosis: Exclusions:
-

<14 HSRD-17

-

other Axis I and II psychiatric disorders

-

substance abuse

-

use of other psychotropic drugs

Baseline: HRSD: Fluoxetine 20.88 (6.01) Desipramine 22.00 (10.82)
Data Used
  • HDRS-17
Notes: TAKEN AT: baseline and endpoint

Dropouts: Fluoxetine 0/8 Desipramine 2/6
Group 1 N= 8 Group 2 N= 6 Funding: Eli Lilly
Results from this paper:
Quality assessment score = +
SCT-MD-24
Study Type: RCT

Study Description: ITT using LOCF

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 84

Setting: US

Notes: Randomisatisation: no further details
n= 168

Age: Mean 54

Sex: 89 males 79 females

Diagnosis: Exclusions:
-

pregnant or breast feeding women

-

bipolar disorder, schizophrenia, personality disorder

-

learning disabilities

Baseline: HAMD: Escitalopram 26.16 Placebo 27.67
Data Used
  • Quality of life (physical)
  • HAM-A
  • HAM-D
  • CGI-I
  • Response (>50 reduction from baseline)
  • MADRS
Notes: TAKEN AT: Baseline and endpoint
DROPOUT: Escitalopram 14/84; Placebo 12/84
Group 1 N= 84 Group 2 N= 84
  • Placebo
Results from this paper:
quality assessment score = ++
STRIK2000
Study Type: RCT

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 63

Followup: continuation phase for further 16 weeks

Setting: Departments of Cardiology and Psychiatry, Netherlands

Notes: RANDOMISATION: no further details

Info on Screening Process: 556 eligible, 199 refused to participate, 4 died, 285 did not meet DSM criteria, 12 dropped out at later stage, 2 exclude because ATVI <20cm
n= 54

Age: Mean 56

Sex: 38 males 16 females

Diagnosis: Exclusions:
-

<18 years of age

-

HAMD <17

-

<3 months before >12months after MI

-

psychosis, bipolar, pregnancy

Baseline: HAMD = 21.6
Data Used
  • Cardiovascular outcomes
  • HDRS
Notes: dropouts:
Group 1 N= 27
  • Fluoxetine - Starting dose 20mg/d, could be increased to 40mg/d in week 3, 60mg/d in week 6
Group 2 N= 27
  • Placebo
Drug company sponsored (Eli Lilly)
Results from this paper:
Quality assessment score = +
TAN1994
Study Type: RCT

Type of Analysis: Completer only

Blindness: Double blind

Duration (days): Mean 36

Setting: UK, LONDON

Notes: RANDOMISATION: procedure not reported

Info on Screening Process: No details reported
n= 63

Age: Mean 80

Sex: 21 males 42 females

Diagnosis: Exclusions:
-

<65 years old

-

Moderate or severe cognitive impairment (AMT >7/10)

-

life-threatening illness

-

pre-existing antidepressant therapy

-

medical contraindications

-

history of dysrthythmias, urinary retention, glaucoma and previous allergies

-

Suicidal ideation

-

GDS <15

Notes: Participants were recruited from general medical wards and had a range of medical illnesses

Baseline: No differences at baseline: GDS Lofepramine 17.0(4.3) Placebo 16.6(3.3)
Data Used
  • Adverse events
  • GDS
  • MADRS
Notes: TAKEN AT: Baseline and 36 days post randomisation (28 days of intervention) (end of treatment)
Group 1 N= 32
  • lofepramine. Mean dose 70mg - Active drug and placebo tablets were identical and administered in same fashion
Group 2 N= 31
  • Placebo - Active drug and placebo tablets were identical and administered in same fashion
No details about funding reported
Results from this paper:
Quality assessment score +
TOLLEFSON1993
Study Type: RCT

Study Description: ITT using LOCF

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 42

Setting: US, California

Notes: RANDOMISATION: procedure not reported

Info on Screening Process: of the 671 participants to enter the study, 82.7% had at least one current chronic illness.
n= 596

Age:

Sex: no information

Diagnosis: Exclusions:
-

No diagnosis of depression according to DSM-III-R criteria

-

<60 years old

-

HAM-D < 16

-

<26 MMSE

-

Serious suicidal risk

-

Serious or unstable medical co-morbidity

-

Other DSM-III-R axis I disorders or presence of psychosis

Notes: All participants included in the analysis had at least one current chronic illness, the most common illnesses were joint disease and CVD

Baseline: No differences reported at baseline: HAMD: Flx approx 24 Placebo approx 24
Data Used
  • HAM-D
Notes: TAKEN AT: Baseline and 6 weeks (end of treatment)
DROP OUT: unclear for sub-group analysis
Group 1 N= 301 Group 2 N= 295
  • Placebo
Sub-groups with phsyical illnesses (as reported in small et al 1996) used in the analysis.
Results from this paper:
Quality assessment score +
VANDENBRINK2002
Study Type: RCT

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 56

Followup: 24 weeks entire treatment

Setting: Netherlands, nested RCT within MIND-IT trial

Notes: RANDOMISATION: performed by central randomisation centre and stratified based on study centre and patient characteristics
n= 94

Age: Mean 58

Sex: 73 males 21 females

Diagnosis: Exclusions:
-

other psychiatric problem

-

<18 years

Data Used
  • BDI
  • HDRS
Notes: Dropouts: 8weeks - Mirtazapine 10/47 Placebo 3/44
24weeks - Mirtazapine 15/47 Placebo 23/41
Group 1 N= 47
  • Mirtazapine - 30mg/d for weeks 1-2, lowered to 15mg/d if adverse events or increased to 45 mg/d if lack of response
Group 2 N= 44
  • Placebo
Sponsored by Netherlands Heart Foundation and unrestricted grants from drug companies (Lundbeck and Organon)
Results from this paper:
Quality assessment score = ++
VANHEERINGEN1996
Study Type: RCT

Study Description: ITT included those patients who had received at least one post-baseline efficacy assessment. LOCF analysis used to substitute missing data

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 42

Setting: University hospital, Gent, BELGIUM

Notes: RANDOMISATION: details not reported
n= 55

Age: Mean 52

Sex: all females

Diagnosis: Exclusions:
-

Male

-

<18 yrs

-

Not meeting DSM-III criteria for depression

-

HAM-D 16

Notes: women were included is they had a confirmed diagnosis of breast cancer Stage I or II, with no metastases and not qualifying for primary surgical treatment.

Baseline: HAMD: Mianserin 21.0 (3.6), Placebo: 21.6 (5.4)
Data Used
  • Adverse events
  • Response (>50 reduction from baseline)
  • HAM-D
Notes: TAKEN AT: Baseline, day 14, Day 28 and Day 42 (end of treatment)
DROPOUT: Mianserin 6/28 (21%), placebo 15/2 (56%)
Leaving the study due to adverse events: Mianserin 2/28, placebo 4/27
Group 1 N= 28
  • Mianserin. Mean dose 60mg - 30mg/day for week 1, increased to 60mg/day for the remainder of the study
Group 2 N= 27
  • Placebo - Indistinguishable capsules given as a single night-time dose
Drug company sponsored: NV Organon
Results from this paper:
Quality assessment score = +
WERMUTH1998
Study Type: RCT

Study Description: ITT used LOCF, completer analysis also conducted

Type of Analysis: Both ITT and completer

Blindness: Double blind

Duration (days): Mean 42

Followup: 52 week continuation

Setting: Denmark, outpatients

Notes: no further details on randomisation
n= 37

Age: Mean 64

Sex: 16 males 21 females

Diagnosis: Exclusions:
-

<35 years

-

HDRS <13

-

dementia

-

schizophrenia, psychosis

-

severe medical disorders

-

substance abuse

Baseline: HDRS-17: Citalopram 16.61 (3.08) Placebo 16.16 (3.08)
Data Used
  • Response (>50 reduction from baseline)
  • HDRS
Notes: TAKEN AT: Baseline, endpoint and follow up (not useable)
Dropouts: Citalopram 5/18 Placebo 2/19 (6 weeks acute phase)
Citalopram 12/18 Placebo 15/19 (52 weeks - data not usable)
Group 1 N= 18
  • Citalopram - Starting dose of 10mg if over 65 years or 20mg if under 65 years. Dose reassessed at 6 weeks - non-responders dose was doubled.
Group 2 N= 19
  • Placebo
Funding: Lundbeck
Results from this paper:
Quality assessment score = +
WIART2000
Study Type: RCT

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 45

Setting: France, Neurorehabilitation unit

Notes: RANDOMISATION: no further details

Info on Screening Process: 121 screened
n= 31

Age: Mean 68

Sex: 15 males 16 females

Diagnosis: Exclusions:
-

MADRS <19

-

MMSE <23

-

severe aphasia

-

previous stroke

Baseline: MADRS: Fluoxetine 28.5(7.7) Placebo 27.2(6.3)
Data Used
  • Response (>50 reduction from baseline)
  • MMSE
  • MADRS
Notes: TAKEN AT: baseline and endpoint
Dropouts: Fluoxetine 2/16 Placebo 0/15
Group 1 N= 16 Group 2 N= 15
  • Placebo
Drug company? Lilly France
Results from this paper:
Quality assessment score = +
WISE2007
Study Type: RCT

Study Description: analysed in group randomly allocated to regardless of actual study participation.

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 7

Setting: US

Notes: Randomisation: no further details
n= 233

Age: Mean 73

Sex: 83 males 150 females

Diagnosis: Exclusions:
-

psychiatric diagnosis other than MDD or mild dementia

-

moderate to severe dementia or learning disability

-

over 65 years of age

Baseline: HAMD: Duloxetine 22.5(3.4) Placebo 22.2(3.8)
Data Used
  • Response (>50 reduction from baseline)
  • Remission (below cut-off)
  • HAM-D
Notes: TAKEN AT: Baseline and endpoint
DROPOUT: not reported for phsyical ill health on
Group 1 N= 155 Group 2 N= 78
  • Placebo
Analysis was broken down into those with and without a chronic physical health problem. Only data on those with a chronic physical health problem has been extracted.
Results from this paper:
Quality assessment score = +
YANG2002
Study Type: RCT

Type of Analysis: completer only

Blindness: No mention

Duration (days): Mean 112

Setting: China, 2-6 months after a stroke

Notes: RANDOMISATION: no further details
n= 121

Age: Mean 64

Sex: 75 males 46 females

Diagnosis: Exclusions:
-

HDRS-17 <7

Data Used
  • ADL
  • Response (>50 reduction from baseline)
  • Remission (below cut-off)
Notes: TAKEN AT: baseline and endpoint
DROPOUR: Paroxetine: 4/64; Placebo 7/57
Group 1 N= 64 Group 2 N= 57
  • Placebo
funding: no information
Results from this paper:
Quality assessment score = +
ZHAO2005
Study Type: RCT

Study Description: Paper is a Chinese translation

Type of Analysis: completer only

Blindness: No mention

Duration (days): Mean 42

Setting: Community hospital, CHINA

Notes: RANDOMISATION: procedure not reported

Info on Screening Process: Not reported
n= 102

Age: Mean 59

Sex: 45 males 37 females

Diagnosis: Exclusions:
-

Not meeting CCMD-3 criteria for depression

-

No confirmatory CT/MRI diagnosis of stroke

-

Unable to understand questionnaires and/or unable to complete assessments

HAMD <18

Notes: Baseline and endpoint data only reported for the completer sample and not for the randomised sample.

Baseline: Not reported
Data Used
  • Response (>50 reduction from baseline)
  • Remission (below cut-off)
Data Not Used
  • Quality of life (physical) - Chinese
  • HAM-D - Chinese
Notes: TAKEN AT: baseline and endpoint
DROP OUT: Citalopram 8/50; Venlafaxine 12/52
Group 1 N= 50
  • Citalopram - Received 20mg/day of active medication which could be increased to a max of 40 mg/day after qweek 1 depending on course of illness and response
Group 2 N= 52
  • Venlafaxine - Target dose of 200mg/day (tirated over 2 days, starting from 50mg b.d.i
No details of funding reported
Results from this paper:
Quality assessment score = +

From: Appendix 18, Clinical study characteristics tables

Cover of Depression in Adults with a Chronic Physical Health Problem
Depression in Adults with a Chronic Physical Health Problem: Treatment and Management.
NICE Clinical Guidelines, No. 91.
National Collaborating Centre for Mental Health (UK).
Leicester (UK): British Psychological Society; 2010.
© NCCMH. All rights reserved.

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