Evidence Table 33KQ 4. Adherence: Tier 1 (ECT vs. pharma—MDD/Bipolar)

Study Citation, Country, Setting
Funding, Research Objective
Study Design
N
Duration
Comparison
Study Sample
Inclusion, Exclusion Criteria
Baseline CharacteristicsRemission/ResponseQuality of Life
Adverse Events
Attrition
Author, Year
Folkerts et al., 199742

Country, setting
Germany, single center, inpatients

Funding
Not reported

Research Objective To compare ECT in a controlled, randomized study withserotonin reuptake inhibitor paroxetine in treatment-resistant depression.

Quality Rating
Fair
Study design
RCT

Type of analysis
per protocol

N
39

Duration
Total 6 weeks; Washout >= 3days; Phase I ECT - 2wks, Paroxetine - 4 wks; Phase II Paroxetine group - if clinical improvement reduction < 50% treatment switched to ECT, ECT group crossed over to Paroxetine or other antidepressants.

Interventions
G1: ECT
G2: Paroxetine

Medications Allowed
After med wash -out patients were allowed a tranquillizer (diazepam up to 5 mg daily), a sedative (lormetazepam 0.5- 1.0 mg or triazolam 0.25 mg) or a sedative neuroleptic (pipamperon, up to 40 mg daily).

Parameters
ECT:
  • % receiving bilateral: 0
  • Intensity: 2.5-fold seizure threshold
  • Number of sessions (range, mean, SD): 3/wk, range 6 to 9, mean 7.2 session
Paroxetine
  • Started at 20 mg/day, within 7 days increased to 40 mg, allowed up to 50 mg, mean dose 44 mg/day for at least 4 weeks
Strategy
Switch
TRD definition
  • 2+ failed treatmentd (8+ weeks) including at least 1 tricyclic, at a dosage of at least 100 imiprimine equivalents
  • Not required or not specified to be in current episode
Tier 1

Inclusion criteria
  • Major depressive episode single and recurrent
  • Bipolar disorders
  • HAM-D21 >=22
Exclusion criteria
  • Psychosis
  • Pronounced suicidal tendency
  • Severe physical illness
  • History of substance abuse
  • previous paroxetine or ECT treatment
Treatment Failure
Level of tx resistance (Kuhs, 1995)
G1: 1.9 (0.7 SD)
G2: 2.0 (0.8 SD)

Mean failed trials
G1: 4.9
G2: 4.3

Polarity, %
Unipolar
G1: 90.5
G2: 83.3

Bipolar
G1: 9.5
G2: 16.7

Age, mean yrs
G1: 47.6
G2: 52.3

Sex, % females
G1: 62
G2: 44

HAM-D 21
Baseline n
G1: 21
G2: 18

Baseline score, mean (SD)
G1: 31.1 (4.9)
G2: 32.6 (5.4)
HAM-D 21
Endpoint score, mean (SD)
Endof Phase I
(ECT: 2-3 wks, Paroxetine: 4 wks)
G1: 12.5 (3.9)
G2: 23.0 (10.4)
Endof Phase II (open trial, 6 weeks)
G1: 12.8 (5.1)
G2: 15.2 (7.9)

Change, mean (SD)
End of Phase I
G1: -18.6
G2: -9.6
% Reduction in HAM-D, P = 0.001
End of Phase II
G1: 18.3
G2: 17.4

Responders, n
End of Phase I
G1: 15 (71.4%)
G2: 5 (27.8%)
P = 0.006
Quality of Life
NR

Adverse Events
NR

Attrition
Overall, %
0 - all patients continued toscheduled end of treatment

At end of treatment, %
0

At end of follow-up, %
0

Withdrawals due to efficacy, %
0

Withdrawals due to adverse events, %
0

Adherence/ compliance
  • All pts continued their respective therapsies through scheduled end of treatment Phase I
  • 11 of 21 ECT were able to discontinue after 6th ECT session and 10 pts. had 3 additional ECT treatments.
  • Phase II - of ECT group, 9 received paroxetine and 12 received other antidepressants
  • Of paroxetine groups, 7 crossed over to ECT
  • 11 received antidepressants - 7 paroxetine and 4 received other antidepressants
1 person was excluded from analysis due to failure to increase treatment dosage

From: Appendix D, Evidence Tables

Cover of Nonpharmacologic Interventions for Treatment-Resistant Depression in Adults
Nonpharmacologic Interventions for Treatment-Resistant Depression in Adults [Internet].
Comparative Effectiveness Reviews, No. 33.
Gaynes BN, Lux LJ, Lloyd SW, et al.

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