Table 31Efficacy of pharmacotherapy versus control, augmenting strategies

Author, year
Endpoint
Current Episode Failure Requirement
Quality
Intervention and Sample Size
Study Details
Population CharacteristicsChange in Depressive SymptomsResponse
Remission
Berman et al., 2007113
6 weeks, mITT
Required failure in the current episode
Fair
ARI (n = 184)
Placebo (n = 178)
Treatment strategy
ARI: Augmentation
Placebo: Maintenance
All patients receiving ESC, FLU, PAR, SER, VEN at maximum tolerated dose; ARI (2-20 mg/day)
Definitions
Remission defined as MADRS < 10 and ≥ 50% decrease in score
Baseline Depression
MADRS, mean (SD)
ARI: 26.0 (6.1)
Placebo: 25.9 (6.5)
MADRS
Change*, mean (SD)
ARI: -8.8
Placebo: -5.8
P < 0.001
*mITT
ARI N = 181
Placebo: 172
MADRS
Response, n (%)
ARI: 61 (33.2)
Placebo: 41 (23.0)
* P ≤ 0.05
Remission, n (%)
ARI: 47 (25.5)
Placebo: 27 (15.2)
* P ≤ 0.01
Berman et al., 2009114
6 weeks, mITT
Required failure in the current episode
Fair
ARI (n = 177)
Placebo (n = 172)
Same antidepressant medications as above
Treatment strategy
ARI: Augmentation
Placebo: Maintenance
All patients receiving ESC, FLU, PAR, SER, VEN
at maximum tolerated dose; ARI (2-20 mg/day)
Definitions
Remission defined as MADRS < 10 and ≥ 50% decrease in score
Baseline Depression
MADRS, mean (SD)
ARI: 26.6 (5.8)
Placebo: 27.1 (5.8)
MADRS
Change*, mean (SD)
ARI: -10.1
Placebo: -6.4
P < 0.001
*mITT
ARI: N = 174
Placebo: N = 169
MADRS
Response, n (%)
ARI: 81 (45.8)
Placebo: 45 (26.2)
* P ≤ 0.001
Remission, n
ARI: 64 (36.2)
Placebo: 32 (18.6)
*P ≤ 0.001
Nierenberg et al., 2003109
6 weeks
Required failure in the current episode
Fair
LITH Augmentation (n = 18)
Dosing strategy NR
Placebo (n = 17)
All patients continued nortriptyline
Treatment strategy
LITH: Augmentation
Placebo: Maintain
Baseline Depression
HAM-D21, mean (SD)
LITH: 18.8
Placebo: 19.8
HAM-D21
Change, mean (SD)
LITH: -2.9
Placebo: -3.6
P = NR
HAM-D21
Response, n (%)
LITH: 2 (11.1)
Placebo: 3 (17.6)
P = NS
Shelton et al., 2001110
8 weeks
Required failure in the current episode
Fair
OLA+ Placebo (n = 8)
5-20 mg/d
FLU+ Placebo (n = 10)
20-60 mg/d
OLA+FLU (n = 10) same dose as above
Treatment strategy
OLA+PLA: Not of interest
FLU+PLA: Maintain
OLA: Augmentation
Baseline Depression
MADRS: NR
MADRS
Change, mean (SD)
OLA+ Placebo: -2.8
FLU+ Placebo: -1.2
OLA+FLU:-13.6
MADRS
Response, n (%)
OLA+ Placebo: 0 (0)
FLU+ Placebo: 1 (10)
OLA+FLU: 6 (60)
OLA-FLU versus OLA+ Placebo, P = 0.03
OLA+FLU versus FLU+ Placebo, P = 0.11
Thase et al., 2007111
8 weeks
Required failure in the current episode
Fair
OLA+FLU (n = 200)
OLA 6, 12, or 18 mg/day plus 50 mg/day FLU
OLA (n = 206)
6, 12, or 18 mg/day
FLU (n = 200)
50 mg/day
Treatment strategy
OLA-FLU: Augmentation
OLA: Not of interest (Switch)
FLU: Maintain
Baseline Depression
MADRS, mean (SD)
OLA+FLU: 30.0 (6.7)
OLA: 29.9 (6.4)
FLU: 29.9 (6.7)
MADRS
Change, mean (SD)
OLA+FLU: -12.6 (10.3)
OLA: -9.2 (9.7)
FLU: -8.9 (9.0)
OLA+FLU versus OLA, P < 0.001
OLA+FLU versus FLU, P < 0.001
MADRS
Response, n (%)
OLA+FLU: 80 (40.4)
OLA: 60 (29.6)
FLU: 51 (25.9)
OLA+FLU versus FLU, P = 0.028
OLA+FLU versus FLU, P = 0.003
Remission, n (%)
OLA+FLU: 54 (27.3)
OLA: 34 (16.7)
FLU: 29 (14.7)
OLA+FLU versusFLU, P = 0.012
OLA-FLU versus FLU, P = 0.003

ARI = aripriprazole; ESC = escitalopram; FLU = fluoxetine; HAM-D21 = 21-item Hamilton Depression Scale; LITH = lithium, n = number; MADRS = Montgomery-Asberg Depression Rating Scale; mg/d = milligrams per day; mITT = modified intention to treat; NR = not reported; NS = not significant; OLA = olanzapine; OLA-FLU = olanzapine+fluoxetine; OLA+PLA = olanzapine plus placebo; PAR = paroxetine; SD = standard deviation; SER = sertraline; VEN = venlafaxine

From: Results

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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