| Methods |
Design: five group parallel trial
Purpose: examine the effect of psychotherapy, imipramine and placebo on relapse of depression |
| Participants |
Patients: stable out‐patients with unipolar depression having improved markedly after imipramine medication and psychotherapy
Baseline comparability: yes |
| Interventions |
Placebo: continuous treatment with
‐tablets containing no imipramine (content NS) plus psychotherapy sessions
‐tablets containing no imipramine (content NS) plus visits to a medication clinic
Untreated: continuous treatment with psychotherapy but without any tablets
Experimental: continuous treatment with
‐imipramine tablets and psychotherapy sessions
‐imipramine tablets and visits to a medication clinic
‐continuous treatment with imipramine tablets without psychotherapy sessions
(Co‐intervention: NS) |
| Outcomes |
Number of patients with relapse of depression
Time to recurrence of depression |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'...both the patients and the members of their treatment team remained blind to whether they were receiving active medication or placebo' |
| Blinding?
Outcome assessor |
Low risk |
Partly blinded |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
Low risk |
N = 52 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly concealed |
