Methods |
Imipramine vs placebo
randomised controlled trial (RCT) in eight primary care practices in Netherlands |
Participants |
N = 63. Imipramine group n=32; Placebo group n=31. Inclusion criteria: Age 18‐65 years. DSM‐III‐R/DSM‐IV diagnosis of current depressive disorder. Equal or greater than 18 on 17‐item Hamilton Rating Scale for Depression (HAMD) and a score of equal or greater than 4 on Clinical Global Impression scale (CGI) Exclusion criteria: on psychotropics or major medical disorder. |
Interventions |
50 mg Imipramine per day increasing to over 200 mg per day after 1 week. Duration 6 weeks with a subsample going to 18 weeks. |
Outcomes |
10 withdrew due to adverse effects: 6 on Imipramine and 4 on placebo. Results at 6 weeks: Imipramine group n=23, HAMD mean=8.9 (SD 6.2), Placebo n=26, HAMD mean=12.5 (SD 6.3) |
Notes |
Not clear who administered medication and outcome check list |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |