| Methods |
Six‐week randomised, double‐blind, two‐centre study |
| Participants |
In‐ and outpatients fulfilling Research Diagnostic Criteria for major depressive disorder, with a score of at least 17 on the Hamilton Rating Scale for Depression (HDRS).
Mean age: 46.1 (fluoxetine) and 45.4 (imipramine) years
Exclusion criteria: significant physical illness, history of drug abuse, schizophrenia, duration of illness more than 1 year. |
| Interventions |
Fluoxetine: 30 participants
Imipramine: 30 participants
Fluoxetine dose range: 40‐60 mg/day
Imipramine dose range: 75‐150 mg/day
Only temazepam was allowed for night sedation |
| Outcomes |
HDRS, Montgomery and Asberg Scale for Depression (MADRS) |
| Notes |
Funding: unclear |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "randomly allocated", no other information |
| Allocation concealment (selection bias) |
Unclear risk |
No information provided |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Double blind, no other information |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Double blind, no other information |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Double blind, no other information |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Denominator reported for responders was different from the number of randomised number. Number and reasons for withdrawals not clearly reported |
| Selective reporting (reporting bias) |
Unclear risk |
Mean scores reported without standard deviations. Side effects not clearly reported |
| Other bias |
Unclear risk |
Funding: unclear |
