| Methods |
Six‐week double‐blind, randomised study |
| Participants |
Outpatients fulfilling DSM‐III criteria for major depressive illness, with a score of at least 20 on the Hamilton Rating Scale for Depression (HDRS).
Age range: 20‐64 years
Exclusion criteria: concomitant physical condition or history of conditions that could interfere with therapy |
| Interventions |
Fluoxetine: 54 participants
Imipramine: 54 participants
Placebo: 57 participants
Fluoxetine dose range: 20‐80 mg/day
Imipramine dose range: 75‐300 mg/day |
| Outcomes |
HDRS, Raskin Depression Scale (RDS), Covi Anxiety Scale (CAS), Clinical Global Impression (CGI) Severity and Improvement |
| Notes |
One patient attempted suicide in the fluoxetine group
Funding: unclear |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "randomly assigned", 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 |
Quote: "double blind study. Placebo and the study drugs were supplied as identical capsules", no further 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 |
Scores reported without standard deviations. Reasons for dropout not clear. Scores reported without denominator |
| Selective reporting (reporting bias) |
Unclear risk |
Side effects reported only over 10% |
| Other bias |
Unclear risk |
Funding: unclear |
