| Methods |
Six‐week randomised, double‐blind multicentre study |
| Participants |
Outpatients fulfilling RDC criteria for moderate‐severe major depression, with a score of at least 18 on the Hamilton Rating Scale for Depression (HDRS).
Age: 20‐65 years
Exclusion criteria: schizophrenia, organic features, use of antidepressant drugs or ECT during the 4 weeks before. |
| Interventions |
Fluoxetine: 25 participants
Amitriptyline: 25 participants
Fluoxetine dose range: 40‐80 mg/day
Amitriptyline dose range: 50‐150 mg/day |
| Outcomes |
HDRS, Hamilton Rating Scale for Anxiety (HAM‐A), Beck Depression Inventory Scale (BDI) |
| Notes |
Most patients taking sedatives during study
Funding: unclear |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomised, no further information |
| Allocation concealment (selection bias) |
Unclear risk |
No information provided |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Double blind, no further information |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Quote: "both drugs and placebo were identically formulated", no further information |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Quote: " an independent assessor scored the patients", no further information |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Number and reasons for dropout reported, but not included in the analysis |
| Selective reporting (reporting bias) |
High risk |
Only most common side effects were reported. Endpoint scores (HRSD, HAM‐A) not reported |
| Other bias |
Unclear risk |
Funding: unclear |
