| Methods |
Six‐week randomised, double‐blind study |
| Participants |
Outpatients fulfilling DSM‐III criteria for unipolar major depression, with a score of at least 20 on the Hamilton Rating Scale for Depression‐21 item (HDRS‐21).
Mean age: 39.9 in the fluoxetine group, 44.5 in the amitriptyline one
Exclusion criteria: significant medical illness, concomitant medication with any potential psychiatric side effect, psychotic features, any other DSM‐III Axis I diagnosis other than unipolar major depression. |
| Interventions |
Fluoxetine: 20 participants
Amitriptyline: 20 participants
Fluoxetine dose range: 20‐60 mg/day
Amitriptyline dose range: 50‐200 mg/day |
| Outcomes |
HDRS‐21, Clinical Global Impression for Severity and Improvement (CGI S‐I), Patient Global Impression (PGI) |
| Notes |
Improvement: a decrease of at least 50% on the total HDRS‐21 score
Funding: by industry |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "(patients) were randomly assigned to fluoxetine treatment", 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 |
Double‐blind, no further information |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Double‐blind, no further information |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Mean endpoint scores reported without denominators. Adverse events not clearly reported |
| Selective reporting (reporting bias) |
Unclear risk |
Mean endpoint scores and standard deviations reported (HDRS, CGI) |
| Other bias |
High risk |
Supported by Eli Lilly, and this company produces fluoxetine |
