| Methods |
Six‐week randomised, double‐blind study |
| Participants |
Inpatients fulfilling Research Diagnostic Criteria for major depressive disorder, with a score of at least 17 on the Hamilton Rating Scale for Depression (HDRS).
Age range: 18‐64 years
Exclusion criteria: concurrent medical disorder |
| Interventions |
Fluoxetine: 16 participants
Amitriptyline: 18 participants
Fluoxetine dose range: 40‐60 mg/day
Amitriptyline dose range: 100‐150 mg/day
Only oxazepam (max 100 mg/day) was allowed |
| Outcomes |
HDRS, Montgomery and Asberg Scale for Depression (MADRS), Clinical Global Impression (CGI) Severity and Improvement, Patient Global Impression (PGI) |
| Notes |
Funding: by industry |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "randomly allocated, according to predetermined schedule", 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 |
High risk |
Denominator reported for responders was different from the number of randomised patients. Reasons for withdrawal were not reported |
| Selective reporting (reporting bias) |
Unclear risk |
Adverse events were reported. Mean scores were reported with standard deviations |
| Other bias |
High risk |
Last author's affiliation was Eli Lilly Benelux and this company produces fluoxetine |
