| Methods |
Five‐week randomised, double‐blind study |
| Participants |
Outpatients fulfilling ICD 9 criteria for major unipolar or bipolar depression, with a score of at least 17 on the HDRS, a score of at least 8 on the Raskin Depression Scale (RDS), greater than Covi Anxiety Scale (CAS) score.
Age range: 25‐63 years
Exclusion criteria: history of psychosis, suicide risk, severe mental diseases, contraindication to amitriptyline, severe organic disease, known drug allergy, use of amitriptyline within 4 weeks of baseline, use of neuroleptics within 2 weeks of study entry. |
| Interventions |
Fluoxetine: 51 participants
Amitriptyline: 51 participants
Fluoxetine dose: 20 mg/day
Amitriptyline dose: 100 mg/day
Chloral hydrate or benzodiazepines for insomnia were allowed |
| Outcomes |
Hamilton Rating Scale for Depression (HDRS‐17), Clinical Global Impression (CGI), RDS, CAS |
| Notes |
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 |
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 |
It was unclear which was the last observation carried forward (LOCF) population |
| Selective reporting (reporting bias) |
Unclear risk |
Three rating scales for depression were listed in methods, but only one was reported |
| Other bias |
Unclear risk |
Funding: unclear |
