| Methods |
Five‐week randomised, double‐blind study |
| Participants |
Outpatients fulfilling Research Diagnostic Criteria criteria for unipolar major depression, with a score of at least 20 on the Hamilton Rating Scale for Depression (HDRS) and Raskin Depression Scale (RDS) score of at least 8.
Age range: 19‐69 years
Exclusion criteria: serious illness or condition that contraindicated the use of amitriptyline or that could make patients unsuitable for study. |
| Interventions |
Fluoxetine: 22 participants
Amitriptyline: 22 participants
Fluoxetine dose range: 20‐80 mg/day
Amitriptyline dose range: 75‐300 mg/day
Only chloral hydrate (max 1 g) was allowed for sleep and one benzodiazepine for agitation |
| Outcomes |
HDRS, RAS, Covi Anxiety Scale (CAS), Clinical Global Impression (CGI) |
| 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 |
Quote: "to ensure the double blind, study drugs were divided into daytime and bedtime doses", 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 score and standard deviation at CGI not reported. Number and reasons for discontinuation reported |
| Selective reporting (reporting bias) |
Unclear risk |
Mean endpoint scores (HDRS, RDS, CAS) reported without standard deviations. Side effects reported |
| Other bias |
Unclear risk |
Funding: unclear |
