| Methods |
Five‐week randomised, double‐blind study |
| Participants |
Outpatients with depressive syndrome with a score of at least 17 on the Hamilton Rating Scale for Depression (HDRS) and 8 on the Raskin Depression Scale (RDS).
Age range: 19‐74 years
Exclusion criteria: severe organic illness, evidence of psychosis, psychopathic disorder, addictive illness, suicide tendencies, a period of less than 4 weeks since the last treatment with amitriptyline or neuroleptics. |
| Interventions |
Fluoxetine: 63 participants
Amitriptyline : 65 participants
Fluoxetine dose range: 20‐60 mg/day
Amitriptyline dose range: 50‐150 mg/day
Chloral derivative was allowed (eventually changed in flurazepam or nitrazepam only if its effects was inadequate) |
| Outcomes |
HDRS, Clinical Global Impression (CGI), RDS , Covi Anxiety Scale (CAS), Patient Global Impression (PGI) |
| 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: "four identical capsules were given" |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Double blind, no further information |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Rating scale scores reported without denominators. Reasons for withdrawals not clearly described |
| Selective reporting (reporting bias) |
Unclear risk |
Endpoint scores reported without standard deviations. Side effects partially reported |
| Other bias |
Unclear risk |
Funding: unclear |
