Methods |
Twelve‐week double‐blind, randomised, multicentre study |
Participants |
Patients fulfilling DSM‐III‐R criteria for major depression (single or recurrent), with a score of at least 20 on the Montgomery and Asberg Scale for Depression (MADRS).
Age range: 18‐70 years
Exclusion criteria: not stated |
Interventions |
Fluoxetine: 82 participants
Amineptine: 87 participants
Fluoxetine dose: 20 mg/day
Amineptine dose: 200 mg/day
Anxiolitics and non‐barbiturate hypnotics were allowed |
Outcomes |
MADRS, Clinical Global Impression (CGI), Mood Anxiety Retardation and Danger (MARD) |
Notes |
Funding: unclear |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Quote: "random allocation". 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 |
Number and reasons of attrition not clear. Ratings scores reported without denominator |
Selective reporting (reporting bias) |
Unclear risk |
Data at follow‐up not reported. Adverse effects not reported |
Other bias |
Unclear risk |
Funding: unclear |