Methods |
Twenty‐six‐week double‐blind, randomised, multicentre study |
Participants |
Outpatients (primary care) fulfilling DSM‐IV criteria for major depressive disorder, with a score of at least 20 at Montgomery and Asberg Scale for Depression (MADRS).
Age range: 18‐65 years
Exclusion criteria: pregnancy, lactation, failure to use a safe contraceptive method; concurrent major psychiatric disorders, such as anxiety disorder, dementia, somatoform disorders, agoraphobia, social phobia, any history of schizophrenia, psychosis or personality disorder; severe concurrent medical illness; alcohol or drug dependence; serious adverse reactions related to medicines; previous treatment with antidepressant for less than 3 week; major suicide risk. |
Interventions |
Fluoxetine: 120 participants
Sertraline: 122 participants
Fluoxetine dose range: 20‐60 mg/day
Sertraline dose range: 50‐150 mg/day |
Outcomes |
MADRS and Clinical Global Impression (CGI) |
Notes |
Response: decrease of at least 50% in the MADRS total score
Funding: by industry |
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 |
Criteria and number of drop‐out reported. Rating scale reported without denominator |
Selective reporting (reporting bias) |
Unclear risk |
Scores at rating scales were reported without standard deviations. Side effects reported |
Other bias |
High risk |
Last author's affiliation was Pfizer France, Orsay. This company produces sertraline |