| Methods |
Twelve‐week randomised, double‐blind multicentre study |
| Participants |
Outpatients (general practice) fulfilling DSM‐IV criteria for major depressive disorder, with a score of at least 19 on the Montgomery–Åsberg Depression Rating Scale (MADRS).
Age: over 18 years
Exclusion criteria: use of study drugs within 1 month of entry, psychosis, organic mental disorder, bipolar depression, acute suicidal risk, use of psychoactive drug or ECT within 1 month of entry, drug or alcohol dependence, history of clinically significant physical disorder, clinically significant abnormalities (ECG, laboratory test), pregnancy, lactation. |
| Interventions |
Fluoxetine: 170 participants
Venlafaxine: 171 participants
Fluoxetine dose: 20 mg/day
Venlafaxine dose: 75 mg/day |
| Outcomes |
Primary outcome: endpoint score on MADRS and Clinical Global Impression (CGI), and Hamilton Rating Scale for Depression (HDRS)
Secondary outcomes: Hospital Anxiety and Depression Scale (HADS) |
| Notes |
Response: decrease of at least 50% in the total score on the HDRS or MADRS and a CGI Improvement of 1 or 2
Funding: by industry |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "eligible patients were randomised by the permuted blocks method", 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: "identical capsules" and "In order to maintain blinding, a matched placebo was taken in the evening by patients randomised to received fluoxetine", 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 for discontinuation reported. Denominator reported for responders was different from the number of randomised patients |
| Selective reporting (reporting bias) |
High risk |
Adverse events reported only if they occurred in at least 5% of the sample. Endpoint scores reported without standard deviations |
| Other bias |
High risk |
Quote: "this study was funded by Wyeth Laboratories Ltd." This company produces venlafaxine |
