| Methods |
Eight‐week double‐blind, randomised, multicentre study |
| Participants |
Outpatients fulfilling DSM‐III‐R criteria for major depression, with a score of at least 20 on the Hamilton Rating Scale for Depression‐21 item (HDRS‐21) and depressive symptoms for at least 1 month before study entry.
Age range: 18‐60 years
Exclusion criteria: pregnancy, absence of methods of contraception, known sensitivity to fluoxetine or venlafaxine, history of significant cardiac, renal or hepatic disease, clinically significant abnormalities on a screening examination, ECG, laboratory tests, acute suicide tendency, seizures, history or presence of any psychotic disorder not associated with depression, drug or alcohol dependence within the past year, psychotherapy, use of fluoxetine, antipsychotic drugs, ECT, MAOI within the past 14 days, any other antidepressant, anxiolitics, sedative‐hypnotic drugs (but zopiclone) within 7 days before baseline. |
| Interventions |
Fluoxetine: 186 participants
Venlafaxine: 196 participants
Fluoxetine dose range: 20‐40 mg/day
Venlafaxine dose range: 75‐125 mg/day |
| Outcomes |
Primary outcomes: HDRS‐21, Montgomery and Asberg Scale for Depression (MADRS), Clinical Global Impression (CGI) Severity and Improvement |
| Notes |
Response: decrease of at least 50% in the HDRS or in the MADRS; or a CGI‐I score of 1 or 2
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 other information |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Double blind, no other information |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Unclear if raters were independent and unclear if blinding was successful |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Rating scale scores reported without denominator |
| Selective reporting (reporting bias) |
Unclear risk |
Mean scores reported without standard deviations. Side effects reported only if they occurred at least in 5% of the patients |
| Other bias |
High risk |
Quote: "supported by a grant from Wyeth‐AYerst International". This company produces venlafaxine |
