| Methods |
Eight‐week 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).
Age range: 18‐55 years
Exclusion criteria: lactation, childbearing potential, previous treatment with venlafaxine or fluoxetine, history of clinically significant medical disease, abnormalities on ECG or laboratory tests, acute suicidal tendencies, history of seizure disorder, organic mental disorder, bipolar disorder, history of any psychotic disorder not associated with depression, current use of investigational drugs, antipsychotic drugs, ECT within the previous 30 days or MAOI or paroxetine within the previous 14 days, use of antidepressant or hypnotic drugs, but zopiclone (7.5 mg), history of drug or alcohol abuse. |
| Interventions |
Fluoxetine: 75 participants
Venlafaxine: 70 participants
Fluoxetine dose range: 20‐40 mg/day
Venlafaxine dose range: 75‐150 mg/day
Only zopiclone was allowed for insomnia |
| Outcomes |
HDRS‐21, Montgomery and Asberg Scale for Depression (MADRS), Clinical Global Impression, Symptom Checklist 61 Item (SCL‐61) |
| Notes |
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 |
High risk |
Quote: "Open‐label" |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Quote: "Open‐label" |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Quote: "Open‐label" |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Rating scale scores reported without denominator. Number and reasons for withdrawal reported |
| Selective reporting (reporting bias) |
Unclear risk |
Mean scores reported without standard deviations. Adverse events reported over 5% |
| Other bias |
High risk |
Quote: "this study was supported by Wyeth‐Ayerst International, Saint David's, Pennsylvania": Tihs company produces venlafaxine |
