| Methods |
Eight‐week randomised, double‐blind, 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 (HDRS‐21).
Age range: 18‐83 years
Exclusion criteria: history of clinically significant disease, abnormalities on ECG or laboratory tests, acute suicidal tendencies, history of seizure disorder, organic mental disorder, bipolar disorder or personality disorder, history of any psychotic disorder not associated with depression, venlafaxine or fluoxetine hypersensitivity or use within 2 months of baseline, current use of investigational drugs, antipsychotic drugs, ECT or MAOI within the previous 14 days, use of antidepressant drug within 7 days, use of any anxiolytic that could not be withdrawn at baseline, drug or alcohol abuse within 2 years of the start of the study. |
| Interventions |
Fluoxetine: 161 participants
Venlafaxine: 153 participants
Fluoxetine dose: 20 mg/day
Venlafaxine dose range: 75‐150 mg/day |
| Outcomes |
HDRS‐21, Montgomery and Asberg Scale for Depression (MADRS), Clinical Global Impression (CGI) scales |
| Notes |
Response: decrease of at least 50% in the HDRS or MADRS total score, or a score of 1 or 2 on the CGI
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 |
Low risk |
Scores reported with denominator. Number and reasons for withdrawals reported |
| Selective reporting (reporting bias) |
Unclear risk |
No CGI endpoint scores reported. Only most common (over 5%) side effects reported |
| Other bias |
High risk |
Quote: "this study was supported by Wyeth‐Ayerst Research" and this company produces venlafaxine |
