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 HDRS-21. Age range: 18-83. 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or MAOI within the previous 14 days, use of antidepressant drug within 7 days, use of any anxiolitic that could not be withdrawn at baseline, drug or alcolhol abuse within 2 years of the start of the study |
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Interventions | Fluoxetine: 161 participants. Venlafaxine: 153 participants. Fluoxetine dose: 20 mg/day. Venlafaxine dose range: 75-150 mg/day. |
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Outcomes | Primary outcomes: Hamilton Rating Scale for Depression (HDRS-21), Montgomery and Asberg Scale for Depression (MADRS), CGI scales | |
Notes | Response: decrease of at least 50% in the HAM-D or MADRS total score, or a score of 1 or 2 on the CGI. Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |