Methods | Twelve-week double-blind randomised multicentre study | |
Participants | Outpatients meeting DSM-IV diagnostic criteria for major depression, with a minimum baseline score of 20 on the 21-item HDRS, recruited from three clinical sites. Age range: 18-65 years. Exclusion criteria: known sensitivity to venlafaxine or fluoxetine, a history of any clinically significant cardiac, hepatic or renal disease or abnormalities on a screening physical examination, ECG or laboratory tests, with any mental or neurologic disorder and breast-feeding women; used of any investigational drug, antipsychotic drug, electroconvulsive therapy or sumatriptan within 30 days of baseline, fluoxetine within 21 days and MAO-I within 14 days |
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Interventions | Fluoxetine: 47 participants. Venlafaxine: 40 participants. Fluoxetine dose range: 20-40 mg/day. Venlafaxine dose range: 75-150 mg/day. |
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Outcomes | Hamilton Rating Scale for Depression (HDRS-21), Montgomery and Asberg Scale for Depression (MADRS), Clinical Global Impression Scale | |
Notes | Patients in the fluoxetine group had more chronic histories of depression at baseline. Predominance of females in the whole study. Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |