Methods | Eight-week randomised, double-blind multicentre study. | |
Participants | Outpatients fulfilling DSM-IV criteria for current major depressive disorder, with a score of at least 20 on the HDRS-21. Age range: over 18 years old. Exclusion criteria: recent treatment within 6 months or known hypersensitivity to either study drugs, serious medical conditions, bipolar mood disorder, psychotic disorder not associated with depression, history of drug or alcohol dependence within 1 years of study entry, suicidal patients, pregnancy, lactation |
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Interventions | Fluoxetine: 103 participants. Venlafaxine: 100 participants. Venlafaxine: 100 participants. Placebo: 98 participants. Fluoxetine dose range: 20-60 mg/day. Venlafaxine dose range: 75-250 mg/day. Chloral hydrate was allowed as hypnotic. |
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Outcomes | Primary outcomes: Hamilton Rating Scale for Depression (HDRS-21) total score and depressed mood items, MADRS total score, CGI. Secondary outcome: Hamilton Rating Scale for Anxiety. |
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Notes | Response: decrease of at least 50% in the total score from baseline on HDRS and MDRS or a CGi score of 1 or 2. Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |