Methods | Six-week double-blind, randomised study. | |
Participants | Inpatients fulfilling DSM-III-R criteria for major depressive episode, with a score of at least 20 on the HDRS-21. Age range: 18-70 years. Exclusion criteria: psychosis, organic mental disorder, substance abuse active within 1 year |
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Interventions | Fluoxetine: 56 participants. Imipramine: 62 participants. Fluoxetine dose range: 40-80 mg/day. Imipramine dose range: 150-300 mg/day. Chloral hydrate (max 1 g) and flurazepam (max 30 mg) were allowed as hypnotic |
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Outcomes | Hamilton Rating Scale for Depression (HDRS-21), Raskin, Covi, Clinical Global Impression Severity and Improvement Scales | |
Notes | Response: decrease of at least 50% in the HAM-D total score. Remission: total score less than 7. One patient on fluoxetine committed suicide. Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |