Methods | Six-week double-blind, randomised study. | |
Participants | Outpatients satisfying the DSM criteria for bipolar disorder, fulfilling DSM-III criteria for major depressive disorder, with a score of at least 20 on the HDRS-21 and at least 8 on the Raskin Scale. Age range: 18-70 years. Exclusion criteria: serious physocal illness, chronic or acute organic brain symptoms, epilepsy, alcoholism, drug addiction |
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Interventions | Fluoxetine: 30 participants. Imipramine: 30 participants. Placebo: 29 participants. Fluoxetine dose range: 20-80 Imipramine dose range: 75-300. The only allowed concomitant psychotropic drugs were lithium and chloral hydrate (max 1 g) |
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Outcomes | Hamilton Rating Scale for Depression, Raskin Depression Scale, Covi Anxiety Scale, CGI-Severity, CGI-Global Improvement, PGI | |
Notes | Response: decrease of at least 50% in the HAM-D. Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |