Methods | Eight-week randomised, double-blind multicentre study. | |
Participants | Inpatients fulfilling DSM-IV criteria for major depression, with a score of at least 18 on the first 17 items on the HDRS-21 and a score of at least 18 on the HAM-A. Age range: over 18 years old. Exclusion criteria: pregnancy, lactation, absence of contraception, suicidal risk, medical disease, history of allergy to study drugs, previous participation to any antidepressant trial, history of unresponsiveness to fluoxretine or amitriptyline, organic mental disorder, substance abuse, bipolar disorder, melancholic disorder, panic or obsessive compulsive disorder, concomitant medication with psychotropic effect |
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Interventions | Fluoxetine: 77 participants. Amitriptyline : 80 participants. Fluoxetine dose: 20 mg/day. Amitriptyline dose range: 50-250 mg/day. |
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Outcomes | Hamilton Rating Scale for Depression, HAM-A, Raskin Depression Scale, Covi Anxiety Scale, CGI-I, PGI | |
Notes | Response: decrease of at least 50% in the total score on the HDRS and a decrease of at least 25% in the total score on the HAM-A. Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |