Methods | Eight-week double-blind, multicentre study. | |
Participants | Outpatients suffering from a major depressive episode according to DSM-III-R, with a baseline score on HDRS-17 of at least 18, recruited from nine separated psychiatric clinics. Age range: 18 years or more. Exclusion criteria: depression secondary to other conditions, concomitant illness of renal, cardiac or hepatic origin; hypersensitivity to other antidepressants, likelihood of poor compliance, risk of suicide, peptic ulcer history, an improvement of greater than 25% in the HDRS score during a pre-treatment placebo washout period |
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Interventions | Fluoxetine: 56 participants. Sertraline: 52 participants. Fluoxetine dose range: 20-60 mg/day. Sertraline dose range: 50-150 mg/day. Benzodiazepines were allowed for hypnotic use and as maintenance treatment for pre-existing anxiety |
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Outcomes | Hamilton Rating Scale for Depression (HDRS) and for Anxiety (HAM-A), Montgomery and Asberg Scale for Depression (MADRS), Zung Self-Rating Scale for Anxiety, Leeds Sleep Evaluation Questionnaire, Clinical Global Impression Scale, including severity (CGI-S) and improvement (CGI-I) | |
Notes | 75% of the patients were women. Higher percentage of patients with a family history of psychiatric illness in the fluoxetine group. Higher percentage of patients with severe depression in the fluoxetine group (30.4%) than in the sertraline group (13.7%). Funding: unclear |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |