Methods | Twelve-week randomised, double-blind study. | |
Participants | Outpatients fulfilling DSM-III-R criteria for major depressive episode (single or recurrent), without psychotic features, with a score of at least 18 on the HDRS-24. Age range: over 60 years old. Exclusion criteria: DSM-III-R criteria for any other psychiatric disorder, significant cognitive impairment (MMSE less than 24), any medical controindication to any antidepressant theraphy, endocrine, cardiovascular, gastrointestinal, renal disease, failure to responde to ECT in a prior depressive episode or to adequate trials (6 weeks) of 2 or more antidepressants |
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Interventions | Fluoxetine: 119 participants. Sertraline: 117 participants. Fluoxetine dose range: 20-40 mg/day. Sertraline dose range: 50-100 mg/day. Temazepam and chloral hydrate were allowed for sleep. |
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Outcomes | Primary outcome: Hamilton Rating Scale for Depression (HDRS-24) (total and factor scores), CGI-S, CGI-I, CGI-Efficay iIndex rating. Secondary outcomes: Montgomery and Asberg Scale for Depression, Hamilton Rating Scale for Anxiety, POMS, Beck Depression Inventory, Q-LES-Q |
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Notes | Funding: by industry | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |