Methods | Six-week double-blind, randomised multicentre study. | |
Participants | Outpatients with a diagnosis of major depression or bipolar disorder, depressed, according to DSM-III-R, scoring at least 18 on the HDRS-17 and with a higher on the Raskin Depression Scale than on the Covi Anxiety Scale. Age range: over 18 years old. Exclusion criteria: pregnant or lactating women, women of childbearing potential not practicing a reliable method of contraception, patients whit previous treatment with sertraline or fluoxetine, treated with MAOI within two weeks or other antidepressants medication within one week of double-blind therapy, treated with reserpine or methyl-dopa, likely to require additional treatments with psychoactive medication, ECT or intensive psychotherapy during the study.; failure to respond to previous antidepressant therapy at clinically appropriate dosages, use of ECT to treat a previous episode of depression, a history of severe allergies or multiple adverse events associated with pharmacotherapy, the presence of significant medical disease; psychioatric history including another Axis I disorder and significant suicide risk |
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Interventions | Fluoxetine: 144 participants. Sertraline: 142 participants. Fluoxetine dose range: 20-40 mg/day. Sertraline dose range: 50-100 mg/day. Chloral hydrate (max 1 g) and temazepam (max 20 mg) were allowed as hypnotic |
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Outcomes | Primary outcome: Hamilton Rating Scale for Depression (HDRS-17), Clinical Global Impression Severity and Improvement Scales. Secondary outcomes: Hamilton Rating Scale for Anxiety, the Raskin Depression Scale and Covi Anxiety Scale, self-rated Leeds Sleep Questionnaire |
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Notes | Patients with concomitant medical condiztions were allowed to participate in the study provided that the conditions were clearly not associated with the illness of the study and that any required medications were not psychoactive agents. One attempted suicide in the fluoxetine group. Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |