Methods | Eight-week randomised, double-blind multicentre study. | |
Participants | Outpatients fulfilling DSM-III criteria for moderate to severe major depressive disorder, non psychotic, with a score of at least 18 on the first 17 items of the HDRS-17. Age range: 19-55 years old. Exclusion criteria: engaged in a shiftwork, independent sleep/wake disorders, significant concurrent general medical conditions, DSM-III criteria for psychoactive use disorder within 1 year prior to study, other major lifetime Axis I disorders (organic mental syndrome, bipolar, any psychotic, any eating, panic or obsessive-compulsive disorder), pregnancy, lactation, absence of contraception |
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Interventions | Fluoxetine: 61 participants. Nefazodone: 64 participants. Fluoxetine dose range: 20-40 mg/day. Nefazodone dose range: 200-500 mg/day. |
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Outcomes | Hamilton Rating Scale for Depression (HDRS-17) total score, IDS-C, IDS-SR, CGI Improvement Notes Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |