Methods | Twelve-week randomised, double-blind, multicentre study. | |
Participants | Inpatients fulfilling DSM-III-R criteria for major depression for less than 3 months, with a score of at least 22 on the HDRS-17. Age range: 18-70 years old. Exclusion criteria: serious or uncontrolled medical illness, no remission between episodes, depression with psychotic features, dysthymia, personality disorder, lack of response to antidepressants, ECT or neuroleptics, major risk of suicide, schizophrenia and dependence of psychoactive substances (DSM-III-R) during the previous six months, use of MAOI in the previous 2 weeks, fluoxetine in the previous 4 weeks, long-acting neuleptics or ECT in the previous 3 months, pregnancy, lactation, not use of contraception |
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Interventions | Fluoxetine: 100 participants. Milnacipram (100 mg group): 100 participants. Milnacipram (200 mg group): 100 participants. Fluoxetine dose: 20 mg/day. Only oxazepam (max 50 mg/day) or chloral hydrate (max 2 g/day) as hypnotic or anxiolitic were allowed |
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Outcomes | Primary outcomes: change in the total score on the Hamilton Rating Scale for Depression (HDRS-17). Secondary outcomes: change in the total score Montgomery and Asberg Scale for Depression (MADRS), CGI |
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Notes | Response: decrease of at least 50% in the MADRS and HDRS-17 total. Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |