Methods | Six-week randomised, double-blind, multicentre study. | |
Participants | Outpatients fulfilling DSM-III-R criteria for major depressive disorder, with a score of at least 18 on the first 17 items of the HDRS-21. Age range: 18-64 years old. Exclusion criteria: marked suicide risk, major depressive episode associated with moo-incongruent psychotic features, bipolar disorder, acute confusional state, epileptic or seizure disorder, mental retardation, history of unstable diabetes or clinically significant physical disease, known sensitivity to moclobemide, MAOI, fluoxetine or other SSRIs, history of alcohol or subtance abuse within the last 6 months, treatment with MAOI within the past 2 weeks, fluoxetine within the past 5 weeks, try- or heterocyclics antidepressants or lithium or daytime benzodiazepines within the past week, ECT within the past 3 months, concomitant use of medication known to affect the action of moclobemide or fluoxetine, use of any investigational drug within the past 3 months, pregnancy, lactation, absence of contraception |
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Interventions | Fluoxetine: 62 participants. Moclobemide: 66 participants. Fluoxetine dose range: 20-40 mg/day. Moclobemide dose range: 200-600 mg/day. |
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Outcomes | Primary outcomes: Hamilton Rating Scale for Depression (HDRS-21). Secondary outcomes: Montgomery and Asberg Scale for Depression (MADRS), CGI, SCL-58 |
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Notes | Response: decrease of at least 50% in the MADRS total score and a total score of less than 10. Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |