Methods | Twelve-week randomised, double-blind multicentre study. | |
Participants | Outpatients (general practice) DSM-III-R criteria for major unipolar depression, with a score of at least 12 on the HDRS. Age range: 18-70 years old. Exclusion criteris: suicidal ideation, history of treatment resistan depression, bipolar disorder, organic brain disease, substance use disorder, use of antidepressants within the last 6 months, partecipation to another study within 3 months, medical controindication to either drug, pregnancy, lactation, absence of contraception, administration of any other psychotropic medication |
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Interventions | Fluoxetine: 76 participants. Dothiepin: 76 participants. Fluoxetine dose: 20 mg/day. Dothiepine dose range: 75-150 mg/day. Concomitant use of benzodiazepines was allowed for insomnia. |
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Outcomes | Primary outcomes (all were dichotomised as above or below 80% of full compliance): pill count, patient completed questionnaire, Medication Event Monitoring System. Secondary outcomes: Hamilton Rating Scale for Depression, Short-Form Health Survey Questionnaire 36 |
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Notes | Funding: by industry | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |