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. Author manuscript; available in PMC: 2014 Sep 15.
Published in final edited form as: Cochrane Database Syst Rev. 2005 Oct 19;(4):CD004185. doi: 10.1002/14651858.CD004185.pub2
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
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.
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
Notes Funding: by industry
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear B - Unclear