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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 Eight-week randomised, double-blind multicentre study.
Participants Inpatients fulfilling DSM-IV criteria for major depression, with a score of at least 18 on the first 17 items on the HDRS-21 and a score of at least 18 on the HAM-A.
Age range: over 18 years old.
Exclusion criteria: pregnancy, lactation, absence of contraception, suicidal risk, medical disease, history of allergy to study drugs, previous participation to any antidepressant trial, history of unresponsiveness to fluoxretine or amitriptyline, organic mental disorder, substance abuse, bipolar disorder, melancholic disorder, panic or obsessive compulsive disorder, concomitant medication with psychotropic effect
Interventions Fluoxetine: 77 participants.
Amitriptyline : 80 participants.
Fluoxetine dose: 20 mg/day.
Amitriptyline dose range: 50-250 mg/day.
Outcomes Hamilton Rating Scale for Depression, HAM-A, Raskin Depression Scale, Covi Anxiety Scale, CGI-I, PGI
Notes Response: decrease of at least 50% in the total score on the HDRS and a decrease of at least 25% in the total score on the HAM-A.
Funding: by industry
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear B - Unclear