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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 double-blind, randomised, multicentre study.
Participants Patients fulfilling DSM-III criteria for major depressive disorder, with a score of at least 20 on HDRS-21.
Age range: not stated.
Exclusion criteria: significant concurrent illness including renal, hepatic, cardiovascular or neurological disease, non-stabilised diabetes, other current Axis I psychiatric diagnosis; organic brain syndrome, past or present abuse of alcohol or drugs; pregnancy or lactating; ECT; continuous lithium therapy in preceeding 2 months, use of important psychotropic drug, current therapy with an anticoagulant or type 1 antiarrhytmic
Interventions Fluoxetine: 101 participants.
Paroxetine: 102 participants.
Fluoxetine dose range: 20-80 mg/day.
Paroxetine dose range: 20-50 mg/day.
Chloral hydrate was allowed just during the first two weeks of the study
Outcomes Primary outcome: Hamilton Rating Scale for Depression (HDRS-21), Clinical Global Impression.
Secondary outcomes: HAM- anxiety and somatisation scores.
Notes Response: decrease of at least 50% in the HAM-D total score and/or a total score less than 10.
Two participants dropped out (1 in the fluoxetineand 1 in the paroxetine group) due to attempted suicide.
Funding: by industry
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear B - Unclear