Duloxetine in the prevention of depressive recurrences: a randomized, double-blind, placebo-controlled trial.
OBJECTIVE
To assess the efficacy of duloxetine 60-120 mg once daily in the prevention of depressive recurrence in outpatients with recurrent major depressive disorder (MDD).


METHODS
Eligible patients with at least 3 episodes of MDD (DSM-IV diagnosis) in the past 5 years received open-label duloxetine 60-120 mg/day for up to 34 weeks. Patients meeting response criteria were then randomly assigned to either duloxetine or placebo for up to 52 weeks of double-blind maintenance treatment. The primary outcome measure was time to recurrence of a major depressive episode. Safety and tolerability were assessed via analysis of treatment-emergent adverse events (TEAEs), vital signs, weight, and laboratory measures. Patients were recruited from 43 study centers in 5 European countries (France, Germany, Italy, Russia, and Sweden) and the United States. The study was conducted from March 2005 to January 2008.


RESULTS
A total of 288 patients were randomly assigned to duloxetine or placebo. Time to a depressive recurrence was significantly longer in duloxetine-treated patients compared with placebo-treated patients (p < .001). During the double-blind maintenance phase, 33.1% of placebo-treated patients experienced a depressive recurrence compared with 14.4% of duloxetine-treated patients (p < .001). There were no significant differences between treatment groups in TEAEs, discontinuations due to adverse events, vital signs, or weight.


CONCLUSIONS
Treatment with duloxetine was associated with a longer time to depressive recurrence and a significantly lower recurrence rate compared with placebo.


BACKGROUND
(ClinicalTrials.gov) Identifier: NCT00105989.
Perahia
David G S
DG
Lilly Research Centre, Erl Wood, Windlesham, Surrey, UK. d.perahia@lilly.com
Maina
Giuseppe
G
Thase
Michael E
ME
Spann
Melissa E
ME
Wang
Fujun
F
Walker
Daniel J
DJ
Detke
Michael J
MJ
D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D055502:Secondary Prevention; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D017678:Sex Distribution; D013876:Thiophenes / Q000627:therapeutic use*
D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes