Duloxetine treatment for relapse prevention in adults with generalized anxiety disorder: a double-blind placebo-controlled trial.
The objective was to examine duloxetine 60-120 mg/day treatment for relapse prevention in adults with generalized anxiety disorder (GAD). Adult patients (N=887; mean age=43.3 years; 61.0% female) with DSM-IV-TR-defined GAD diagnosis were treated with duloxetine for 26 weeks. Patients who completed open-label phase and were treatment responders (>or=50% reduction in Hamilton Anxiety Rating Scale total score to <or=11 and "much"/"very much improved" ratings for the last 2 visits of open-label phase) were randomly assigned to receive duloxetine or placebo for a 26-week double-blind continuation phase. Relapse was defined as >or=2-point increase in illness severity ratings or by discontinuation due to lack of efficacy. During the double-blind phase, placebo-treated patients (N=201) relapsed more frequently (41.8%) than duloxetine-treated patients (13.7%, N=204, P<or=0.001) and worsened on each outcome measure (P<or=0.001, all comparisons). Duloxetine 60-120 mg/day treatment was efficacious and reduced risk of relapse in patients with GAD.
Department of Psychiatry, Duke University Medical School, Durham, NC 27710, USA. jonathan.davidson@duke.edu
Jonathan R T
JR
Davidson
Hans-Ulrich
HU
Wittchen
Pierre-Michel
PM
Llorca
Janelle
J
Erickson
Michael
M
Detke
Susan G
SG
Ball
James M
JM
Russell
D000328:Adult; D000704:Analysis of Variance; D000928:Antidepressive Agents / Q000627:therapeutic use*; D001008:Anxiety Disorders / Q000188:drug therapy* / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D012189:Retrospective Studies; D055502:Secondary Prevention; D013876:Thiophenes / Q000627:therapeutic use*; D013997:Time Factors
D000928:Antidepressive Agents; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride