Relapse prevention of panic disorder in adult outpatient responders to treatment with venlafaxine extended release.
OBJECTIVE
To compare the long-term efficacy of venlafaxine extended release (ER) with placebo in preventing panic disorder relapse in out-patient treatment responders.


METHODS
Outpatients aged > or = 18 years who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for panic disorder with or without agoraphobia for at least the previous 3 months, with > or = 6 full symptom panic attacks in the 2 weeks prior to screening and > or = 3 in the 2 weeks before baseline and a Clinical Global Impressions-Severity of Illness rating > or = 4 at screen were eligible to participate. Outpatients received flexible-dose (75-225 mg/day) venla-faxine ER for 12 weeks. Treatment responders were randomly assigned to venlafaxine ER or placebo for 26 weeks. Criteria for response were < or = 1 panic attack per week during the last 2 weeks of open-label treatment and a Clinical Global Impressions-Improvement score of 1 or 2. The primary endpoint, time to relapse during double-blind treatment, defined as > or = 2 full symptom panic attacks per week for 2 consecutive weeks or discontinuation due to loss of effectiveness, was evaluated using Kaplan-Meier survival analysis. The study was conducted between December 2001 and August 2003.


RESULTS
The intent-to-treat population had 291 patients in the open-label phase and 169 in the double-blind phase (placebo, N = 80; venlafaxine ER, N = 89; mean daily dose 165-171 mg). Time to relapse was significantly longer with venlafaxine ER than placebo (p < .001). All secondary measures of panic attack treatment efficacy, quality of life, and disability were significantly better with venlafaxine ER than placebo (p < or = .005).


CONCLUSIONS
Venlafaxine ER was safe, well tolerated, and effective in preventing relapse in outpatients with panic disorder.
Ferguson
James M
JM
University of Utah School of Medicine, Psychiatry, Salt Lake City, UT 84103, USA. Drjimferguson@yahoo.com
Khan
Arif
A
Mangano
Richard
R
Entsuah
Richard
R
Tzanis
Evan
E
D000328:Adult; D003511:Cyclohexanols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D006233:Persons with Disabilities / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D016584:Panic Disorder / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D055502:Secondary Prevention; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D000069470:Venlafaxine Hydrochloride
D003511:Cyclohexanols; D003692:Delayed-Action Preparations; D017367:Selective Serotonin Reuptake Inhibitors; D000069470:Venlafaxine Hydrochloride