Prevention of relapse in generalized anxiety disorder by escitalopram treatment.
Escitalopram has demonstrated a robust and dose-dependent efficacy in the treatment of generalized anxiety disorder (GAD) for up to 3 months. In the present study, the efficacy and tolerability of escitalopram in the prevention of relapse in GAD was investigated. A total of 491 patients with a primary diagnosis of GAD and a Hamilton Anxiety (HAMA) total score>or=20 received 12 wk of open-label treatment with a fixed dose of escitalopram (20 mg/d). Of these, 375 patients responded (HAMA total score<or=10) and were randomized to double-blind treatment with 20 mg/d escitalopram (n=187) or placebo (n=188). Treatment was continued for 24-76 wk unless the patient relapsed or was withdrawn for other reasons. Relapse was defined as either an increase in HAMA total score to >or=15, or lack of efficacy, as judged by the investigator. The results of the primary analysis showed a clear beneficial effect of escitalopram relative to placebo on the time to relapse of GAD (log-rank test, p<0.001). The risk of relapse was 4.04 times higher for placebo-treated patients than for escitalopram-treated patients; the proportion of patients who relapsed was statistically significantly higher in the placebo group (56%) than in the escitalopram group (19%) (p<0.001). Escitalopram was well tolerated and 7% of the escitalopram-treated patients withdrew due to adverse events, vs. 8% of the placebo patients. The incidence of discontinuation symptoms with escitalopram during tapered withdrawal was low; the symptoms primarily being dizziness (10-12%), nervousness (2-6%), and insomnia (2-6%). Escitalopram 20 mg/d significantly reduced the risk of relapse and was well tolerated in patients with GAD.
Allgulander
Christer
C
Department of Clinical Neuroscience, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden. christer.allgulander@neurotec.ki.se
Florea
Ioana
I
Huusom
Anna K Trap
AK
D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D001008:Anxiety Disorders / Q000517:prevention & control*; D015283:Citalopram / Q000627:therapeutic use*; D004311:Double-Blind Method; D004361:Drug Tolerance; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D055502:Secondary Prevention; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D018687:Antidepressive Agents, Second-Generation; D015283:Citalopram