Abstract:
:Pregabalin is a novel compound in development for the treatment of anxiety disorders. The safety and efficacy of pregabalin for the treatment of social anxiety disorder was evaluated in a double-blind, multicenter clinical trial in which 135 patients were randomized to 10 weeks of double-blind treatment with either pregabalin 150 mg/d. pregabalin 600 mg/d, or placebo. The primary efficacy parameter was change from baseline to end point in the Liebowitz Social Anxiety Scale (LSAS) total score. Safety was assessed through clinical and laboratory monitoring, and recording spontaneously reported adverse events. Ninety-four patients (70%) completed the 11-week double-blind treatment phase. LSAS total score was significantly decreased by pregabalin 600 mg/d treatment compared with placebo (P = 0.024, analysis of covariance). Significant differences (P < or = 0.05) between pregabalin 600 mg/d and placebo were seen on several secondary measures including the LSAS subscales of total fear, total avoidance, social fear, and social avoidance, and the Brief Social Phobia Scale fear subscale. Pregabalin 150 mg/d was not significantly better than placebo on any measures. Somnolence and dizziness were the most frequently occurring adverse events among patients receiving pregabalin 600 mg/d. In conclusion, pregabalin 600 mg/d was an effective and well-tolerated treatment of social anxiety disorder.
journal_name
J Clin Psychopharmacoljournal_title
Journal of clinical psychopharmacologyauthors
Pande AC,Feltner DE,Jefferson JW,Davidson JR,Pollack M,Stein MB,Lydiard RB,Futterer R,Robinson P,Slomkowski M,DuBoff E,Phelps M,Janney CA,Werth JLdoi
10.1097/01.jcp.0000117423.05703.e7subject
Has Abstractpub_date
2004-04-01 00:00:00pages
141-9issue
2eissn
0271-0749issn
1533-712Xjournal_volume
24pub_type
临床试验,杂志文章,多中心研究,随机对照试验abstract::The aim of this study was to compare the disposition of the tricyclic antidepressant clomipramine (C) in Japanese and Swedish patients receiving continuous treatment. Therapeutic drug monitoring data for C and the active metabolite N-desmethylclomipramine (DC) in Japanese patients receiving monotherapy (N = 12) and in...
journal_title:Journal of clinical psychopharmacology
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journal_title:Journal of clinical psychopharmacology
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