A Double-Blind Randomized Controlled Trial of Augmentation and Switch Strategies for Refractory Social Anxiety Disorder

作者：Pollack Mark H^*; Van Ameringen Michael; Simon Naomi M; Worthington John W; Hoge Elizabeth A; Keshaviah Aparna; Stein Murray B

来源：American Journal of Psychiatry, 2014, 171(1): 44-53.

DOI：10.1176/appi.ajp.2013.12101353

Objective: Most patients remain symptomatic after an initial intervention with approved treatments for generalized social anxiety disorder. This randomized controlled trial provides systematic, prospectively derived data on the relative benefits of %26quot;next-step%26quot; pharmacotherapies to improve outcomes for individuals with generalized social anxiety disorder who remain symptomatic after initial treatment. %26lt;br%26gt;Method: This three site, 12-week; double-blind randomized controlled trial compared the relative benefits of three strategies for patients remaining symptomatic (Liebowiiz Social Anxiety Scale [LSAS] score %26gt;50) after a 10-week trial of seriraline alone: the addition of up to 3.0 mg/day of clonazepam (sertraline plus clonazepam), a switch to up to 225 mg/day of venlafaxine, or prolonged sertraline treatment with placebo (sertraline plus placebo). %26lt;br%26gt;Results: A total of 397 participants received at least one dose of sertraline; 181 nonresponders (LSAS score %26gt;50) at week 10 were randomly assigned to sertraline plus clonazepam, switch to venlafaxine, or sertraline plus placebo, Overall, 21% of patients achieved remission (LSAS score %26lt;= 30) at the endpoint, and 27% of patients assigned to sertraline plus clonazepam achieved remission compared with patients assigned to sertraline plus placebo (17%) or venlafaxine (19%), but the differences did not reach significance. Sertraline plus clonazepam was associated with a significantly greater drop in LSAS severity (p=0.020) and disability (p=0.0028) compared with sertraline plus placebo; no significant differences were observed on these parameters between venlafaxine and either sertraline plus placebo or sertraline plus clonazepam. In supplemental analysis, the overall response rate (LSAS score %26lt;= 50) was 46%, including a significantly greater proportion of patients in the sertraline plus clonazepam group (56%) compared with the sertraline plus placebo group responding (36%; p=0.027); differences did not reach significance between venlafaxine and sertraline plus placebo or sertraline plus clonazepam. %26lt;br%26gt;Conclusions: The findings suggest that the clonazepam augmentation strategy provides relative benefits for sertraline nonresponders in social anxiety disorder.

• 出版日期2014-1