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A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Desvenlafaxine Extended-Release Tablets in Generalized Social Anxiety Disorder

Michael R. Liebowitz, Ester Salmán, Ann Johnso and Rita Hanover

Abstract Objective: The purpose of the study was to asses the efficacy of desvenlafaxine in patients with the generalized form of Social Anxiety Disorder (GSAD). Methods: 63 patients with GSAD were randomized to desvenlafaxine or placebo in a 12 week double blind trial. Change from baseline to endpoint on the Liebowitz Social Anxiety Scale (LSAS) was the primary outcome measure. Secondary outcome measures included response, defined as much improved or very much improved on the Clinical Global Impression of Change (CGI-I) and remission rates (defined as the proportion of patients with an endpoint LSAS total score of 30 or less. Changes in depression and anxiety, measured by the Hamilton Depression (Ham-D 17) and Anxiety Scales (Ham-A), were also assessed. Outcome analyses were performed in the intent to treat (ITT) and completer samples. Results: The mean baseline LSAS was 92.8 and mean Clinical Global Impression of Severity (CGI-S) was 5.4, indicating severe illness, with no baseline differences between treatment groups. At the end of treatment, in the ITT sample (N=58), the drug group had improved more than the placebo group by 9.7 points on the LSAS, a trend difference (p=0.085, 1 tailed). Cohen’s d was 0.36, indicative of a moderate effect size. There were also trend differences in response (69% versus 48.3%, p=0.09, 1 tailed) and remission rates (20.7% versus 3.4%, p=0.051, t tailed), and significant differences on the Hamilton Depression scale (2.5 versus 0.3, p=0.02, 1 tailed) in favor of desvenlafaxine. Findings in the completer sample were similar to those in the ITT sample. Conclusions: These findings must be considered preliminary because the limited sample size reduced statistical power and renders interpretation of the findings less precise.. Nevertheless these initial results suggest that desvenlafaxine has efficacy for social anxiety disorder similar to that seen with more extensively studied medications that have received FDA approval for this condition. Therefore, pending further study, desvenlafaxine may prove to be a useful treatment for Social Anxiety Disorder.