Article

A Randomized Controlled Trial of Venlafaxine Extended Release in Generalized Social Anxiety Disorder

University of Ottawa, Ottawa, Ontario, Canada
The Journal of Clinical Psychiatry (Impact Factor: 5.5). 03/2005; 66(2):238-47. DOI: 10.4088/JCP.v66n0213
Source: PubMed

ABSTRACT

Generalized social anxiety disorder is a debilitating psychiatric illness characterized by maladaptive thoughts about social situations. This double-blind study evaluated the anxiolytic efficacy, safety, and tolerability of venlafaxine extended release (ER) in adult out-patients with generalized social anxiety disorder.
Patients were randomly assigned to receive 12 weeks of treatment with a flexible dose of venlafaxine ER (75 to 225 mg/day) or placebo. The Liebowitz Social Anxiety Scale (LSAS) total score was the primary efficacy variable. Secondary efficacy variables included scores on the Clinical Global Impressions-Severity of Illness (CGI-S) and -Improvement (CGI-I) scales, Social Phobia Inventory (SPIN), and LSAS subscales. Response was defined as a CGI-I score of 1 or 2. Two definitions of remission were used: LSAS total score < or = 30 and CGI-I score of 1.
Data from 271 patients (intent-to-treat population) were analyzed for efficacy; 279 patients were analyzed for safety. Overall, 173 patients completed the study. Improvement on the LSAS was significantly greater with venlafaxine ER treatment than with placebo at weeks 6 through 12 (p < .05, weeks 6 and 8; p < .01, week 10; and p < .001, week 12) and at weeks 8 through 12 based on CGI-S and SPIN scores. Week 12 response and remission (LSAS score < or = 30) rates were significantly greater in the venlafaxine ER group than in the placebo group (response: 44% vs. 30%, respectively, p = .018; remission: 20% vs. 7%, respectively, p < .01). Patients experienced no unexpected or serious adverse events.
Venlafaxine ER is safe, well tolerated, and efficacious in the short-term treatment of generalized social anxiety disorder.

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    • "The primary outcomes response and remission were based on the Liebowitz-Social-Anxiety-Scale (LSAS)[10]. Following recommendations by[26], remission was defined by a Liebowitz-Social-Anxiety-Scale score 30[24,26]. Response was defined by a 31% reduction (or more) in the Liebowitz-Social-Anxiety-Scale which iscomparable to Clinical Global Impression Improvement scale score 2 usually used to define response[27]. Endstate functioning of social anxiety was defined as the post treatment LSAS score. "
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    • "Venlafaxine is the only serotonin-norepinephrine reuptake inhibitor (SNRI) studied in RCT in patients with social phobia, but improvements in social phobia symptom ratings have also been shown in an open-label trial of the SNRI, duloxetine.45 All five reported studies23,28,46–48 have shown significantly greater response rates for venlafaxine compared with placebo (Figure 2, OR range for treatment response 1.89–3.78). Four of five studies used flexible dosing, with mean daily doses of approximately 200 mg/day. "
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