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

New York State Psychiatric Institute, New York, NY 10032, USA.
The Journal of Clinical Psychiatry (Impact Factor: 5.5). 03/2005; 66(2):238-47. DOI: 10.4088/JCP.v66n0213
Source: PubMed


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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    • "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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    ABSTRACT: This article proposes a number of recommendations for the treatment of generalized social phobia, based on a systematic literature review and meta-analysis. An optimal treatment regimen would include a combination of medication and psychotherapy, along with an assertive clinical management program. For medications, selective serotonin reuptake inhibitors and dual serotonin-norepinephrine reuptake inhibitors are first-line choices based on their efficacy and tolerability profiles. The nonselective monoamine oxidase inhibitor, phenelzine, may be more potent than these two drug classes, but because of its food and drug interaction liabilities, its use should be restricted to patients not responding to selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors. There are other medication classes with demonstrated efficacy in social phobia (benzodiazepines, antipsychotics, alpha-2-delta ligands), but due to limited published clinical trial data and the potential for dependence and withdrawal issues with benzodiazepines, it is unclear how best to incorporate these drugs into treatment regimens. There are very few clinical trials on the use of combined medications. Cognitive behavior therapy appears to be more effective than other evidence-based psychological techniques, and its effects appear to be more enduring than those of pharmacotherapy. There is some evidence, albeit limited to certain drug classes, that the combination of medication and cognitive behavior therapy may be more effective than either strategy used alone. Generalized social phobia is a chronic disorder, and many patients will require long-term support and treatment.
    Neuropsychiatric Disease and Treatment 05/2012; 8:203-15. DOI:10.2147/NDT.S23317 · 1.74 Impact Factor
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    • "Five recent reports of randomized controlled trials concerning social anxiety disorder were selected representing five different journals and different authors.[16], [17], [18], [19], [20] A convenience sample of 17 subjects who review manuscripts for publication was selected. All had a doctoral degree but none specialized in the area of social anxiety. "
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    ABSTRACT: To determine the effectiveness of an index in increasing recognition of misleading problem framing in articles and manuscripts. A propaganda index consisting of 32 items was developed drawing on related literature. Seventeen subjects who review manuscripts for possible publication were requested to read five recent published reports of randomized controlled trials concerning social anxiety and to identify indicators of propaganda (defined as encouraging beliefs and actions with the least thought possible). They then re-read the same five articles using a propaganda index to note instances of propaganda. Convenience sample of individuals who review manuscripts for possible publication and sample of recent published reports of randomized controlled trials regarding social anxiety in five different journals by different authors, blinded by author and journal. Data showed that there was a high rate of propagandistic problem framing in reports of RCTs regarding social anxiety such as hiding well argued alternative views and vagueness. This occurred in 117 out of 160 opportunities over five research reports. A convenience sample of 17 academics spotted only 4.5 percent of propaganda indicators. This increased to 64 percent with use of the 32 item propaganda index. Use of a propaganda index increased recognition of related indicators. However many instances remained undetected. This propaganda index warrants further exploration as a complement to reporting guidelines such as CONSORT and PRISMA.
    PLoS ONE 05/2011; 6(5):e19516. DOI:10.1371/journal.pone.0019516 · 3.23 Impact Factor
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    • "2005 ) Sertraline Stahl et al . ( 2003 ) ISRS + ISRN Venlafaxine Adultes Bradwejn et al . ( 2005 ) Phobie sociale ISRS Escitalopram Adultes Lepola et al . ( 2004 ) Paroxétine Montgomery et al . ( 2005 ) Fluoxétine Enfants Birmaher et al . ( 2003 ) Paroxétine Adolescents Clark et al . ( 2005 ) Wagner et al . ( 2004 ) ISRS + ISRN Venlafaxine Adultes Liebowitz et al . ( 2005 ) État de stress ISRS Paroxétine Adultes Marshall et al . ( 2001 ) post - traumatique Sertraline Davidson et al . ( 2001 ) ISRS + ISRN Mirtazapine Adultes Kim et al . ( 2005 ) Trouble ISRS Fluoxétine Enfants Geller et al . ( 2004 ) obsessionnel"

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