Social Anxiety Disorder

The ECNP consensus meeting on SAD72 recommended the conventional double-blind, placebo-controlled, randomized group comparison study to demonstrate efficacy in SAD. Since the latter can be either generalized or nongeneralized, studies investigating efficacy in this disease concentrate on generalized SAD with symptoms of at least four distinct social situations. As in other anxiety disorders, there is a larger drug versus placebo effect seen in patients in the severe to moderate SAD subgroups, as based on scores of 50-70 in the Liebowitz social anxiety scale (LSAS). A potential confounding issue in SAD trials is the presence or absence of comorbid disease. For example, patients suffering from major depressive disorder over the previous 3-6 months should be excluded from the SAD trial if the study will include a potential antidepressant so the results can be deemed relevant for the general population with SAD rather than those with comorbid MDD. The LSAS is the current gold standard scale used to establish efficacy in SAD trials.73 The brief social phobia scale (BSPS) has also been widely used to establish efficacy.74 The clinical global scales (clinical global impression (CGI) improvement and CGI severity) have been used in SAD trials, but these global scales are not recommended as primary scales and are used as secondary scales to help judge the clinical relevance of the trial finding. Trials of 8-12 weeks duration are used to establish efficacy in SAD.72'73

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