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Most Effective Med For Social Phobia: Moclobemide

Posted by SalArmy4me on August 28, 2001, at 22:19:27

In reply to Re: Most Effective Med For Social Phobia Rick, posted by Mitch on August 28, 2001, at 7:16:32

Moclobemide for Social Phobia: The Best Med?
The British Journal of Psychiatry
Volume 172(5) May 1998 pp 451-452:

"Sir: The claim made by Schneier et al (1998) [2] that moclobemide is not indicated as a first-line therapy in social phobia should be challenged. Social phobia is a relatively common anxiety disorder, which rarely presents to psychiatrists even when there is marked impairment in occupational and social functioning (Weiller et al, 1996) [3]. Thus, a first-line therapy for social phobia should be effective, well tolerated and suitable for prescription within primary care.

Addressing the latter two issues, moclobemide has a simple dosing regime and is well tolerated; Schneier et al found eight-week drop-out rates were 24% on moclobemide v. 25% on placebo. Their most serious objection to the use of moclobemide as a first-line treatment is one of efficacy. They found 23% of patients with severe or very severe social phobia treated with moclobemide for eight weeks were rated as much or very much improved (v. 0% in the placebo group), although numbers were too small to reach statistical significance. This finding of greater efficacy in more severe social phobia is also supported by the International Multicenter Clinical Trial Group on Moclobemide in Social Phobia (1997) [1] who found patients with severe social phobia treated with 600 mg moclobemide had a 52% response rate (v. 32% on placebo)."

Dimensional Versus Categorical Response to Moclobemide in Social Phobia: Reply to Letter
University of Iowa College of Medicine; Psychiatry Research; Iowa City, Iowa 52242-1000:

"Drs. Blanco and Liebowitz feel that we may have demonstrated efficacy for moclobemide in our social phobia trial that we failed to appreciate. [1] Their letter gives us an opportunity to clarify several points.

First, not all controlled trials have shown efficacy. [1-4] For instance, Schneier and associates [2] observed few differences between moclobemide (mean dose of 728 mg daily) and placebo after 8 weeks, and the International Multicenter Trial [3] indicated modest superiority for 600 mg daily (47% at least moderately improved on moclobemide vs. 34% on placebo) but not for 300 mg.

It is not clear whether the difference between drug (moclobemide 900 mg) and placebo that we observed on the Liebowitz Social Anxiety Scale at 12 weeks (mean +/- SE, 55.7 +/- 3.5 vs. 51.6 +/- 3.5) is clinically, although statistically, significant. When evaluating results it is important to consider all measures, and in this case, few statistically significant differences were observed at the end of 12 weeks for any of the fixed doses ranging from 75 to 900 mg daily.

In our trial the clinical impression of change was used to determine responder status (rating scale of 1 [very much improved] to 7 [very much worse]). As Drs. Blanco and Liebowitz indicate, categorical measures of this kind are often less sensitive to drug-placebo differences. This is not always the case, however, and this measure was selected as the primary measure of efficacy before starting the trial. Such global ratings of change are important because they reflect meaningful change; without them it can be difficult to gain a clinical sense of the outcome of a trial.

Drs. Blanco and Liebowitz noted that in our trial, subjects receiving moclobemide 900 mg daily continued to improve between 8 and 12 weeks, and they attributed this improvement to the drug. Unfortunately, data concerning change in effect size between 8 and 12 weeks were not available, so we could not support their inference.

Had our trial ended at 8 weeks, we might have concluded that the highest fixed dose of moclobemide (900 mg daily) is effective. However, most of the differences seen at 8 weeks disappeared at 12 weeks for unknown reasons. Differences at 8 weeks may have been chance findings; tolerance to early drug effects may have developed by 12 weeks, or robust response to placebo may have overwhelmed the small drug effects seen earlier.

It is certainly possible, as we stated in our report, that moclobemide is effective for social phobia but at doses higher than those used. Nevertheless, the safety of such doses has not, to our knowledge, been established. Given the proven efficacy of standard monoamine oxidase inhibitors (MAOIs) (i.e., phenelzine), [4] reversible MAOIs remain an attractive alternative. Further efforts to establish efficacy or lack of it are warranted."

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