MOCLOBEMIDE IN SOCIAL PHOBIA - A DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL-STUDY

The primary objectives of this large multicenter study (n=578) were to determine the efficacy and safety of moclobemide, 300 or 600 mg per d ay, for the treatment of social phobia. A double-blind fixed-dose para llel group study was conducted to compare the two different doses of m oclobemide to placebo. After a 1-week placebo run-in period, patients were randomly assigned to one of the three treatment groups to receive the test compound for a 12-week period. Assessments were performed at screen, on baseline and on weeks 1, 2, 3, 4, 6, 8, 10, and 12. There were consistent, reliable and clinically meaningful drug effects and i ndications of a dose-response relationship. Statistical analysis of th e results at both weeks 8 and 12 showed that 600 mg of moclobemide was effective and statistically significantly superior to placebo. The 30 0 mg dose also showed better efficacy than placebo on all measures of efficacy, and about half of them were statistically significantly diff erent from placebo. Moclobemide was well tolerated. Adverse events, ex cept for insomnia, were neither dose-related nor were there significan t drug-placebo differences. The results indicate that 600 mg of moclob emide per day given b.i.d. is effective in social phobia, reducing the symptoms and the impairment associated with the disorder. The compoun d is well tolerated and safe.