In a randomized, double-blind, placebo-controlled, clinical trial in a multicenter study, researchers from The Department of Psychiatry and Behavioral Sciences at Duke University Medical Center compared the effects of fluoxetine (Prozac), with cognitive behavioral therapy in alleviating generalized social phobia.

This study compared fluoxetine (FLU), comprehensive cognitive behavioral group therapy (CCBT), placebo (PBO), and the combinations of CCBT/FLU and CCBT/PBO. Seven hundred twenty-two people with social phobia were screened, and 295 were randomized for the 14-week treatments in each condition. Fluoxetine and PBO were administered at doses from 10 mg/d to 60 mg/d (or equivalent), and group comprehensive cognitive behavioral therapy was administered weekly for 14 sessions. An independent blinded evaluator assessed response with the Brief Social Phobia Scale and Clinical Global Impressions scales as primary outcomes. A videotaped behavioral assessment served as a secondary outcome, using the Subjective Units of Distress (SUDS) Scale. Adverse effects were measured by self-rating. The study found all treatment conditions were significantly better than the placebo. Prozac (FLU) was more effective than CCBT/FLU, CCBT/PBO, and PBO at week 4; CCBT was also more effective than CCBT/FLU and CCBT/PBO. By the final visit, all active treatments were superior to PBO but did not differ from each other.

The study concluded that all active treatments were superior to placebo on primary outcomes. Combined treatment did not yield any further advantage. Despite the benefits of treatment, many patients remained symptomatic after 14 weeks.

Citation: Davidson JR, Foa EB, Huppert JD, Keefe FJ, Franklin ME, Compton JS, Zhao N, Connor KM, Lynch TR, Gadde KM.Fluoxetine, comprehensive cognitive behavioral therapy, and placebo in generalized social phobia. Archives of General Psychiatry. 2004 Oct; 61 (10): pages 1005-13. [email protected]