TREATMENT OF OBSESSIVE-COMPULSIVE DISORDER WITH FLUVOXAMINE - A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

One hundred and sixty patients with a primary diagnosis of obsessive-c ompulsive disorder were enrolled in a multicentre, randomized, double- blind, placebo-controlled study of fluvoxamine. After a placebo washou t phase, patients were randomized to treatment with placebo or fluvoxa mine (100-300 mg/day) for 10 weeks. Seventy-eight patients in each gro up were evaluable for efficacy. Fluvoxamine was significantly more eff ective than placebo as assessed by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), the National Institute of Mental Health Obsessive-Com pulsive (NIMH-OC) scale and the Global Improvement item of the Clinica l Global Impression (CGI) scale. The percentage of patients classified as ''responders'' (much or very much improved according to the Global Improvement item) was also significantly higher in the fluvoxamine gr oup from Week 6 onwards, with 33.3% of fluvoxamine-treated patients an d 9.0% of those given placebo classified as ''responders'' at endpoint . The ''responders' to fluvoxamine experienced a substantial clinical benefit as reflected in decreases in their Y-BOCS and NIMH-OC scores. Fluvoxamine was well tolerated with the majority of adverse events con sidered mild or moderate.