A 1-YEAR DOUBLE-BLIND PLACEBO-CONTROLLED FIXED-DOSE STUDY OF SERTRALINE IN THE TREATMENT OF OBSESSIVE-COMPULSIVE DISORDER

The objective of this study was to evaluate the safety and efficacy, o ver a 1 year treatment period, of three dose levels of sertraline and placebo in the treatment of non-depressed adult out-patients with obse ssive-compulsive disorder (OCD). Following 1 week of single-blind plac ebo washout, patients (n = 325) from 11 sites following identical prot ocols were randomly assigned to 12 weeks of double-blind treatment wit h one of three fixed doses of sertraline (50, 100 or 200 mg) or placeb o. At the end of 12 weeks, treatment responders (including placebo pat ients) were offered an additional 40 weeks of double-blind treatment a t their assigned doses. Efficacy measures were the Yale-Brown Obsessiv e Compulsive Scale, the NIMH Global Obsessive Compulsive Scale, Clinic al Global Impressions of Severity of Illness and Global Improvement an d the Maudsley Obsessive Compulsive Inventory. Patients in the pooled sertraline group showed greater improvement then placebo-treated patie nts on all efficacy measures, based on the endpoint analyses. Moreover , pairwise comparisons at endpoint revealed a significant effect on al l three investigator-rated scales in patients receiving 50 or 200 mg o f sertraline; in the 100 mg group, there was a significant effect on t he NIMH Global Obsessive Compulsive Scale only. Patients completing 3 months of sertraline treatment exhibited excellent toleration and sust ained improvement during an additional 40 weeks of therapy. Results su pport the safety, efficacy and tolerability of daily doses of 50-200 m g of sertraline in the long-term treatment of patients with OCD.