A 2-YEAR STUDY OF SERTRALINE IN THE TREATMENT OF OBSESSIVE-COMPULSIVEDISORDER

The present study investigated the tolerability, safety profile, and a nti-obsessional efficacy of sertraline, a selective serotonin reuptake inhibitor, during long-term treatment of patients with obsessive-comp ulsive disorder (OCD). Fifty-nine OCD patients who had completed a 1 y ear double-blind, fixed dose study comparing sertraline and placebo su bsequently entered a 1-year open extension. Among the 51 patients who had been treated with sertraline during the double-blind phase, the me an total duration of sertraline treatment was 690 days. Only treatment responders who completed the 52-week double-blind treatment phase wer e permitted to enter the open extension. The higher rate (p < 0.02) of sertraline patients (51 out of 241) than of placebo patients (eight o ut of 84), who responded to treatment and entered the open-label phase is therefore consistent with the greater mean improvement observed in the sertraline group during double-blind treatment. Placebo responder s differed from sertraline responders in that they were less impaired at baseline of the double-blind study [Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) of 18.5 versus 23.4] and they exhibited less improveme nt during double-blind treatment (-6.1 versus -11.4). In the open-labe l phase all patients received sertraline at a starting dose of 50 mg o nce a day, titrated in 50 mg increments to a maximum dose of 200 mg ac cording to clinical response. At end-point the mean Y-BOCS score for a ll patients decreased by a further 3.6 points. Patients previously tre ated with placebo showed greater improvement after being switched to s ertraline than those who received continued sertraline treatment. Pati ents who completed the study and received 2 full years of sertraline t reatment (n = 38) exhibited a mean improvement of 15.6 points using th e Y-BOCS. Sertraline was well tolerated during both the double-blind p hase and the open extension, and the incidence of adverse experiences was generally reduced during the second year of treatment. Three patie nts discontinued open treatment because of adverse experiences. Long-t erm sertraline treatment did not appear to be associated with the emer gence, increased incidence, or increased severity of adverse experienc es or clinically significant abnormalities in laboratory tests, vital signs, or the electrocardiogram. The study supports the long-term safe ty and tolerability of sertraline over a 2-year treatment course and t he sustained efficacy of sertraline in patients with OCD.