FLUVOXAMINE VERSUS CLOMIPRAMINE FOR OBSESSIVE COMPULSIVE DISORDER: A COMPARATIVE STUDY TO DETERMINE SAFETY AND EFFICACY OF THE DRUGS

Abstract

Objective: The aim of this 12-week, blind randomized control comparative study was to determine the safety and efcacy of uvoxamine and clomipramine in adult outpatients with obsessive-compulsive disorder (OCD). Method: 156 adult outpatients with DSM-IV OCD were randomly assigned into two groups to receive 100 to 300 mg of uvoxamine CR (N=78) or Clomipramine (N = 78) once daily at bedtime for 12 weeks. Intentto-treat, analysis of efcacy assessments with the Yale- Brown Obsessive Compulsive Scale (YBOCS), Clinical Global Impressions-Severity of Illness scale (CGI-S) was done. Results: The percentage of responders (response >35% improvement in the YBOCS total score) at the end of the study was similar in both groups (62% FLV vs 65% CMI) by LOCF analysis. Fluvoxamine CR and Clomipramine showed a signicant (>35%) decrease in YBOCS total score beginning at week 2. This early response was sustained at all subsequent visits. At endpoint, there was a mean decrease of 11.65 ± 0.7 (44.89%) in the YBOCS total score compared with baseline in the uvoxamine CR treatment group versus a mean decrease of 12.3 ± 0.7 (46.32%) in the clomipramine treatment group (p = .001). It was observed that FLV was better tolerated than CMI among subjects; patients treated with CMI had more anticholinergic side effects (dry mouth, constipation, and tremor) and premature withdrawals due to adverse events. CGI-S scores also showed a statistically signicant improvement of 59.25% in FLV group and 55.14% in CMI group. Conclusion: The study show that both uvoxamine and clomipramine has equivalent efcacy, wherein both the drugs start showing signicant reduction in primary efcacy parameters: YBOCS and CSI-S scores since the end of second week. Treatment dropout rate was higher in the Clomipramine (24%) group than the uvoxamine (17%) group. We concluded that with long-term or even life- long treatment appearing necessary for people with OCD, Fluvoxamine would appear to be the treatment of choice in view of their tolerability and safety advantages compared with clomipramine.