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A Double-blind, Placebo-Controlled Study of Risperidone Addition in Serotonin Reuptake Inhibitor–Refractory Obsessive-compulsive Disorder
Christopher J. McDougle, MD;
C. Neill Epperson, MD;
Gregory H. Pelton, MD;
Suzanne Wasylink, RNC;
Lawrence H. Price, MD
Arch Gen Psychiatry. 2000;57:794-801.
Background To date, only 1 controlled study has found a drug (haloperidol) to be efficacious in augmenting response in patients with obsessive-compulsive disorder (OCD) refractory to serotonin reuptake inhibitor (SRI) monotherapy; patients with comorbid chronic tic disorders showed a preferential response. This report describes the first controlled study of risperidone addition in patients with OCD refractory to treatment with SRI alone.
Methods Seventy adult patients with a primary DSM-IV diagnosis of OCD received 12 weeks of treatment with an SRI. Thirty-six patients were refractory to the SRI and were randomized in a double-blind manner to 6 weeks of risperidone (n = 20) or placebo (n = 16) addition. Behavioral ratings, including the Yale-Brown Obsessive Compulsive Scale, were obtained at baseline and throughout the trial. Placebo-treated patients subsequently received an identical open-label trial of risperidone addition.
Results For study completers, 9 (50%) of 18 risperidone-treated patients were responders (mean daily dose, 2.2 ±0.7 mg/d) compared with 0 of 15 in the placebo addition group (P<.005). Seven (50%) of 14 patients who received open-label risperidone addition responded. Risperidone addition was superior to placebo in reducing OCD (P<.001), depressive (P<.001), and anxiety (P = .003) symptoms. There was no difference in response between OCD patients with and without comorbid diagnoses of chronic tic disorder or schizotypal personalty disorder. Other than mild, transient sedation, risperidone was well tolerated.
Conclusion These results suggest that OCD patients with and without comorbid chronic tic disorders or schizotypal personality disorder may respond to the addition of low-dose risperidone to ongoing SRI therapy.
From the Department of Psychiatry, Section of Child and Adolescent Psychiatry, Indiana University School of Medicine, Indianapolis (Dr McDougle); Department of Psychiatry, Yale University School of Medicine, New Haven, Conn (Dr Epperson and Ms Wasylink); Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY (Dr Pelton); and the Department of Psychiatry and Human Behavior, Brown University School of Medicine, Providence, RI (Dr Price). Dr McDougle has been a paid consultant and a member of the speakers' bureau for Eli Lilly and Co, Indianapolis, Ind, and a member of the speakers' bureau for Pfizer Inc, New York, NY; Janssen Pharmaceutica, Titusville, NJ; and Solvay Pharmaceuticals, Marietta, Ga.
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