High-Dose Sertraline Strategy for Nonresponders to Acute Treatment for Obsessive-Compulsive Disorder: A Multicenter Double-Blind Trial.

Author(s): Ninan PT, Koran LM, Kiev A, Davidson JR, Rasmussen SA, Zajecka JM, Robinson DG, Crits-Christoph P, Mandel FS, Austin C

Affiliation(s): From the Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Ga. (Dr. Ninan); the Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, Calif. (Dr. Koran); the Social Psychiatry Research Institute, New York, N.Y. (Dr. Kiev); the Department of Psychiatry, Duke University, Durham, N.C. (Dr. Davidson); the Department of Psychiatry and Human Behavior, Brown University, Providence, R.I. (Dr. Rasmussen); the Department of Psychiatry, Rush-Presbyterian-St. Luke's Medical Center, Chicago, Ill. (Dr. Zajecka); Hillside Hospital, Glen Oaks, and Albert Einstein College of Medicine, Bronx, N.Y. (Dr. Robinson); the Department of Psychiatry, University of Pennsylvania, Philadelphia (Dr. Crits-Christoph); and Pfizer Inc, New York, N.Y. (Drs. Mandel and Austin).

Publication date & source: 2006-01, J Clin Psychiatry., 67(1):15-22.

Publication type:

OBJECTIVE: To evaluate the efficacy and safety of high-dose sertraline for patients with obsessive-compulsive disorder (OCD) who failed to respond to standard sertraline acute treatment. METHOD: Sixty-six nonresponders to 16 weeks of sertraline treatment who met DSM-III-R criteria for current OCD were randomly assigned, in a double-blind continuation phase of a multicenter trial, either to continue on 200 mg/day of sertraline or to increase their dose to between 250 and 400 mg/day for 12 additional weeks. Efficacy measures included the Yale-Brown Obsessive Compulsive Scale (YBOCS), the National Institute of Mental Health Global Obsessive Compulsive Scale (NIMH Global OC Scale), and the Clinical Global Impressions-Severity of Illness and -Improvement (CGI-I) scales. Data were collected from July 26, 1994, to October 26, 1995. RESULTS: The high-dose (250-400 mg/day, mean final dose = 357, SD = 60, N = 30) group showed significantly greater symptom improvement than the 200-mg/day group (N = 36) as measured by the YBOCS (p = .033), NIMH Global OC Scale (p = .003), and CGI-I (p = .011). Responder rates (decrease in YBOCS score of >/= 25% and a CGI-I rating </= 3) were not significantly different for the 200-mg/day versus the high-dose sertraline group, either on completer analysis, 34% versus 52%, or on endpoint analysis, 33% versus 40%. Both treatments showed similar adverse event rates. CONCLUSION: Greater symptom improvement was seen in the high-dose sertraline group compared to the 200-mg/day dose group during continuation treatment. Both dosages yielded similar safety profiles. Administration of higher than labeled doses of selective serotonin reuptake inhibitors may be a treatment option for certain OCD patients who fail to respond to standard acute treatment.