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| | | ![]() CINP: High-Dose Sertraline Effective for Obsessive-Compulsive Disorder when Lower Doses Fail By Danny Kucharsky MONTREAL, QC -- June 28, 2002 -- A strategy of high-dose sertraline appears to be of benefit in obsessive-compulsive disorder patients who are not responding to treatment with a standard dose of the drug, according to results of a study conducted in the United States. The findings were presented here on June 27th at the 23rd Congress of the Collegium Internationale Neuro-Psychopharmacologicum (CINP). After 16 weeks of standard-dose sertraline treatment (200 mg/day), patients who did not respond were randomised to continue on sertraline 200 mg/day or to increase their dosage to between 250 mg/day and 400 mg/day for an additional 12 weeks. The researchers found that although both groups improved, the 30 patients in the high-dose group showed significantly greater symptom improvement than the 36 in the 200 mg/day group. The responder rate for the high-dose sertraline was 52 percent on completer analysis compared to 34 percent for the lower dose. However, the difference did not reach statistical significance, the investigators said. Lead investigator Dr. Delbert Robinson, of Hillside Hospital in Glen Oaks, New York, and The Albert Einstein College of Medicine, New York, New York, noted that placebo-controlled trials have established the efficacy of potent serotonin reuptake inhibitors (SRI) but that the proportion of responders to acute treatment is often below 40 percent. He said previous placebo-controlled trials that have examined augmenting SRIs for obsessive-compulsive disorder have failed to find efficacy for desipramine, buspirone, lithium, and clonazepam. An alternative, Dr. Robinson said, is using higher doses of the initial SRI treatment, which can help avoid the drug interactions that can occur when two drugs are co-administered. Because of its relatively well-tolerated safety profile, sertraline seemed suited for testing this strategy in a controlled trial. Among the study’s other findings was that across both treatment groups, 24 patients (36 percent) achieved a clinical response during the 12 weeks of continuation treatment. On the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), the high-dose group showed a significantly faster rate of change across the 12 weeks of continuation treatment, based on random regression analysis (p=0.033). However, the difference in response rates at end point (33 percent for the 200 mg/day group versus 40 percent for the high-dose group) did not reach statistical significance. There were no significant differences in adverse events occurring with greater than 10 percent frequency: Six percent of patients in the 200 mg group and none in the high-dose group discontinued treatment because of adverse events. Dr. Robinson recommended that further study of high-dose SRI treatment and other strategies for treatment-resistant OCD is warranted. The research was supported by Pfizer Inc.
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