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Awarded Trial: 01-RC-310-4
Secondary Drug Intervention
Duration of Study Period for Each Subject
An investigator selected sample of 26 patients with various bipolar disorders who had a history of poor response to mood stabilizers were followed for one year on a combination of olanzapine and topirimate. A statistically significant reduction in manic and depressive symptoms as measured by the YMRS and HAM-D was seen. Using an intent to treat analysis with at least a 50%reduction in symptoms defined as improvement, 13 of 26 patients were considered responders. The overalll relapse rate for the study was significantly lower than the relapse rate during the previous year. At the 12 month endpoint the mean weight change was -.5 (+/- 1.1) kg. The most frequently reported side effect was somnolence (23.1%).
Vieta E, et al. Effects on weight and outcome of long-term olanzapine-topiramate combination treatment in bipolar disorder. J Clin Psychopharmacol. 2004;24:374-378.
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