DOUBLE-BLIND, RANDOMIZED, CLINICAL TRIAL OF TOPIRAMATE VERSUS SODIUM VALPROATE FOR THE TREATMENT OF BIPOLAR DISORDER IN ADOLESCENTS

Objective: To study the efficacy and safety of Topiramate versus Sodium Valproate for the Treatment of Bipolar Disorder in Adolescents Methodology: One hundred twenty adolescents (aged 12-18) with an admission diagnosis of bipolar I disorder, manic or mixed episode were enrolled from the Adolescent Ward at Ebn-e-Sina Psychiatric Center of Mashhad University. They were assigned to receive 8 weeks of double-blinded, flexibly dosed treatment with topiramate or sodium valproate. The primary efficacy measure was the mean change from baseline to endpoint in the Young Mania Rating Scale (YMRS). Results: Sodium Valproate was superior to topiramate. The YMRS scores decreased significantly in both groups. However, when efficacy of topiramte was analyzed, only 18.64% of the patients showed YMRS scores decrease more than 50% from baseline. Conclusions: This study does not support the efficacy of topiramate as monotherapy in acute mania or mixed episodes in adolescents with bipolar I disorder and sodium valproate was found superior to topiramate.