Double-blind, randomized, clinical trial of topiramate versus sodium valproate for the treatment of bipolar disorder in adolescents

ABSTRACT

To study the efficacy and safety of Topiramate versus Sodium Valproate for the Treatment of Bipolar Disorder in Adolescents. 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]. 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. 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