Metabolic effects of adding Topiramate on Aripiprazole in bipolar patients aged between 6-18 years, a randomized, double-blind, placebo-controlled trial

BACKGROUND: second-generation antipsychotics (SGAs) are associated with metabolic side effects in child and adolescents. The aim of this study is to evaluate the metabolic effects of adding topiramate on aripiprazole in patients with bipolar disorder (BD) aged between 6 and 18 years. MATERIALS AND METHODS: A 12-week, double-blind, placebo-controlled, randomized trial was conducted in the child psychiatric units of university hospitals. Forty patients aged between 6 and 18 years with new diagnosis of BD participated in the study. Eleven patients were excluded. Subjects received aripiprazole plus topiramate (Group 1, n = 15) or aripiprazole (Group 2, n = 14) for a 3-month period. Young mania rating scale (YMRS) was used for measuring the manic symptoms severity. Primary outcome measures included weight, height, body mass index (BMI), waist circumference, abdominal circumference, and blood pressure. Secondary outcome measures included fasting blood glucose, hemoglobin A1C, fasting insulin, and fasting lipid profile. Changes in metabolic profile during the study were obtained by using repeated measures of variance. RESULTS: During a 3-month follow-up, YMRS measures decreased significantly in both groups with a significant difference between groups (P < 0.05). The mean of weight, BMI, and high-density lipoprotein levels in group 2 were significantly increased (P < 0.05), and the mean of low-density lipoprotein level in group 1 was decreased (P < 0.05). No significant differences were observed in anthropometric parameters and metabolic indices between groups (P > 0.05). CONCLUSION: Adding topiramate on aripiprazole is effectivefor controlling bipolar disorder as well as metabolic adverse effects of SGAs in juvenile patients.