Cardiometabolic Adverse Effects and Its Predictors in Children and Adolescents With First-Episode Psychosis During Treatment With Quetiapine-Extended Release Versus Aripiprazole: 12-Week Results From the Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis (TEA) Trial.

OBJECTIVE: To investigate cardiometabolic effects and their predictors in youths with first-episode psychosis (FEP) treated with quetiapine-extended release (ER) versus aripiprazole. METHOD: Youths with FEP who were 12 to 17 years of age were randomized to quetiapine-ER or aripiprazole in the 12-week, double-blinded, Tolerability and Efficacy of Antipsychotics (TEA) trial. Primary outcome was change in body weight; secondary outcomes were changes in body mass index (BMI) and waist circumference (WC), blood pressure (BP), heart rate, and lipid and glucose metabolism parameters. Possible predictors of cardiometabolic changes were examined. RESULTS: Altogether, 113 patients (schizophrenia-spectrum disorders = 93%; age [mean ± SD] = 15.7 ± 1.4 years; male participants = 30.1%) were randomized to quetiapine-ER (n = 55) or aripiprazole (n = 58). Quetiapine-ER led to significant increases in body weight (4.88 kg, 95% CI = 3.92-5.83, p \u3c .0001), BMI z-score (0.43, 95% CI = 0.33-0.53, p \u3c .0001), and WC z-score (0.97, CI = 0.7-1.23, p \u3c .0001). Changes were significantly smaller with aripiprazole (all between-group p values CONCLUSION: In youths with FEP, quetiapine-ER was associated with significantly greater weight gain and adverse changes in metabolic outcomes than was aripiprazole. Early weight gain must be addressed and family lifestyle factors taken into consideration when treating youths with antipsychotics. CLINICAL TRIAL REGISTRATION INFORMATION: Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis (TEA); https://clinicaltrials.gov; NCT01119014