Safety and Tolerability of Brexpiprazole in Adolescents With Schizophrenia: A Long-Term, Open-Label Study

ObjectiveTo characterize the long-term safety and tolerability of brexpiprazole, an atypical antipsychotic, as maintenance treatment in adolescents with schizophrenia.MethodThis was an interim analysis of an ongoing, 24-month, multicenter, single-arm, open-label, outpatient study of oral brexpiprazole 1–4 mg/day (flexible dose) in patients aged 13–17 years with schizophrenia. Primary endpoints were the incidence of treatment-emergent adverse events (TEAEs), TEAEs by severity, serious TEAEs, and adverse events (AEs) leading to study discontinuation.ResultsAt the time of the interim analysis, 169 patients had entered the study, 114 (67.5%) were ongoing, 23 (13.6%) had completed the full 24 months, and 32 (18.9%) had discontinued – most commonly due to withdrawal by the patient. The study sample was 52.7% female patients and 79.9% White patients, with a mean age of 15.6 years. Overall, 95/167 treated patients (56.9%) reported ≥1 TEAE, most commonly somnolence (10.2%), headache (9.0%), weight increase (9.0%), and nasopharyngitis (6.6%). Most TEAEs were mild or moderate in severity. Thirty-three patients (19.8%) had clinically meaningful weight gain after adjusting for natural growth. Five patients (3.0%) reported a serious TEAE (two psychotic disorder; one each of non-fatal suicide attempt, pilonidal cyst, and psychomotor hyperactivity), all of which resolved during the study. Two patients (1.2%) discontinued the study due to AEs: one following the serious non-fatal suicide attempt, and the other due to hyperpituitarism and weight increase, which were considered stable at the time of discharge.ConclusionBrexpiprazole, when used as maintenance treatment for adolescents with schizophrenia, has a safety profile generally consistent with that observed in adult patients. Any weight gain in adolescent patients should be carefully monitored and compared against that associated with normal growth.