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

ABSTRACT:

Objective

This study aimed to characterize long-term safety and tolerability of brexpiprazole, an atypical antipsychotic, as maintenance treatment in adolescents with schizophrenia.

Method

This was an interim analysis of an ongoing, 24-month, multicenter, single-arm, open-label, outpatient study of oral brexpiprazole 1 to 4 mg/day (flexible dose) in adolescents aged 13 to 17 years with schizophrenia. Primary end points were incidence of treatment-emergent adverse events (TEAEs), TEAEs by severity, serious TEAEs, and adverse events leading to study discontinuation.

Results

At the time of 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 withdr

SUBMITTER: Atkinson SD 

PROVIDER: S-EPMC12166907 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature