Oral aripiprazole safely slowed the exacerbation of psychotic symptoms and impending relapse over a 1-year period, according to a study published in the Journal of the American Academy of Child & Adolescent Psychiatry.
In this prospective study, 201 adolescents with schizophrenia (ages 13 to 17) were cross-titrated from their other oral antipsychotic medications for 4 to 6 weeks. Participants were then stabilized on oral aripiprazole (10-30 mg per day) for 7 to 21 weeks before 146 participants were randomly assigned to oral aripiprazole (n=98) or placebo (n=48) for the double-blind maintenance phase of the trial, which lasted for up to 52 weeks.
Participants in the aripiprazole group had a significantly longer time to exacerbation of psychotic symptoms or impending relapse compared with those taking placebo (hazard ratio 0.46; 95% confidence interval, 0.24-0.88; P=.02). Similarly, patients receiving aripiprazole had a significantly longer time to treatment discontinuation compared with patients receiving placebo, excluding discontinuation because of study termination (P=.008).
Aripiprazole treatment trended toward fewer serious treatment-emergent adverse events compared with placebo (3.1% vs 12.5%; P=.06) and was associated with significantly fewer severe treatment-emergent adverse events (2.0% vs 10.4%; P=.04). Compared with placebo, a lower proportion of patients receiving aripiprazole discontinued treatment for treatment-emergent adverse events (20.4% vs 39.6%; P=.01). Extrapyramidal symptoms, weight gain, and somnolence were similar or less common in those taking aripiprazole compared with placebo. Based on Tanner staging, aripiprazole did not appear to have an effect on sexual maturation.
According to the study authors, the results “provide valuable information on longer-term use of oral aripiprazole in adolescents who may benefit early in the course of illness from a medication that combines good efficacy with an acceptable safety and tolerability profile.”
Correll CU, Kohegyi E, Zhao C, et al. Oral aripiprazole as maintenance treatment in adolescent schizophrenia: results from a 52-week, randomized, placebo-controlled withdrawal study. J Am Acad Child Adolesc Psychiatry. 2017;56:784-792.