The safety and tolerability of aripiprazole once-monthly as maintenance treatment for bipolar I disorder: A double-blind, placebo-controlled, randomized withdrawal study

Journal of Affective Disorders
Joseph R CalabreseW H Carson

Abstract

Aripiprazole once-monthly 400 mg (AOM 400), an atypical long-acting injectable antipsychotic, has demonstrated efficacy and safety in maintenance treatment of bipolar I disorder (BP-I). We further assess safety and tolerability and characterize adverse events (AEs) across the duration of aripiprazole exposure. Patients with BP-I were stabilized on oral aripiprazole (2-8 weeks), AOM 400 (12-28 weeks), followed by 1:1 randomization of patients meeting stability criteria to a 52-week, double-blind, placebo-controlled withdrawal phase. Treatment-emergent AEs (TEAEs) were collected across study phases. AEs were counted in a phase if they were drug-related and continued from the baseline of that phase. A separate analysis on new-onset akathisia was conducted. Among TEAEs occurring in ≥10% of patients during all study phases were akathisia (23.3%) and weight increased (10.6%). Median time to akathisia onset was 20 days after starting oral aripiprazole; median duration was 29 days for the first occurrence; 21/168 patients (12.5%) reporting akathisia experienced >1 episode. Episodes of new-onset akathisia decreased over time, with few events reported in the randomized phase. Weight gain was minimal with oral aripiprazole, generally star...Continue Reading

Citations

Feb 13, 2019·Expert Review of Neurotherapeutics·Renee-Marie Ragguett, Roger S McIntyre
Aug 31, 2019·Drugs·Jean-Michel Azorin, Nicolas Simon
Feb 23, 2021·Expert Opinion on Pharmacotherapy·Ahmad Sleem, Rif S El-Mallakh
Apr 14, 2021·Expert Opinion on Pharmacotherapy·Georgios D KotzalidisSergio De Filippis

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