Abstract
BackgroundThe long-acting injectable antipsychotic aripiprazole once-monthly 400 mg (AOM 400) was recently approved for maintenance treatment of bipolar I disorder (BP-I). The purpose of this study was to evaluate the safety, tolerability, and efficacy of AOM 400 as long-term maintenance treatment for BP-I.MethodsThis open-label multicenter study evaluated the effectiveness of AOM 400 as maintenance treatment for BP-I by assessing safety and tolerability (primary objective) and efficacy (secondary objective). The study enrolled AOM 400-naive (“de novo”) patients as well as AOM 400-experienced (“rollover”) patients with BP-I from a lead-in randomized, placebo-controlled clinical trial that demonstrated the efficacy of AOM 400 in the maintenance treatment of BP-I (Calabrese et al. in J Clin Psychiatry 78:324–331, 2017). Safety variables included frequency and severity of treatment-emergent adverse events (TEAEs) and TEAEs resulting in study discontinuation. Efficacy was assessed by the proportion of patients maintaining stability throughout the maintenance phase, as well as mean changes from baseline in Young Mania Rating Scale (YMRS), Montgomery–Asberg Depression Rating Scale, and Clinical Global Impressions for Bipolar Disorder–Severity of Illness Scale (CGI-BP-S) total scores. Patient acceptability and tolerability of treatment was assessed using the Patient Satisfaction with Medication Questionnaire-Modified.ResultsOf 464 patients entering the maintenance phase, 379 (82%) were de novo and 85 (18%) were rollover. TEAEs were more common in de novo than rollover patients. The overall discontinuation rate due to TEAEs was 10.3% (48/464). Improvements in YMRS and CGI-BP-S total scores were maintained during the study, and the vast majority of both de novo (87.0%) and rollover (97.6%) patients maintained stability through their last visit. Overall, the need for rescue medication during the maintenance phase was minimal (< 10% of patients). Patient satisfaction levels were high, with both de novo and rollover patients rating the side effect burden of AOM 400 as greatly improved relative to previous medications.ConclusionAOM 400 was safe, effective, and well tolerated by both de novo and AOM 400-experienced patients with BP-I for long-term maintenance treatment.Trial registration ClinicalTrials.gov, NCT01710709
Highlights
The long-acting injectable antipsychotic aripiprazole once-monthly 400 mg (AOM 400) was recently approved for maintenance treatment of bipolar I disorder (BP-I)
Unlike the patients rolling over from the lead-in study, de novo patients were not stabilized on AOM 400 before the maintenance phase, and use of adjunct rescue medications was permitted
De novo patients were stabilized on oral aripiprazole only, with no stabilization on AOM 400 before the AOM 400 maintenance phase of this study, while all rollover patients were stabilized for 12–28 weeks on AOM 400 according to lead-in study protocol
Summary
The long-acting injectable antipsychotic aripiprazole once-monthly 400 mg (AOM 400) was recently approved for maintenance treatment of bipolar I disorder (BP-I). It has been shown that even during periods of remission, patients with BP-I exhibit high levels of functional and cognitive impairment, leading to a reduced quality of life (Martinez-Aran et al 2004; Martino et al 2009). Combined, these data suggest that treatment during both mood episodes and periods of remission is warranted. Oral therapy has traditionally been used for treatment of BP-I, but newer long-acting injectable (LAI) antipsychotic formulations may allow for better adherence rates, more consistent dosing, more regular contact between patients and their healthcare team, and improved patient outcomes (Brissos et al 2014)
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