Citation

Calabrese JR, Jin N, Johnson B, Such P, Baker RA, Madera J, Hertel P, Ottinger J, Amatniek J, Kawasaki H. Int. J. Bipolar Disord. 2018; 6(1).

Copyright

(Copyright © 2018, Holtzbrinck Springer Nature Publishing Group)

DOI

10.1186/s40345-018-0122-z

PMID

unavailable

Abstract

BACKGROUND: The 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.

METHODS: This 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.

RESULTS: Of 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.

CONCLUSION: AOM 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. © 2018, The Author(s).

Language: en

Keywords

Safety; adult; human; female; male; aged; insomnia; suicidal ideation; depression; randomized controlled trial; lithium; obesity; comparative study; major clinical study; controlled study; questionnaire; neuroleptic agent; automutilation; priority journal; headache; somnolence; anxiety disorder; drug safety; placebo; benzodiazepine derivative; drug efficacy; tardive dyskinesia; diarrhea; drug tolerability; tremor; multicenter study; akathisia; lorazepam; restlessness; patient satisfaction; valproic acid; mania; bipolar I disorder; maintenance therapy; pharyngitis; dyspnea; Bipolar I disorder; Maintenance treatment; aripiprazole; drug dose reduction; Montgomery Asberg Depression Rating Scale; Article; injection site reaction; Patient satisfaction; upper respiratory tract infection; Young Mania Rating Scale; Columbia Suicide Severity Rating Scale; Aripiprazole once-monthly; Clinical Global Impressions for Bipolar Disorder Severity of Illness Scale; Medication Questionnaire-Modified