Long-acting injectable anti-psychotic aripiprazole once-monthly 400 mg (AOM 400) was effective and well-tolerated in patients with bipolar I disorder for long-term maintenance treatment.
Both AOM 400-naïve (“de novo”) patients and AOM 400-experienced (“rollover”) patients were enrolled in an open-label multicenter study to evaluate the safety and efficacy of AOM 400 as maintenance treatment for bipolar I disorder (ClinicalTrials.gov identifier, NCT01710709). The frequency and severity of treatment-emergent adverse events were analyzed as the primary safety measure. Efficacy was assessed according to the percentage of patients remaining stable during the maintenance phase, as well as score changes from baseline using various bipolar disorder and depression symptom rating scales.
Of 464 total patients in the study, 379 (82%) were de novo and 85 (18%) were rollover. Treatment-emergent adverse events were more commonly recorded in de novo patients (85.2%) compared with rollover patients (60.0%), although the overall discontinuation rate was low (<10%). Scores remained stable during the course of the study on the Young Mania Rating Scale and the Clinical Global Impressions for Bipolar Disorder-Severity of Illness Scale. The majority of both de novo (87.0%) and rollover (97.6%) patients maintained stability throughout the study course. Self-reported satisfaction and tolerability levels were high, with >70% of patients in either group “extremely” or “very” satisfied with AOM 400 treatment. Fewer than 65% of patients reported minimal side effects or fewer side effects than with previous treatment courses. Rescue medication was used in <10% of patients.
These data demonstrate the efficacy and safety of AOM 400 for long-term maintenance treatment of bipolar I disorder and support its broader use in the medical field.
Disclosures: JC has received federal funding from the Department of Defense, Health Resources Services Administration, and National Institute of Mental Health; and grant support from Abbott Laboratories, AstraZeneca, Bristol-Myers Squibb Company, Cephalon, Inc. (now Teva Pharmaceutical Industries Ltd.), Dainippon Sumitomo Pharma Co., Ltd., GlaxoSmithKline, Janssen Pharmaceuticals, Inc., Eli Lilly and Company, Intra-Cellular Therapies, Inc., Pfizer Inc, H. Lundbeck A/S, Sunovion Pharmaceuticals Inc., and Takeda Pharmaceutical Company Limited. He has also served as a consultant/advisory board member/speaker for Abbott Laboratories, Allergan, AstraZeneca, Bristol-Myers Squibb Company, Cephalon, Inc. (now Teva Pharmaceutical Industries Ltd.), Dainippon Sumitomo Pharma Co., Ltd., GlaxoSmithKline, Janssen Pharmaceuticals, Inc., H. Lundbeck A/S, Merck & Co., Inc., Otsuka Pharmaceutical Co., Ltd., Pfizer Inc, Repligen Corporation, Servier, Sunovion Pharmaceuticals Inc., Solvay Pharmaceuticals, Inc., and Takeda Pharmaceutical Company Limited. PS and PH are employees of H. Lundbeck A/S. NJ, BJ, RB, JM, JO, and JA are employees of Otsuka Pharmaceutical Development & Commercialization, Inc. HK has received honoraria for lectures and/or consulting from Dainippon Sumitomo Pharma Co., Ltd., Lundbeck Japan K.K., Mochida Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., and Pfizer Japan Inc.
Calabrese JR, Jin N, Johnson B, et al. Aripiprazole once-monthly as maintenance treatment for bipolar I disorder: a 52-week, multicenter, open-label study [published online June 10, 2018]. Int J Bipolar Disord. doi:10.1186/s40345-018-0122-z