Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder

Summary

This will be an open-label uncontrolled trial to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar I disorder. The trial will enroll subjects who completed Trial 31-08-250 and de novo subjects not participating in Trial 31-08-250.

Timeline

Start

2012-11

Primary completion

2016-11

Completion

2016-12

Publications

• Bell Lynum KS, Such P, Zhang Z, Simmons-Yon A, Atkins N, Lawson W, Goldberg JF. Safety and Efficacy of Maintenance Treatment With Aripiprazole Once-Monthly in Black/African American Adults Diagnosed With Bipolar I Disorder: Post Hoc Analysis of a 52-Week, Open-Label Study. J Clin Psychiatry. 2026 Mar 9;87(2):25m16114. doi: 10.4088/JCP.25m16114.
• Calabrese JR, Jin N, Johnson B, Such P, Baker RA, Madera J, Hertel P, Ottinger J, Amatniek J, Kawasaki H. Aripiprazole once-monthly as maintenance treatment for bipolar I disorder: a 52-week, multicenter, open-label study. Int J Bipolar Disord. 2018 Jun 10;6(1):14. doi: 10.1186/s40345-018-0122-z.

Drugs

Indications