Conditions: Bipolar I
Keywords: Aripiprazole, Intramuscular (IM) Depot, Bipolar
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 748
Healthy volunteers: no

Brief 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.

Detailed description:
This will be an open-label, uncontrolled study which will enroll subjects completing Study 31-08-250 and new subjects. The treatment history of subjects prior to enrollment in the open-label study will vary according to the design of the pivotal double-blind study (i.e 31-08-250).

This open-label study will be comprised of phases similar to the pivotal double-blind study (i.e. Study 250): a screening phase (if applicable), a conversion phase (Phase A, if applicable), an oral stabilization phase (Phase B, if applicable), and an IM depot open-label maintenance phase (Phase C). Phase C will be a minimum of 28 weeks up to a 52-week treatment period with a 4 week follow up period.

During Phase C (the open-label maintenance phase) rescue medication will be allowed for subjects who do not meet stability criteria. This analysis focuses on Phase C due to ClinicalTrials.gov system limitations.

Arms:
arm 1: Aripiprazole, Intramuscular (IM) Depot

Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: 400mg or 300mg, intramuscular injections every 4 weeks.

Protocol document: