Last updated on September 2018

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

Brief description of study

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 Study Description

This will be an open-label, uncontrolled study which will enroll completers from Study 31-08-250 and new subjects not participating in Studies 250. The treatment history of subjects prior to enrolment 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.

Clinical Study Identifier: NCT01710709

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INC Research

Nankoku-shi, Japan

INC Research

Kochi-shi, Japan