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

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.

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.

Eligibility Criteria:
Inclusion Criteria:

* Completed participation in Trial 31-08-250
* De novo subjects not participating in Trial 31-08-250
* Subjects who are able to provide written informed consent.
* Male and female subjects 18 years of age or older at time of informed consent
* Subjects who, in the investigator's judgment, require chronic treatment with an antipsychotic medication for their bipolar I disorder and would benefit from extended treatment with a long-acting injectable formulation
* Subjects who have a recurrence of mood episode or exacerbations of mood symptoms when they are not receiving treatment for their bipolar I disorder or are noncompliant with treatment for their bipolar I disorder
* Have an outpatient status

Exclusion Criteria:

* Experienced 9 or more mood episodes within the past year
* A current manic episode with a duration of \> 2 years
* Currently meet DSM-IV-TR criteria for substance abuse or substance dependence; this includes the abuse of alcohol and benzodiazepines, but excludes the use of caffeine and/or nicotine
* Hypothyroidism or hyperthyroidism, unless condition has been stabilized
* Diagnosed with epilepsy or a history of seizures
* Known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones
* Sexually active women of childbearing potential and sexually active men who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during this trial and for 180 days following the last dose of trial medication
* Females breastfeeding or pregnant (positive blood pregnancy test prior to receiving trial drug)
* Risk of committing suicide
* Abnormal laboratory test results, vital signs and ECG results
* Participated in any clinical trial other than Trial 250 with an investigational agent within the 30 days prior to screening
* Had electroconvulsive therapy (ECT) treatment during the current episode or within 3 months
* Subjects who have not met criteria for stabilization for 4 consecutive weeks