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 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.

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