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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborator: H. Lundbeck A/S
• Treatments: Aripiprazole

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