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

Completed · Phase 3

Conditions studied: Bipolar I

In brief

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.

Key facts

Study ID

NCT01710709

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

748

Starts

2012-11-01

Expected to finish

2016-12-01

Last updated by the study team

2018-09-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Rogers, Arkansas, United States
• Study site — Bellflower, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Costa Mesa, California, United States
• Study site — Culver City, California, United States
• Study site — Garden Grove, California, United States
• Study site — Lemon Grove, California, United States
• Study site — Oakland, California, United States
• Study site — Orange, California, United States
• Study site — Pico Rivera, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — Temecula, California, United States
• Study site — Upland, California, United States
• Study site — Wildomar, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Gainesville, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Leesburg, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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