Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder
Condition: Bipolar I
Intervention: Aripiprazole
Intervention description: 400mg or 300mg, intramuscular injections every 4 weeks.
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 748.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Aripiprazole, Intramuscular (IM) Depot, Bipolar

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.
    

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