Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients

Study Summary

This will be a randomized, double-blind, placebo-controlled trial to assess the time to recurrence of any mood episode in subjects with bipolar I disorder who have maintained stability on aripiprazole IM depot for at least 8 weeks. This trial will include male and female subjects 18 to 65 years of age, inclusive, with a diagnosis of bipolar I disorder, according to DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI), who have experienced at least one previous manic episode of sufficient severity to require hospitalization and/or treatment with a mood stabilizer or antipsychotic agent in addition to their current manic episode. All subjects must be experiencing a manic episode (per DSM-IV-TR criteria) with a YMRS total score ≥ 20 at trial entry. Both inpatients and outpatients are eligible for this trial. This trial will consist of a screening phase followed by 4 treatment phases. Subjects will undergo screening for eligibility, followed by a conversion to oral aripiprazole monotherapy phase, if needed, an oral aripiprazole stabilization phase, a single-blind aripiprazole IM depot stabilization phase, and, a double-blind, placebo-controlled phase.

Primary Outcome

This endpoint was defined as meeting any of the following criteria: 1. Hospitalization for any mood episode OR 2. Any of the following: 1. YMRS total score ≥ 15 OR 2. MADRS total score ≥ 15 OR 3. CGI-BP-S score \> 4 (overall score) OR 3. SAE of worsening disease (bipolar I disorder) OR 4. Discontinuation due to lack of efficacy or discontinuation due to an AE of worsening disease OR 5. Clinical worsening with the need for treatment of symptoms of an underlying mood disorder by additio

Interventions

• DRUG Intramuscular (IM) Depot Aripiprazole
• DRUG Intramuscular (IM) Depot Placebo