Conditions: Bipolar I Disorder
Keywords: Aripiprazole Intramuscular (IM) Depot Bipolar
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 731
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Active Comparator: Treatment of Aripiprazole IM Depot arm 2: Placebo Comparator: Treatment of IM Depot Placebo

Interventions: intervention 1: Intramuscular (IM) Depot Aripiprazole intervention 2: Intramuscular (IM) Depot Placebo
Intervention descriptions: intervention 1: Formulation: Intramuscular (IM) Depot Aripiprazole Formulation 400 mg or 300 mg, once a month injection intervention 2: Formulation: Intramuscular (IM) Depot Placebo 400 mg or 300 mg, once a month injection

Protocol document: