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.
Key Inclusion Criteria:
- Male and female subjects 18 to 65 years of age, inclusive, at time of informed consent.
- Subjects with a current diagnosis of bipolar I disorder, as defined by DSM-IV-TR criteria and confirmed by the MINI, who have experienced at least 1 previous manic episode of sufficient severity to require hospitalization and/or treatment with a mood stabilizer or antipsychotic agent, in addition to their most recent episode. Rapid cyclers with 8 or less episodes in the previous year will be included.
- Subjects currently experiencing a manic episode with a YMRS total score of ≥20 at the Screening Visit.
- Subjects can have an inpatient or outpatient status prior to entry into Phase C (IM depot stabilization).
- In the investigator's opinion, subjects who are able to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, aripiprazole IM depot injection, and discontinuation of prohibited concomitant medications; who can read and understand the written word in order to complete subject-reported outcomes measures; and who can be reliably rated on assessment scales.
Qualified Participants May Receive:
Investigational medication and all study related visits at no cost. Possible compensation for each completed visit.