Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder
Condition: Bipolar Disorder Mania
MeSH terms: Mania; Bipolar Disorder
Intervention: Aripiprazole; Placebo; Lithium; Valproate
Intervention description: 5-, 10-, or 15-mg oral tablets in titrated doses for 12 weeks; Tablets, Oral, 0 mg, once daily, 12 weeks; Participant's ongoing dose; Participant's ongoing dose
Intervention MeSH terms: Valproic Acid; Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 493.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine whether aripiprazole provides additional clinical
      benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12
      weeks.
    

Eligibility criteria:

        Key inclusion criteria:

          -  Clinical diagnosis of bipolar I disorder mania, manic or mixed episode, with or
             without psychotic features

          -  Current ongoing lithium or valproate treatment with the possibility of benefiting,
             based on the investigator's clinical judgment, from adjunctive treatment with
             aripiprazole

          -  Therapeutic serum levels of lithium or valproate and a Young Mania Rating Total Score
             of 16 or higher at screening and baseline

          -  Participants taking current lithium or valproate treatment combined with antipsychotic
             medication other than aripiprazole are acceptable, provided that the other
             antipsychotic medication is washed out at least 3 days prior to the blood draw for
             therapeutic plasma levels of lithium and valproate determination. Long-acting
             antipsychotics must be washed out prior to entering the double-blind treatment.

        Key exclusion criteria:

          -  Women of childbearing potential who are unwilling or unable to use an acceptable
             method to avoid pregnancy for the entire study period and for up to 4 weeks after the
             last dose of investigational product

          -  A diagnosis of delirium, dementia, amnesia or other cognitive disorder, or a psychotic
             disorder

          -  Current diagnosis of delirium, dementia, a cognitive disorder (ie, amnesia), or a
             psychotic disorder (ie, schizophrenia or schizoaffective disorder)

          -  Current diagnosis of bipolar II disorder, bipolar disorder not otherwise specified, or
             any other primary psychiatric disorder other than bipolar I disorder mania

          -  Thyroid pathology

          -  Demonstrated cocaine abuse or dependence within the past 3 months prior to screening.

          -  History of neuroleptic malignant syndrome from antipsychotic agents

          -  Manic symptoms that investigator considers refractory to treatment

          -  Previous nonresponsive (by investigator judgment) to aripiprazole for manic symptoms

          -  Significant risk of suicide based on history, mental status exam, or investigator
             judgment.