Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex
Condition: Bipolar I Disorder
Intervention: Lurasidone; Placebo
Intervention description: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter; 20-80 mg flexible dose
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 965.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lurasidone; Latuda; Bipolar I

Summary:

      This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study
      designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or
      divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without
      rapid cycling and /or psychotic features.
    

Eligibility criteria:

        Inclusion Criteria:

        Open-label Phase

          -  18 years of age or older

          -  Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision
             (DSM-IV-TR) diagnosis of bipolar I disorder

             •≥ 1 manic, mixed manic, or depressed episode in past 2 years

          -  YMRS or MADRS total score ≥ 14 if on lithium or divalproex; ≥ 18 if not on lithium or
             divalproex

        Double-blind Phase

        Inclusion Criteria:

          -  Subjects must achieve consistent clinical stability, defined as total scores ≤ 12 on
             the YMRS and MADRS over at least 12 weeks, with the allowance of two excursions (YMRS
             and/or MADRS total scores up to 13 or 14, respectively) except during the last 4 weeks
             before randomization

        Exclusion Criteria:

        Open Label Phase

          -  Diagnosis of an Axis I or Axis II disorder, other than bipolar I disorder, that is the
             primary focus of treatment within 3 months of screening

          -  Subjects for whom diagnostic agreement between the Investigator and United BioSource
             Corporation (Boston) (UBC) cannot be reached

          -  Ultra-fast rapid cycling (defined as ≥ 8 mood episodes over the previous 12-month
             period)

          -  Subjects who test positive for drugs of abuse at screening. In the event a subject
             tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate
             the subject's ability to abstain from cannabis during the study

          -  Unstable/inadequately treated medical illness

          -  The subjects answers "yes" to "Suicidal Ideation" items 4 or 5 on the C-SSRS (at time
             of evaluation)

        Double Blind Phase

          -  Subjects who in the Investigator's judgment have not been compliant with study
             medication during the stabilization phase

          -  Subjects who have not stabilized during the open-label phase (within 20 weeks)

          -  Subjects who test positive for drugs of abuse at double-blind phase baseline. In the
             event a subject tests positive for cannabinoids (tetrahydrocannabinol), the
             Investigator will evaluate the subject's ability to abstain from cannabis during the
             study