Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
Condition: Bipolar Depression
MeSH terms: Depression; Bipolar Disorder
Intervention: FK949E
Intervention description: A tablet containing 50 mg or 150 mg of quetiapine taken orally.
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: major depressive episodes; FK949E; quetiapine; bipolar depression; bipolar disorder

Summary:

      The purpose of this study was to evaluate the efficacy, safety, and pharmacokinetics of
      switching FK949E (sustained-release quetiapine) 50-mg and 150-mg tablets to the other tablet
      at the equivalent total daily dose in bipolar disorder patients with major depressive
      episodes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of bipolar I or II disorder as specified in the Diagnostic and Statistical
             Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR), with a major
             depressive episode.

          -  Able to participate in the study with understanding of and compliance with subject
             requirements during the study in the investigator's or subinvestigator's opinion.

        Exclusion Criteria:

          -  Concurrent or previous history of DSM-IV-TR Axis I disorders, except bipolar disorder,
             within the last 6 months before informed consent.

          -  Concurrence of DSM-IV-TR Axis II disorder that is considered to greatly affect
             patient's current mental status.

          -  The Young Mania Rating Scale (YMRS) total score of 13 points or more.

          -  Nine or more mood episodes within the last 12 months before informed consent.

          -  Lack of response to at least 6-week treatment with at least 2 antidepressants for the
             current major depressive episode in the investigator's or subinvestigator's opinion.

          -  The current major depressive episode persisting for less than 4 weeks before informed
             consent.

          -  History of substance dependence (other than caffeine and nicotine) or alcohol abuse or
             dependence.

          -  Treatment with a depot antipsychotic within the last 49 days before the start of the
             pre-treatment observation period.

          -  Unable to suspend antipsychotics or antidepressants after the start of the
             pre-treatment observation period.

          -  Treatment with more than one of the following three drugs, mood stabilizers (lithium
             carbonate and/or sodium valproate) and lamotrigine, if these drugs, except one of
             either drugs, cannot be suspended after the start of the pre-treatment observation
             period.

          -  Unable to suspend antiepileptics (except lamotrigine and sodium valproate),
             antianxiety agents, hypnotics, sedatives, psychostimulants, antiparkinsonian agents,
             cerebral ameliorators, antidementia agents, or anorectics, except those specified as
             conditionally-allowed concomitant drugs, from 7 days before the start of the
             pre-treatment observation period.

          -  Unable to suspend CYP3A4 inhibitors or inducers, or monoamine oxidase (MAO) inhibitors
             from 7 days before the start of the pre-treatment observation period.

          -  Electroconvulsive therapy within the last 83 days before the start of the
             pre-treatment observation period.

          -  A possible need of psychotherapy during the study period (unless the therapy has been
             commenced at least 83 days before the start of the pre-treatment observation period).

          -  The Hamilton Depression Rating Scale (HAM-D17) suicide score of 3 points or more,
             history of suicide attempt within the last 6 months before informed consent, or the
             risk of suicide in the investigator's or subinvestigator's opinion.