Long-term Study of FK949E in Elderly Bipolar Disorder Patients
Condition: Bipolar Disorder; Elderly
MeSH terms: Bipolar Disorder
Intervention: FK949E
Intervention description: Oral tablet
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: patients; Major depressive episode; FK949E

Summary:

      FK949E was administered to elderly bipolar disorder patients with major depressive episode
      for 52 weeks. Its safety, efficacy, and plasma concentration change were evaluated in an
      open-label manner.
    

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

          -  Male subjects must agree to take appropriate contraceptive measures with condoms
             during the study period.

          -  Female subjects must be confirmed to have no childbearing potential during the study
             period

        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 was 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 more than 12 months or 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 primary
             registration.

          -  Unable to suspend antipsychotics or antidepressants after primary registration

          -  Treatment with two or more of mood stabilizers (lithium carbonate and/or sodium
             valproate) and lamotrigine, if these drugs, except one of either drug, cannot be
             suspended after primary registration.

          -  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 primary registration

          -  Electroconvulsive therapy within the last 83 days before primary registration.

          -  A possible need of psychotherapy during the study period (unless the therapy has been
             commenced at least 83 days before primary registration).

          -  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