Long-term Study of FK949E in Elderly Bipolar Disorder Patients

Inclusion Criteria:

• Diagnosis of bipolar I or II disorder as specified in the Diagnostic and StatisticalManual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR), with a majordepressive episode

• Able to participate in the study with understanding of and compliance with subjectrequirements during the study in the investigator's or subinvestigator's opinion

• Male subjects must agree to take appropriate contraceptive measures with condomsduring the study period.

• Female subjects must be confirmed to have no childbearing potential during the studyperiod

Exclusion Criteria:

• Concurrent or previous history of DSM-IV-TR Axis I disorders, except bipolardisorder, within the last 6 months before informed consent

• Concurrence of DSM-IV-TR Axis II disorder that was considered to greatly affectpatient'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 forthe current major depressive episode in the investigator's or subinvestigator'sopinion

• 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 abuseor dependence.

• Treatment with a depot antipsychotic within the last 49 days before primaryregistration.

• Unable to suspend antipsychotics or antidepressants after primary registration

• Treatment with two or more of mood stabilizers (lithium carbonate and/or sodiumvalproate) and lamotrigine, if these drugs, except one of either drug, cannot besuspended 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 asconditionally-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 hasbeen 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 therisk of suicide in the investigator's or subinvestigator's opinion