Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder

Inclusion Criteria

• •1. Provision of written informed consent before initiation of any study-related procedures
• •2. Men and women aged 18 to 65 years.
• •3. A documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296.4x Bipolar I disorder, most recent episode manic, 296.6x Bipolar I disorder, most recent episode mixed, or 296.5x Bipolar I disorder, most recent episode depressed.
• •4. PSQI total score of \>=5.
• •5. MADRS total score of \<=12.
• •6. YMRS total score of \<= 12
• •7. Female patients of childbearing potential must have a negative urine pregnancy test at enrollment and be willing to use a reliable method of birth control, i.e., double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device or tubal ligation, during the study.
• •8. Be able to understand and comply with the requirements of the study, as judged by the investigator.
• •9. Outpatient status at enrollment.