The purpose of this study is to determine whether treating sleep difficulties in patients
with bipolar disorder also improves their mood stability.
Patients with euthymic bipolar disorder, although free of significant mood symptoms, often
have continued sleep disturbances. Improving patients' sleep by also normalizing the
circadian rhythm will lead to fewer mood exacerbations. Ramelteon offers a new and more
pharmacologically exact mechanism to re-synchronize the SCN. The administration of ramelteon
for bipolar patients will improve sleep and will cause fewer mood exacerbations.
Patients with bipolar disorder often experience frequent mood alterations that are attempted
to be controlled by mood stabilizing agents and anti-psychotic agents. Both classes of
medications have numerous significant side effects. Establishing that ramelteon is helpful
in the sleep of patients with bipolar disorder and helpful in mood stability will increase
the number of treatment options for bipolar patients.
1. Provision of written informed consent before initiation of any study-related
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
9. Outpatient status at enrollment.
1. Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the
patient's current psychiatric status.
2. Presence of prohibited medications of antidepressants (including MAOI's) and systemic
3. Patients with a diagnosis of primary insomnia disorders
4. Patients with a diagnosis of severe chronic obstructive pulmonary disease
5. A clinical finding that is untreated (eg, hypertension, poorly controlled diabetes,
angina) or that, in the opinion of the investigator, would be negatively affected by
the study medication or that would affect the study medication.
6. Patients with active substance abuse diagnoses (except tobacco abuse).
7. Known history of intolerance or hypersensitivity to ramelteon or to any other
component in the tablet.