Overview

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

Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lehigh Valley Hospital
Collaborator:
Takeda
Criteria
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.

Exclusion Criteria:

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
corticosteroids.

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.