Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT00552760
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00552760
Study Brief:
Protocol Section:
NCT00552760