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

Completed · Phase 4 · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

The purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.

Key facts

Study ID

NCT00552760

Run by

Lehigh Valley Hospital

People needed

90

Starts

2007-11-01

Expected to finish

2010-05-01

Last updated by the study team

2014-04-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of written informed consent before initiation of any study-related procedures
• Men and women aged 18 to 65 years.
• 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.
• PSQI total score of >=5.
• MADRS total score of <=12.
• YMRS total score of <= 12
• 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.
• Be able to understand and comply with the requirements of the study, as judged by the investigator.
• Outpatient status at enrollment.

You may not qualify if…

• Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status.
• Presence of prohibited medications of antidepressants (including MAOI's) and systemic corticosteroids.
• Patients with a diagnosis of primary insomnia disorders
• Patients with a diagnosis of severe chronic obstructive pulmonary disease
• 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.
• Patients with active substance abuse diagnoses (except tobacco abuse).
• Known history of intolerance or hypersensitivity to ramelteon or to any other component in the tablet.

Where it is running

• Lehigh Valley Hospital, Department of Psychiatry — Allentown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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