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

Condition(s) targeted: Bipolar Disorder

Intervention: Ramelteon (Drug); placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Lehigh Valley Hospital

Official(s) and/or principal investigator(s):
Edward R. Norris, MD, Principal Investigator, Affiliation: Lehigh Valley Hospital

Overall contact:
Karen Burke, RN, BSN, Phone: 610-402-5714, Email: karen.burke@lvh.com

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

Official title: A Double-Blind, Randomized, Placebo Controlled Trial of Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder.

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: The primary variable measured will be the change from randomization in Pittsburgh Sleep Quality Index (PSQI) global score.

Secondary outcome:

the change from randomization in MADRS total score

the change from randomization in YMRS total score

the mean change from randomization in CGI-BP severity of illness score

the occurrence of a manic or depressed event as evidenced by a YMRS score => 14 and/or a MADRS => 16 for 2 consecutive weeks, hospitalization for manic/depressed symptoms, initiation of pharmacologic treatment for manic/depressed symptoms

Detailed description: 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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Karen Burke, RN, BSN, Phone: 610-402-5714, Email: karen.burke@lvh.com

Lehigh Valley Hospital, Department of Psychiatry, Allentown, Pennsylvania 18103, United States; Recruiting
Karen Burke, RN, BSN, Phone: 610-402-5714, Email: karen.burke@lvh.com
Edward R Norris, MD, Principal Investigator

Starting date: November 2007
Ending date: December 2009
Last updated: January 29, 2009