Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder (Ram-TIME)
The purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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.|
- Pittsburgh Sleep Quality Index (PSQI) Global Score [ Time Frame: Monthly for 6 months ] [ Designated as safety issue: No ]Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Scores range from 0-21, higher scores represent more significant sleep disturbance.
- Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Monthly for 6 months ] [ Designated as safety issue: No ]10-item, standardized, well-validated scale used to measure severity of depressive symptoms; sensitive to treatment effects in depressed outpatients. Scores range from 0-60, higher scores represent more severe depressive symptoms.
- Young Mania Rating Scale (YMRS) Total Score [ Time Frame: Monthly for 6 months ] [ Designated as safety issue: No ]11-item standardized, well-validated scale used to measure manic symptoms; sensitive to treatment effects in manic patients. Scores range from 0-60, higher scores represent more severe manic symptoms.
- Clinical Global Impressions Bipolar Version(CGI-BP) Severity of Illness Overall Score [ Time Frame: Monthly for 6 months ] [ Designated as safety issue: No ]3-part (mania, depression, overall bipolar illness), physician-administered scale used to assess global illness severity; used to measure change. Each part is rated from 1-7, higher scores represent more severe mental illness. Only overall bipolar rating was used.
- Cumulative Proportion of Participants in Each Arm Surviving Without Relapse [ Time Frame: Monthly for 6 months ] [ Designated as safety issue: No ]Survival analysis techniques, including Kaplan Meier curves, were used to evaluate group differences in time to relapse. Relapse was defined as a medication initiation or change for manic/depressed/mixed symptoms, a hospitalization for manic/depressed/mixed symptoms, MADRS score >= 16, YMRS score > 14, and suicide risk or imminent risk of suicide. Time to relapse was measured discretely in terms of the number of assessment visits until discontinued from the study.
|Study Start Date:||November 2007|
|Study Completion Date:||May 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
one 8 mg tablet at bedtime for up to 6 months
Other Name: Rozerem
|Placebo Comparator: Placebo||
one tablet at bedtime for up to 6 months
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.
|United States, Pennsylvania|
|Lehigh Valley Hospital, Department of Psychiatry|
|Allentown, Pennsylvania, United States, 18103|
|Principal Investigator:||Edward R. Norris, MD||Lehigh Valley Hospital|