A Double-Blind, Randomized, Placebo-Controlled Trial of Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI) Global Score
研究概览
简要总结
The purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >=
- •MADRS total score of <=
- •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.
排除标准
- •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.
研究组 & 干预措施
Ramelteon
8 mg
干预措施: Ramelteon (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI) Global Score
时间窗: Monthly for 6 months
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.
次要结局
- Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Monthly for 6 months)
- Young Mania Rating Scale (YMRS) Total Score(Monthly for 6 months)
- Clinical Global Impressions Bipolar Version(CGI-BP) Severity of Illness Overall Score(Monthly for 6 months)
- Cumulative Proportion of Participants in Each Arm Surviving Without Relapse(Monthly for 6 months)
研究者
Edward R. Norris, MD
Physician-Investigator
Lehigh Valley Hospital