Eszopiclone in the Treatment of Insomnia and Associated Symptoms of Fibromyalgia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Total Sleep Time (TST) as Recorded in Patient Diaries
研究概览
简要总结
The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia. It is hypothesized that participants receiving eszopiclone will report greater improvement in total sleep time, sleep quality, pain, fatigue, physical functioning, and emotional distress than will those receiving placebo.
详细描述
Fibromyalgia (FM) is a prevalent, debilitating, and costly syndrome. Although the pathophysiology of FM is not yet well-understood, sleep disturbance is a prominent feature of most theories. Eszopiclone has been approved by the FDA for the treatment of insomnia, but has not been studied in the treatment of FMS. The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia (FMS) in FMS patients. Participants will be randomly selected to receive eszopiclone or placebo. It is hypothesized that participants receiving eszopiclone will report greater improvement in total sleep time, sleep quality, pain, fatigue, physical functioning, and emotional distress than will those receiving placebo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18 through
- •Meets ACR criteria for FMS, as determined by rheumatological examination and a medical history review.
- •Reports sleep maintenance insomnia (total sleep time of < 6.5 hours or sleep impairment consisting of 3 of 7 nights per week for a month by history) or sleep onset latency insomnia (at least 3 of 7 nights of sleep latency > 30 minutes), as well as clinically significant daytime distress or impairment during the 1 week self assessment prior to baseline.
- •Has completed 8th grade and is fluent in English.
- •If a female of child bearing potential, the patient must be non-pregnant and either post-menopausal or using an approved birth control method. Acceptable birth control methods include: history of tubal ligation, having a male partner who is sterile, IUDs, birth control pills or other hormonal birth control methods (e.g., birth control patch, Depo-Provera injections), and double-barrier methods (e.g., condom and foam).
- •Antidepressant medication will be allowed if the patient has been on a stable dose for at least one month.
排除标准
- •Evidence of traumatic injury, inflammatory rheumatic disease, or infectious or endocrine-related arthropathy.
- •Evidence of a primary sleep disorder (e.g., significant sleep disordered breathing (central or obstructive apnea), periodic limb movement disorder, or REM sleep behavior disorder.
- •Any current, clinically significant medical condition.
- •Meets DSM-IV criteria for bipolar disorder, psychotic disorder, organic brain syndrome, or psychoactive substance abuse or dependence.
- •Any current psychiatric disorder that would interfere with study participation (investigator judgment).
- •Active suicidal ideation.
- •Plans to engage in additional psychotherapy during the study.
- •Concurrent use of benzodiazepines after 6pm or as a sleep aid.
- •Concurrent use of any other sleep aid.
- •Concurrent use of analgesics other than acetaminophen or non-steroidal anti-inflammatory medication.
- •Concurrent use of any medication that has not been stabilized for at least 1 month prior to screening.
研究组 & 干预措施
Eszopiclone
干预措施: Eszopiclone (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Change in Total Sleep Time (TST) as Recorded in Patient Diaries
时间窗: week 4
Difference in total sleep time between week 4 and baseline
次要结局
- Sleep Quality(week 12)
- Fibromyalgia Impact Questionnaire(week 12)
- Wake Time After Sleep Onset (WASO)(week 12)
- Clinician-rated Overall Severity of Fibromyalgia(week 12)
研究者
Lesley A. Allen, Ph.D.
Associate Professor of Psychiatry
University of Medicine and Dentistry of New Jersey