The Effect of Armodafinil (Nuvigil) on Fatigue and Quality of Life in Peri- and Postmenopausal Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Menopause Quality Of Life Questionnaire (MENQOL) Physical Domain Subscale
研究概览
简要总结
The purpose of this study is to determine if armodafinil improves quality of life and is an effective treatment of fatigue in symptomatic perimenopausal and postmenopausal women.
详细描述
Fatigue is one of the most prevalent symptoms occurring in peri- and postmenopausal women. It is strongly associated with reduced quality of life in this population. Studies have shown a strong association between fatigue and menopausal symptoms such as hot flashes, vaginal symptoms, and sexual dysfunction. Because sleep disturbance commonly co-occurs in women with hot flashes as a result of nocturnal hot flashes disrupting sleep, sleep disturbance may explain the association between hot flashes and fatigue in this population. However evidence suggests that fatigue can occur in the absence of sleep disruption, indicating that sleep problems do not exclusively explain the etiology of fatigue in this population.
Armodafinil is a wakefulness-promoting agent that acts as a central nervous system stimulant. It is chemically and pharmacologically unrelated to other CNS stimulants, such as methylphenidate and amphetamine. Armodafinil is FDA approved to increase wakefulness in patients with excessive sleepiness due to narcolepsy, obstructive sleep apnea, and shift work sleep disorder. It has not be studied in menopause-associated fatigue.
In the proposed study, the investigators plan to investigate the effect of armodafinil on quality of life and fatigue in a population of peri- and postmenopausal women with fatigue and reduced quality of life who do not have primary sleep disorders, significant levels of insomnia, or depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ages 40-65
- •Peri- and postmenopausal
- •Suffering from fatigue
- •Experiencing hot flashes(Not required for perimenopausal women)
排除标准
- •Current episode of major depression
- •Moderate-to-severe insomnia
- •Night shift workers
- •Previous diagnosis of manic depressive disorder, psychotic disorder, or psychotic symptoms
- •Suicidal ideation
- •Alcohol/drug abuse
- •Concern about potential misuse of study medication
- •Use of prescribed medications to treat insomnia or other sleep disturbance symptoms
- •Pregnant or breastfeeding
- •Use of systemic menopausal hormonal therapy or birth control
- •Use of centrally active medications, such as antidepressants, anxiolytics, and hypnotics agents
- •Use of clopidogrel
- •Use of atomoxetine
- •Cardiovascular contraindications of use of armodafinil
研究组 & 干预措施
Armodafinil
Armodafinil is the drug being tested.
干预措施: Armodafinil (Drug)
结局指标
主要结局
Menopause Quality Of Life Questionnaire (MENQOL) Physical Domain Subscale
时间窗: 4 weeks
This is a widely used self-report instrument to determine differences in quality of life among menopausal women and to measure changes in their quality of life over time. Four domain scores are calculated from the 29-item instrument. The physical domain subscale has 16 questions and a range from 0-8 with higher scores indicating worse symptoms.
Brief Fatigue Inventory (BFI)
时间窗: 4 weeks
This is a widely used self-report instrument to assess the severity of fatigue and the impact of fatigue on daily functioning. This 9 item instrument yields a global fatigue score ranging from 0-10 with higher scores indicating worse symptoms. .
次要结局
- Patient Health Questionnaire-9 (PHQ-9)(4 weeks)
- Brown Attention Deficit Disorder Scale (BADDS)(4 weeks)
- Epsworth Sleepiness Scale (ESS)(4 weeks)
- Hot Flash Frequency (24-hr Period)(4 weeks)
- Symptom Checklist-10 Anxiety(4 weeks)
研究者
Hadine Joffe, MD
Vice Chair for Research, Psychiatry Department
Brigham and Women's Hospital