Effect of Nuvigil on Fatigue
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 40 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | October 2011 |
| End Date: | December 2013 |
| Contact: | Hadine Joffe, MD, MSc |
| Email: | hjoffe@partners.org |
| Phone: | 617-724-1849 |
The Effect of Armodafinil (Nuvigil) on Fatigue and Quality of Life in Peri- and Postmenopausal Women
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.
effective treatment of fatigue in symptomatic perimenopausal and postmenopausal women.
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.
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.
Inclusion Criteria:
Women
- Ages 40-65
- Peri- and postmenopausal
- Suffering from fatigue
- Experiencing hot flashes(Not required for perimenopausal women)
Exclusion Criteria:
- 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
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