Effect of Nuvigil on Fatigue
Completed · Phase 4 · Has a placebo group
Conditions studied: Menopause
In brief
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.
Key facts
- Study ID
- NCT01460628
- Run by
- Massachusetts General Hospital
- People needed
- 25
- Starts
- 2011-10-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2017-03-15
Who can join
Age: 40 and older, up to 65. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Women
- Ages 40-65
- Peri- and postmenopausal
- Suffering from fatigue
- Experiencing hot flashes(Not required for perimenopausal women)
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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