Status:
COMPLETED
Effect of Nuvigil on Fatigue
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Teva Pharmaceuticals USA
Conditions:
Menopause
Eligibility:
FEMALE
40-65 years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
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 associ...
Eligibility Criteria
Inclusion
- Women
- Ages 40-65
- Peri- and postmenopausal
- Suffering from fatigue
- Experiencing hot flashes(Not required for perimenopausal women)
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01460628
Start Date
October 1 2011
End Date
December 1 2013
Last Update
March 15 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114