Effect of Nuvigil on Fatigue (NCT01460628) | Clinical Trial Compass
CompletedPhase 4
Effect of Nuvigil on Fatigue
United States25 participantsStarted 2011-10
Plain-language 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.
Who can participate
Age range40 Years – 65 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Menopause Quality Of Life Questionnaire (MENQOL) Physical Domain Subscale