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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01460628 |
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Date of registration:
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25/10/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Nuvigil on Fatigue
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Scientific title:
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The Effect of Armodafinil (Nuvigil) on Fatigue and Quality of Life in Peri- and Postmenopausal Women |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01460628 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Hadine Joffe, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Brigham and Women's Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Menopause
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Intervention(s)
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Drug: Armodafinil
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Primary Outcome(s)
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Menopause Quality Of Life Questionnaire (MENQOL) Physical Domain Subscale
[Time Frame: 4 weeks]
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Brief Fatigue Inventory (BFI)
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Symptom Checklist-10 Anxiety
[Time Frame: 4 weeks]
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Brown Attention Deficit Disorder Scale (BADDS)
[Time Frame: 4 weeks]
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Hot Flash Frequency (24-hr Period)
[Time Frame: 4 weeks]
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Epsworth Sleepiness Scale (ESS)
[Time Frame: 4 weeks]
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Patient Health Questionnaire-9 (PHQ-9)
[Time Frame: 4 weeks]
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Secondary ID(s)
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2011P-001055
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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