Phase 4
Completed N=25
Effect of Nuvigil on Fatigue
Source: ClinicalTrials.gov NCT01460628 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Menopause Quality Of Life Questionnaire (MENQOL) Physical Domain Subscale — 1.9 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Menopause Quality Of Life Questionnaire (MENQOL) Physical Domain Subscale |
1.9 | — |
| PRIMARY Brief Fatigue Inventory (BFI) |
2.2 | — |
| SECONDARY Epsworth Sleepiness Scale (ESS) |
3.0 | — |
| SECONDARY Hot Flash Frequency (24-hr Period) |
1.5 | — |
| SECONDARY Symptom Checklist-10 Anxiety |
— | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
3.0 | — |
| SECONDARY Brown Attention Deficit Disorder Scale (BADDS) |
15.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01460628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.