Clinical trial NCT01460628: Effect of Nuvigil on Fatigue
Official title: The Effect of Armodafinil (Nuvigil) on Fatigue and Quality of Life in Peri- and Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menopause
Keywords: fatigue
menopausal symptoms
hot flashes
Vasomotor symptoms
perimenopause
related Quality of life
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Teva Pharmaceuticals USA
First posted: 2011-10-27
Enrollment: 25
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 association between fatigue and menopausal symptoms such as hot flashes, vaginal symptoms, and sexual dysfunction. Because sleep disturbance commonly co-occurs in women with hot flashes as a result of nocturnal hot flashes disrupting sleep, sleep disturbance may explain the association between hot flashes and fatigue in this population. However evidence suggests that fatigue can occur in the absence of sleep disruption, indicating that sleep problems do not exclusively explain the etiology of fatigue in this population.

Armodafinil is a wakefulness-promoting agent that acts as a central nervous system stimulant. It is chemically and pharmacologically unrelated to other CNS stimulants, such as methylphenidate and amphetamine. Armodafinil is FDA approved to increase wakefulness in patients with excessive sleepiness due to narcolepsy, obstructive sleep apnea, and shift work sleep disorder. It has not be studied in menopause-associated fatigue.

In the proposed study, the investigators plan to investigate the effect of armodafinil on quality of life and fatigue in a population of peri- and postmenopausal women with fatigue and reduced quality of life who do not have primary sleep disorders, significant levels of insomnia, or depression.

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

Primary outcomes:
measure: Menopause Quality Of Life Questionnaire (MENQOL) Physical Domain Subscale
timeFrame: 4 weeks
measure: Brief Fatigue Inventory (BFI)
timeFrame: 4 weeks
Secondary outcomes:
measure: Epsworth Sleepiness Scale (ESS)
timeFrame: 4 weeks
measure: Hot Flash Frequency (24-hr Period)
timeFrame: 4 weeks
measure: Symptom Checklist-10 Anxiety
timeFrame: 4 weeks
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 4 weeks
measure: Brown Attention Deficit Disorder Scale (BADDS)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Hadine Joffe, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: