Effect of Nuvigil on Fatigue

Mass General Brigham

Status and phase

Completed

Phase 4

Conditions

Menopause

Treatments

Drug: Armodafinil

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01460628

2011P-001055

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

Female

Ages

40 to 65 years old

Volunteers

Accepts Healthy Volunteers

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