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Effect of Nuvigil on Fatigue

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Menopause

Intervention: Armodafinil (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Hadine Joffe, MD, MSc, Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Hadine Joffe, MD, MSc, Phone: 617-724-1849, Email: hjoffe@partners.org

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.

Clinical Details

Official title: The Effect of Armodafinil (Nuvigil) on Fatigue and Quality of Life in Peri- and Postmenopausal Women

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Menopause Quality Of Life Questionnaire (MENQOL) Physical subscale

Brief Fatigue Inventory (BFI)

Secondary outcome:

Sleepiness

Hot flash frequency and severity

Anxiety symptoms

Depressive symptoms

Cognitive problems

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

Minimum age: 40 Years. Maximum age: 65 Years. Gender(s): Female.

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

Locations and Contacts

Hadine Joffe, MD, MSc, Phone: 617-724-1849, Email: hjoffe@partners.org

Center for Women's Mental Health, Boston, Massachusetts 02114, United States; Recruiting
Maria M Barsky, BA, Phone: 617-724-6540, Email: mbarsky@partners.org
Additional Information

Starting date: October 2011
Last updated: March 21, 2013

Page last updated: August 23, 2015

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