Effect of Nuvigil on Fatigue

NCT ID: NCT01460628

Last Updated: 2017-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-12-31

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.

Conditions

Menopause

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Armodafinil

Armodafinil is the drug being tested.

Group Type: EXPERIMENTAL

Armodafinil

Intervention Type: DRUG

Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio. No primary outcomes were studied in the discontinuation phase.

Interventions

Armodafinil

Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio. No primary outcomes were studied in the discontinuation phase.

Intervention Type: DRUG

Other Intervention Names

Nuvigil

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hadine Joffe, MD

Vice Chair for Research, Psychiatry Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hadine Joffe, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2011P-001055

Identifier Type: -

Identifier Source: org_study_id