Effect of Nuvigil on Fatigue

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Hadine Joffe, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01460628
First received: October 25, 2011
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Menopause
Drug: Armodafinil
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Armodafinil (Nuvigil) on Fatigue and Quality of Life in Peri- and Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Menopause Quality Of Life Questionnaire (MENQOL) Physical subscale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    This is a widely used self-report scale measuring changes in quality of life of peri- and postmenopausal women. Four domain scores are calculated from the 29-item instrument: vasomotor, psychosocial, physical and sexual.

  • Brief Fatigue Inventory (BFI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    This is a widely used self-report scale to assess the severity of fatigue and the impact of fatigue on daily functioning. A global fatigue score can be obtained by averaging the 9 items on the BFI.


Secondary Outcome Measures:
  • Sleepiness [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The Epsworth Sleepiness Scale(ESS) will be used in an exploratory fashion to assess changes in sleepiness.

  • Hot flash frequency and severity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Hot flash diaries will be used in an exploratory fashion to measure changes in hot flash frequency and severity.

  • Anxiety symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The Symptom Checklist-10 Anxiety items (SCL-10) will be used in an exploratory fashion to measure changes in anxiety symptoms.

  • Depressive symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The Beck Depression Inventory (BDI) will be used in an exploratory fashion to measure changes in depressive symptoms.

  • Cognitive problems [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The Brown Attention Deficit Disorder Scale will be used in an exploratory fashion to measure changes in cognitive symptoms.


Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Armodafinil
Armodafinil is the drug being tested.
Drug: 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. 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.
Other Name: Nuvigil

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

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460628

Contacts
Contact: Hadine Joffe, MD, MSc 617-724-1849 hjoffe@partners.org
Contact: Maria M Barsky, BA 617-724-6540 mbarsky@partners.org

Locations
United States, Massachusetts
Center for Women's Mental Health Recruiting
Boston, Massachusetts, United States, 02114
Contact: Maria M Barsky, BA    617-724-6540    mbarsky@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Hadine Joffe, MD, MSc Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Hadine Joffe, MD, Director of Research at CWMH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01460628     History of Changes
Other Study ID Numbers: 2011P-001055
Study First Received: October 25, 2011
Last Updated: March 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
fatigue
menopausal symptoms
hot flashes
Vasomotor symptoms
perimenopause
related Quality of life

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Armodafinil
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014