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Effect of Nuvigil on Fatigue

This study has been completed.
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Hadine Joffe, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01460628
First received: October 25, 2011
Last updated: January 25, 2017
Last verified: January 2017
  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: Intervention Model: Single Group Assignment
Masking: No masking
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 Hadine Joffe, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Menopause Quality Of Life Questionnaire (MENQOL) Physical Domain Subscale [ Time Frame: 4 weeks ]
    This is a widely used self-report instrument to determine differences in quality of life among menopausal women and to measure changes in their quality of life over time. Four domain scores are calculated from the 29-item instrument. The physical domain subscale has 16 questions and a range from 0-8 with higher scores indicating worse symptoms.

  • Brief Fatigue Inventory (BFI) [ Time Frame: 4 weeks ]
    This is a widely used self-report instrument to assess the severity of fatigue and the impact of fatigue on daily functioning. This 9 item instrument yields a global fatigue score ranging from 0-10 with higher scores indicating worse symptoms. .


Secondary Outcome Measures:
  • Epsworth Sleepiness Scale (ESS) [ Time Frame: 4 weeks ]
    This self-report scale is widely used as a subjective measure of sleepiness. This 8 item instrument yields a total score ranging from 0-24 with higher scores indicating worse symptoms.

  • Hot Flash Frequency (24-hr Period) [ Time Frame: 4 weeks ]
    The Daily Vasomotor Symptom Diary consists of a 7-day scale on which the subject records the total number of hot flushes they experience on a daily basis. Weekly averages for a 24-hour period are calculated.

  • Symptom Checklist-10 Anxiety [ Time Frame: 4 weeks ]
    The SCL-10 anxiety subscale, developed from the refinement of the Hopkins Symptom Checklist (HSCL), consists of 10 questions focused on how much discomfort symptoms of anxiety (e.g. "nervousness or shaking inside") have caused in the past two weeks. Each question is answered on a scale from 0-4, and answers are averaged for a total score between 0-4 with higher scores indicating more anxiety.

  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 4 weeks ]
    The PHQ-9 is the self-administered form of the Primary Care Evaluation of Mental Disorders (PRIME-MD), a widely used instrument designed to screen for psychiatric illnesses in primary-care settings. This 9-item instrument assesses mood, depressive symptoms, and suicidal ideation. The range of total scores is 0-27 with higher scores indicating worse symptoms. Generally, scores 5-9 indicate mild depression, 10-14 indicate moderate depression, and 15+ indicate moderately severe or severe depression.

  • Brown Attention Deficit Disorder Scale (BADDS) [ Time Frame: 4 weeks ]
    This is a normed and validated measure of ADHD-related executive function impairments. The clinician administered scale measures five clusters of executive function including 1) organizing and activating for work, 2) sustaining attention and concentration, 3) sustaining alertness, effort, and processing speed, 4) managing affective interference, and 5) using working memory and accessing recall. The frequency and severity of each of the 40 items is rated on a scale of 0 to 3, with the total scores ranging from 0-120 and higher scores indicating worse symptoms.


Enrollment: 25
Study Start Date: October 2011
Study Completion Date: December 2013
Primary Completion Date: May 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. 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.
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   (Adult)
Sexes 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

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Hadine Joffe, MD, MSc Brigham and Women's Hospital
  More Information

Responsible Party: Hadine Joffe, MD, Vice Chair for Research, Psychiatry Department, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01460628     History of Changes
Other Study ID Numbers: 2011P-001055
Study First Received: October 25, 2011
Results First Received: July 12, 2016
Last Updated: January 25, 2017

Keywords provided by Hadine Joffe, MD, Brigham and Women's 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
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 26, 2017