Effect of Nuvigil on Fatigue
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.
|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|
- 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.
- 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.
|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)|
Armodafinil is the drug being tested.
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460628
|Contact: Hadine Joffe, MD, MScfirstname.lastname@example.org|
|Contact: Maria M Barsky, BAemail@example.com|
|United States, Massachusetts|
|Center for Women's Mental Health||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Maria M Barsky, BA 617-724-6540 firstname.lastname@example.org|
|Principal Investigator:||Hadine Joffe, MD, MSc||Massachusetts General Hospital|