Effect of Nuvigil on Fatigue

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01460628
• Other study ID #: 2011P-001055
• Status: Recruiting
• Phase: Phase 4
• First received: October 25, 2011
• Last updated: March 21, 2013
• Start date: October 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2013
• Source: Massachusetts General Hospital
• Contact: Hadine Joffe, MD, MSc
• Phone: 617-724-1849
• Email: hjoffe[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Menopause

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Women's Mental Health	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Teva Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menopause Quality Of Life Questionnaire (MENQOL) Physical subscale	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.	4 weeks	No
Primary	Brief Fatigue Inventory (BFI)	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.	4 weeks	No
Secondary	Sleepiness	The Epsworth Sleepiness Scale(ESS) will be used in an exploratory fashion to assess changes in sleepiness.	4 weeks	No
Secondary	Hot flash frequency and severity	Hot flash diaries will be used in an exploratory fashion to measure changes in hot flash frequency and severity.	4 weeks	No
Secondary	Anxiety symptoms	The Symptom Checklist-10 Anxiety items (SCL-10) will be used in an exploratory fashion to measure changes in anxiety symptoms.	4 weeks	No
Secondary	Depressive symptoms	The Beck Depression Inventory (BDI) will be used in an exploratory fashion to measure changes in depressive symptoms.	4 weeks	No
Secondary	Cognitive problems	The Brown Attention Deficit Disorder Scale will be used in an exploratory fashion to measure changes in cognitive symptoms.	4 weeks	No