Effect of Nuvigil on Fatigue

Phase 4

Completed

Conditions: Menopause

Interventions: Drug: Armodafinil

Registration Number: NCT01460628

Lead Sponsor: Massachusetts General Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 25

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Armodafinil	Armodafinil	Armodafinil is the drug being tested.

Primary Outcome Measures

Name	Time	Method
Menopause Quality Of Life Questionnaire (MENQOL) Physical Domain Subscale	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)	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

Name	Time	Method
Patient Health Questionnaire-9 (PHQ-9)	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)	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.
Epsworth Sleepiness Scale (ESS)	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)	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	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.