Overview

Effect of Nuvigil on Fatigue

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Massachusetts General Hospital
Collaborator:
Teva Pharmaceuticals USA
Treatments:
Armodafinil
Modafinil
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