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