Skip to main content
padlock icon - secure page this page is secure

Armodafinil for fatigue associated with menopause: an open-label trial

Buy Article:

$52.00 + tax (Refund Policy)

Objective:

This study aims to obtain preliminary data on the efficacy of armodafinil for improving menopause-related fatigue and quality of life.Methods:

Women (aged 40-65 y) experiencing menopause-related fatigue received open-label armodafinil therapy (up to 150 mg/d) for 4 weeks. Changes from baseline in Brief Fatigue Inventory score and Menopause-Specific Quality of Life (MENQOL) physical domain score were examined using the Wilcoxon signed rank test. Exploratory analyses examined the effects of armodafinil on hot flashes, overall quality of life, insomnia, depression, anxiety, and perceived cognitive performance. After open-label treatment, participants were randomized to double-blind continuation of armodafinil versus placebo for 2 weeks to examine whether treatment discontinuation would precipitate symptom recurrence.
Results:

Of 29 eligible participants, 20 women (69.0%) completed the trial. During treatment with armodafinil (mean dose, 120 mg/d), median Brief Fatigue Inventory scores decreased by 57.7% from 5.2 (interquartile range [IQR], 4.6-6.2) to 2.2 (IQR, 1.1-4.4; P = 0.0002), and median MENQOL physical domain scores decreased by 51.3% from 3.9 (IQR, 2.3-4.8) to 1.9 (IQR, 1.3-2.7; P = 0.0001). Median hot flashes for 24 hours decreased by 48.3% from 2.9 (IQR, 1.1-4.6) to 1.5 (IQR, 0.4-2.4; P = 0.0005). Improvements in MENQOL total score (49%; P = 0.0001), cognitive function (59.2%; P = 0.0002), depressive symptoms (64.7%; P = 0.0006), insomnia (72.7%; P = 0.0012), and excessive sleepiness (57.1%; P = 0.0006) were noted. Randomized continuation (n = 10) or discontinuation (n = 10) did not indicate group differences. Armodafinil was well-tolerated; three women (12%) were withdrawn for adverse events.
Conclusions:

These preliminary results suggest a therapeutic effect of armodafinil on fatigue affecting quality of life during menopause, and a potential benefit for other menopause-related symptoms.
No Reference information available - sign in for access.
No Citation information available - sign in for access.
No Supplementary Data.
No Article Media
No Metrics

Keywords: Armodafinil; Fatigue; Hot flashes; Menopause; Modafinil; Quality of life

Document Type: Research Article

Affiliations: 1: Department of Psychiatry, Brigham and Women's Hospital, Boston, MA, Department of Psycho-Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA 2: Department of Psychiatry, Massachusetts General Hospital, Boston, MA. 3: Department of Psychiatry, Brigham and Women's Hospital, Boston, MA 4: Department of Psychiatry, Brigham and Women's Hospital, Boston, MA, Department of Psycho-Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, Department of Psychiatry, Massachusetts General Hospital, Boston, MA.

Publication date: February 1, 2016

  • Access Key
  • Free content
  • Partial Free content
  • New content
  • Open access content
  • Partial Open access content
  • Subscribed content
  • Partial Subscribed content
  • Free trial content
Cookie Policy
X
Cookie Policy
Ingenta Connect website makes use of cookies so as to keep track of data that you have filled in. I am Happy with this Find out more