NCT01460628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

March 15, 2017

Completed
Last Updated

March 15, 2017

Status Verified

January 1, 2017

Enrollment Period

1.6 years

First QC Date

October 25, 2011

Results QC Date

July 12, 2016

Last Update Submit

January 25, 2017

Conditions

Menopause

Keywords

fatiguemenopausal symptomshot flashesVasomotor symptomsperimenopauserelated Quality of life

Outcome Measures

Primary Outcomes (2)

  • Menopause Quality Of Life Questionnaire (MENQOL) Physical Domain Subscale

    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.

    4 weeks

  • Brief Fatigue Inventory (BFI)

    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. .

    4 weeks

Secondary Outcomes (5)

  • Epsworth Sleepiness Scale (ESS)

    4 weeks

  • Hot Flash Frequency (24-hr Period)

    4 weeks

  • Symptom Checklist-10 Anxiety

    4 weeks

  • Patient Health Questionnaire-9 (PHQ-9)

    4 weeks

  • Brown Attention Deficit Disorder Scale (BADDS)

    4 weeks

Study Arms (1)

Armodafinil

EXPERIMENTAL

Armodafinil is the drug being tested.

Drug: Armodafinil

Interventions

ArmodafinilDRUG

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. For exploratory reasons only, 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. No primary outcomes were studied in the discontinuation phase.

Also known as: Nuvigil
Armodafinil

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women
  • Ages 40-65
  • Peri- and postmenopausal
  • Suffering from fatigue
  • Experiencing hot flashes(Not required for perimenopausal women)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

FatigueHot Flashes

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr. Hadine Joffe
Organization
Brigham & Women's Hospital
hjoffe@partners.org
617-732-4906

Study Officials

  • Hadine Joffe, MD, MSc

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chair for Research, Psychiatry Department

Study Record Dates

First Submitted

October 25, 2011

First Posted

October 27, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2013

Study Completion

December 1, 2013

Last Updated

March 15, 2017

Results First Posted

March 15, 2017

Record last verified: 2017-01

Locations

US(1)