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Trial record 1 of 1 for:    mifepristone gulf war
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A Controlled Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness

This study has been completed.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Julia Golier, Bronx Veterans Medical Research Foundation, Inc
ClinicalTrials.gov Identifier:
NCT00691067
First received: June 3, 2008
Last updated: January 30, 2017
Last verified: January 2017
June 3, 2008
January 30, 2017
May 2008
August 2012   (Final data collection date for primary outcome measure)
change in the health components score of the veterans RAND 36-item health survey (VR-36) [ Time Frame: baseline, every two weeks, endpoint ]
Same as current
Complete list of historical versions of study NCT00691067 on ClinicalTrials.gov Archive Site
cognitive functioning and measures of depression, fatigue and PTSD [ Time Frame: baseline and endpoint ]
Same as current
Not Provided
Not Provided
 
A Controlled Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness
A Randomized, Double-blind Placebo-controlled Crossover Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness
We propose to conduct placebo-controlled trial of the glucocorticoid receptor antagonist mifepristone in Gulf War veterans (GWV) with chronic multisymptom illness (CMI) to examine its effects on physical and mental health and cognitive functioning. In addition, we propose to examine whether HPA axis biomarkers or their response to mifepristone are useful predictors of clinical response.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Multisymptom Illness in Gulf War Veterans
  • Drug: mifepristone
    200 mg po per day x 6 weeks
  • Drug: Placebos
    placebo
  • Experimental: Mifepristone
    600mg of Mifepristone
    Intervention: Drug: mifepristone
  • Placebo Comparator: Placebos
    Placebo
    Intervention: Drug: Placebos
Golier JA, Caramanica K, Michaelides AC, Makotkine I, Schmeidler J, Harvey PD, Yehuda R. A randomized, double-blind, placebo-controlled, crossover trial of mifepristone in Gulf War veterans with chronic multisymptom illness. Psychoneuroendocrinology. 2016 Feb;64:22-30. doi: 10.1016/j.psyneuen.2015.11.001. Epub 2015 Nov 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
August 2012
August 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Veteran of the 1991 Gulf War
  • Veteran meets criteria for multisymptom illness

Exclusion Criteria:

  • Veteran lacks the capacity to provide consent.
  • Veteran has a major medical or neurological disorder or traumatic brain injury
  • Veteran has morning plasma cortisol level less than 5 mcg/dl or a history of adrenal insufficiency
  • Veteran is taking oral corticosteroids
  • Veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder
  • Veteran has been psychiatrically hospitalized or attempted suicide within the previous 2 years
  • Veteran has current suicidal ideation
  • Veteran is pregnant or breastfeeding or plans to become pregnant within the year (male or female) not willing to use appropriate forms of contraception during the study and for at least 90 days post treatment.
  • Women veterans with diseases of the uterus by history or a family history of uterine cancer
  • Known allergy to mifepristone
Sexes Eligible for Study: All
35 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00691067
GW060048
Yes
Not Provided
Not Provided
Julia Golier, Bronx Veterans Medical Research Foundation, Inc
Bronx Veterans Medical Research Foundation, Inc
U.S. Army Medical Research and Materiel Command
Principal Investigator: Julia A Golier, M.D. James J Peters VA Medical Center
Bronx Veterans Medical Research Foundation, Inc
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP