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A Controlled Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Bronx Veterans Medical Research Foundation, Inc.
Recruitment status was  Recruiting
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: September 9, 2011
Last verified: September 2011

June 3, 2008
September 9, 2011
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Multisymptom Illness in Gulf War Veterans
  • Drug: mifepristone
    200 mg po per day x 6 weeks
  • Drug: placebo
    placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
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
Both
35 Years and older
No
Contact: Julia A Golier, M.D. 718-584-9000 ext 5196 julia.golier@va.gov
United States
 
NCT00691067
GW060048
Yes
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
September 2011

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