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

This study is currently recruiting participants.
Verified September 2011 by Bronx Veterans Medical Research Foundation, Inc
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Multisymptom Illness in Gulf War Veterans
 Drug: mifepristone
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Placebo-controlled Crossover Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bronx Veterans Medical Research Foundation, Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • cognitive functioning and measures of depression, fatigue and PTSD [ Time Frame: baseline and endpoint ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2008
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: mifepristone
    200 mg po per day x 6 weeks
    Drug: placebo
    placebo
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691067

Contacts
Contact: Julia A Golier, M.D. 718-584-9000 ext 5196 julia.golier@va.gov

Locations
United States, New York
James J Peters VA Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Julia A Golier, M.D.     718-584-9000 ext 5196     julia.golier@va.gov    
Principal Investigator: Julia A Golier, M.D.            
Sponsors and Collaborators
Bronx Veterans Medical Research Foundation, Inc
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Julia A Golier, M.D. James J Peters VA Medical Center
  More Information

No publications provided

Responsible Party: Julia Golier, Clinical Director, Mental Health Patient Care Center, Bronx Veterans Medical Research Foundation, Inc
ClinicalTrials.gov Identifier: NCT00691067     History of Changes
Other Study ID Numbers: GW060048
Study First Received: June 3, 2008
Last Updated: September 9, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mifepristone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
 Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 16, 2013