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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00691067
First Posted: June 5, 2008
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Julia Golier, Bronx Veterans Medical Research Foundation, Inc
  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: Placebos Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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:


Further study details as provided by Julia Golier, 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 ]

Secondary Outcome Measures:
  • cognitive functioning and measures of depression, fatigue and PTSD [ Time Frame: baseline and endpoint ]

Enrollment: 65
Study Start Date: May 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mifepristone
600mg of Mifepristone
Drug: mifepristone
200 mg po per day x 6 weeks
Placebo Comparator: Placebos
Placebo
Drug: Placebos
placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691067


Locations
United States, New York
James J Peters VA Medical Center
Bronx, New York, United States, 10468
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: June 3, 2008
First Posted: June 5, 2008
Last Update Posted: January 31, 2017
Last Verified: January 2017

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