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OpenTrials
Completed

NCT Number: NCT00691067

A Controlled 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.

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Key information

Conditions

Chronic Multisymptom Illness in Gulf War Veterans

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

James J Peters VA Medical Center

The Bronx, New York, 10468, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mifepristone

Drug

200 mg po per day x 6 weeks

Placebos

Drug

placebo

Primary outcomes

  1. change in the health components score of the veterans RAND 36-item health survey (VR-36)

    Time frame: baseline, every two weeks, endpoint

Secondary outcomes

  1. cognitive functioning and measures of depression, fatigue and PTSD

    Time frame: baseline and endpoint

Sponsors and collaborators

Lead sponsor

Bronx Veterans Medical Research Foundation, Inc

Other

Collaborators

  • U.S. Army Medical Research and Development Command

Registry information

Official study title

A Randomized, Double-blind Placebo-controlled Crossover Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jun 5, 2008
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.