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

NCT00691067 | Completed Phase 4 DMC

• 1 other identifier: GW060048
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Multisymptom Illness in Gulf War Veterans

Outcome Measures

Primary Outcomes (1)

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

  baseline, every two weeks, endpoint

Secondary Outcomes (1)

• cognitive functioning and measures of depression, fatigue and PTSD

  baseline and endpoint

Study Arms (2)

Mifepristone

EXPERIMENTAL

600mg of Mifepristone

Drug: mifepristone

Placebos

PLACEBO COMPARATOR

Placebo

Drug: Placebos

Interventions

mifepristone DRUG

200 mg po per day x 6 weeks

Mifepristone

Placebos DRUG

placebo

Placebos

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bronx Veterans Medical Research Foundation, Inc: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

James J Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

Related Publications (1)

• 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.

  PMID: 26600007 DERIVED

MeSH Terms

Interventions

Mifepristone

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Julia A Golier, M.D.

  James J Peters VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director, Mental Health Patient Care Center

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 5, 2008
• Study Start: May 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

US (1)