A Controlled Trial of Mifepristone in Gulf War Veterans W... | NCT00691067

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

NCT00691067

Sponsor

Bronx Veterans Medical Research Foundation, Inc

Status

Completed

Last Update Posted

Jan 31, 2017Estimated

Enrollment

65Actual

Phase

Phase 4

Conditions

Chronic Multisymptom Illness in Gulf War Veterans

Interventions

mifepristone
Placebos

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Jun 3, 2008

First Submission Date that Met QC Criteria

Jun 4, 2008

First Posted Date

Jun 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2017

Last Update Posted Date

Jan 31, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Julia Golier, Clinical Director, Mental Health Patient Care Center, Bronx Veterans Medical Research Foundation, IncPrincipal Investigator

Lead Sponsor

Bronx Veterans Medical Research Foundation, IncOTHER

Collaborators

Name	Class
U.S. Army Medical Research and Development Command	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mifepristone	Experimental	600mg of Mifepristone	Drug: mifepristone
Placebos	Placebo Comparator	Placebo	Drug: Placebos

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mifepristone	Drug	200 mg po per day x 6 weeks	Mifepristone
Placebos

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in the health components score of the veterans RAND 36-item health survey (VR-36)		baseline, every two weeks, endpoint

Secondary Outcomes

Measure	Description	Time Frame
cognitive functioning and measures of depression, fatigue and PTSD		baseline and endpoint

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julia A Golier, M.D.	James J Peters VA Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
James J Peters VA Medical Center		The Bronx	New York	10468	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26600007	Derived	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.

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds