Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT00691067
Status:
COMPLETED
Last Update Posted:
2017-01-31
First Post:
2008-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Controlled Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015735', 'term': 'Mifepristone'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2008-06-03', 'studyFirstSubmitQcDate': '2008-06-04', 'lastUpdatePostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in the health components score of the veterans RAND 36-item health survey (VR-36)', 'timeFrame': 'baseline, every two weeks, endpoint'}], 'secondaryOutcomes': [{'measure': 'cognitive functioning and measures of depression, fatigue and PTSD', 'timeFrame': 'baseline and endpoint'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Multisymptom Illness in Gulf War Veterans']}, 'referencesModule': {'references': [{'pmid': '26600007', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veteran of the 1991 Gulf War\n* Veteran meets criteria for multisymptom illness\n\nExclusion Criteria:\n\n* Veteran lacks the capacity to provide consent.\n* Veteran has a major medical or neurological disorder or traumatic brain injury\n* Veteran has morning plasma cortisol level less than 5 mcg/dl or a history of adrenal insufficiency\n* Veteran is taking oral corticosteroids\n* Veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder\n* Veteran has been psychiatrically hospitalized or attempted suicide within the previous 2 years\n* Veteran has current suicidal ideation\n* 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.\n* Women veterans with diseases of the uterus by history or a family history of uterine cancer\n* Known allergy to mifepristone'}, 'identificationModule': {'nctId': 'NCT00691067', 'briefTitle': 'A Controlled Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness', 'organization': {'class': 'OTHER', 'fullName': 'Bronx Veterans Medical Research Foundation, Inc'}, 'officialTitle': 'A Randomized, Double-blind Placebo-controlled Crossover Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness', 'orgStudyIdInfo': {'id': 'GW060048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mifepristone', 'description': '600mg of Mifepristone', 'interventionNames': ['Drug: mifepristone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebos', 'description': 'Placebo', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'mifepristone', 'type': 'DRUG', 'description': '200 mg po per day x 6 weeks', 'armGroupLabels': ['Mifepristone']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['Placebos']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10468', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'James J Peters VA Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Julia A Golier, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'James J Peters VA Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bronx Veterans Medical Research Foundation, Inc', 'class': 'OTHER'}, 'collaborators': [{'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Director, Mental Health Patient Care Center', 'investigatorFullName': 'Julia Golier', 'investigatorAffiliation': 'Bronx Veterans Medical Research Foundation, Inc'}}}}