Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-29 @ 2:30 AM
Study NCT ID:
NCT00930657
Status:
TERMINATED
Last Update Posted:
2019-08-14
First Post:
2009-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CO2 Inhalation and Risk for Panic Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016584', 'term': 'Panic Disorder'}, {'id': 'D001010', 'term': 'Anxiety, Separation'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-06-26'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08-12', 'completionDateStruct': {'date': '2019-08-12'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2009-06-27', 'studyFirstSubmitQcDate': '2009-06-27', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-30', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Panic Disorder', 'Separation Anxiety', 'Familial', 'Risk', 'Respiratory Physiology'], 'conditions': ['Panic Disorder']}, 'referencesModule': {'references': [{'pmid': '16841338', 'type': 'BACKGROUND', 'citation': 'Abrams K, Rassovsky Y, Kushner MG. Evidence for respiratory and nonrespiratory subtypes in panic disorder. Depress Anxiety. 2006;23(8):474-81. doi: 10.1002/da.20179.'}, {'pmid': '17254605', 'type': 'BACKGROUND', 'citation': 'Battaglia M, Ogliari A, Harris J, Spatola CA, Pesenti-Gritti P, Reichborn-Kjennerud T, Torgersen S, Kringlen E, Tambs K. A genetic study of the acute anxious response to carbon dioxide stimulation in man. J Psychiatr Res. 2007 Dec;41(11):906-17. doi: 10.1016/j.jpsychires.2006.12.002. Epub 2007 Jan 24.'}, {'pmid': '10327907', 'type': 'BACKGROUND', 'citation': 'Biber B, Alkin T. Panic disorder subtypes: differential responses to CO2 challenge. Am J Psychiatry. 1999 May;156(5):739-44. doi: 10.1176/ajp.156.5.739.'}]}, 'descriptionModule': {'briefSummary': 'Objective:\n\nTo examine respiratory/physiological and subjective responding as well as genetic transmission among offspring of parents with a history of or current panic disorder (PD) diagnosis to determine whether diagnoses/symptoms, endophenotypes, or genetic profiles in offspring is differentially related to parent PD subtypes (i.e., respiratory and non-respiratory panic).\n\nStudy population:\n\nApproximately 400 offspring of about 200 parents with current or past PD. Approximately 200 offsping/100 parents with PD will be enrolled at NIH/NIMH and the remainder at Virginia Commonwealth University in Richmond, VA.\n\nDesign:\n\nA high-risk family design will be used wherein parents with either a current or past diagnosis of PD who have an offspring(s) (ages 9 to 20) will be recruited.\n\n\\<TAB\\>\n\nOutcome measures:\n\nOutcome measures will include physiological recordings of respiratory, cardiac, and electrodermal responding during a 10 minute baseline followed by 15 minutes of 5% carbon dioxide enriched air (CO2). Research participants also will complete parent and child self-report measures and provide a DNA sample using a saliva protocol. A full listing of self-reports is provided in the Outcome Measures Section.', 'detailedDescription': 'Objective:\n\nThe objective of this study is to examine respiratory/physiological and subjective responding as well as genetic transmission among offspring of parents with a history of or current panic disorder (PD) diagnosis. Our goal is to determine whether diagnoses/symptoms, endophenotypes, or genetic profiles in offspring is differentially related to parent PD subtypes (i.e., respiratory and non-respiratory panic).\n\nStudy population:\n\nApproximately 80 offspring between the ages of 9 and 20 years of age who have a parent with a current or past history of PD will be recruited. Approximately 40 offspring will be enrolled at NIH/NIMH and the remainder at Virginia Commonwealth University in Richmond, VA.\n\nDesign:\n\nOffspring(s) between the ages of 9 to 20 who have a parent with a history of PD will be recruited. A complete psychiatric history will be obtained on all child participants. Child participants also will complete questionnaire measures, provide a sample of DNA, and participate in a carbon dioxide CO(2) lab challenge. The CO(2) lab challenge is the primary outcome measure.\n\nOutcome measures:\n\nOur primary outcome measures include physiological recordings of respiratory, cardiac, and electrodermal responding during a 10 minute baseline followed by 15 minutes of 5% carbon dioxide enriched air (CO(2). Research participants also will complete parent and child self-report measures and provide a DNA sample using a saliva protocol. A full listing of self-reports is provided in the Outcome Measures Section.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n* Children age 9-18, and young adults 18-20 who have a parent with a past or current history of PD.\n\nEXCLUSION CRITERIA (ALL PARTICIPANTS):\n\n* Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease, one or more past seizures without a clear and resolved etiology,\n* Subjects who are currently at high risk for homicide or suicide,\n* Subjects with symptoms of psychosis\n* Subjects with current DSM-IV substance abuse or dependence within the past year.\n* Subjects with IQ\\<70,\n\nADDITIONAL EXCLUSION CRITERIA FOR CHILDREN:\n\n* mania,\n* pervasive developmental disorder,\n* use of psychotropic medication,\n* Child participants must be psychotropic free for at least 14 days prior to the CO(2) challenge session.\n* For children taking fluoxetine, they must be free of this medication for at least 4 weeks.\n* The proband parent must be a legal guardian of the child to qualify for the study.\n\nOffspring passing screening criteria will be scheduled for an intake to complete a clinical interview, questionnaires, and CO(2) challenge task with assessment of respiratory physiology.'}, 'identificationModule': {'nctId': 'NCT00930657', 'briefTitle': 'CO2 Inhalation and Risk for Panic Disorder', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'CO2 Inhalation and Risk for Panic Disorder', 'orgStudyIdInfo': {'id': '090177'}, 'secondaryIdInfos': [{'id': '09-M-0177'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center, 9000 Rockville Pike', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Daniel S Pine, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Mental Health (NIMH)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}