- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00930657
CO2 Inhalation and Risk for Panic Disorder
Objective:
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 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).
Study population:
Approximately 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.
Design:
A 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.
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Outcome measures:
Outcome 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.
Study Overview
Status
Conditions
Detailed Description
Objective:
The 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).
Study population:
Approximately 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.
Design:
Offspring(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.
Outcome measures:
Our 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
- Children age 9-18, and young adults 18-20 who have a parent with a past or current history of PD.
EXCLUSION CRITERIA (ALL PARTICIPANTS):
- 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,
- Subjects who are currently at high risk for homicide or suicide,
- Subjects with symptoms of psychosis
- Subjects with current DSM-IV substance abuse or dependence within the past year.
- Subjects with IQ<70,
ADDITIONAL EXCLUSION CRITERIA FOR CHILDREN:
- mania,
- pervasive developmental disorder,
- use of psychotropic medication,
- Child participants must be psychotropic free for at least 14 days prior to the CO(2) challenge session.
- For children taking fluoxetine, they must be free of this medication for at least 4 weeks.
- The proband parent must be a legal guardian of the child to qualify for the study.
Offspring 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.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 090177
- 09-M-0177
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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