- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
<TAB>
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Maryland
-
Bethesda, Maryland, 미국, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .