- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 090177
- 09-M-0177
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Ensaios clínicos em Síndrome do pânico
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