CO2 Inhalation and Risk for Panic Disorder

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00930657
First received: June 27, 2009
Last updated: March 14, 2014
Last verified: September 2013
  Purpose

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.


Condition
Panic Disorder

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: CO2 Inhalation and Risk for Panic Disorder

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 13
Study Start Date: June 2009
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.

  Eligibility

Ages Eligible for Study:   9 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930657

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Daniel S Pine, M.D. National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00930657     History of Changes
Other Study ID Numbers: 090177, 09-M-0177
Study First Received: June 27, 2009
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Panic Disorder
Separation Anxiety
Familial
Risk
Respiratory Physiology

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014