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CO2 Inhalation and Risk for Panic Disorder
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), June 2009
First Received: June 27, 2009   Last Updated: September 15, 2009   History of Changes
Sponsor: National Institute of Mental Health (NIMH)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00930657
  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.

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: 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):

Estimated Enrollment: 300
Study Start Date: June 2009
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

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.

  Eligibility

Ages Eligible for Study:   9 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • Adults with a history of PD who have eligible children (see exclusionary criteria for offspring below) between the ages of 9 and 20 years.

EXCLUSION CRITERIA:

  • 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 psychotic features, and subjects with current DSM-IV substance abuse or dependence within the past year.
  • The individual conducting the telephone screen also will ask the parent questions about their child(ren). Exclusionary criteria for children include: psychosis, mania, pervasive developmental disorder, use of psychotropic medication, an IQ less than 70, and acute medical conditions (e.g., asthma).
  • Child participants must be psychotropic free for at least 14 days prior to the CO2 challenge session.
  • For children taking fluoxetine, they must be free of this medication for at least 4 weeks.
  • We will not take any child participant off their medication to participate in this study.
  • The proband parent must be a legal guardian of the child to qualify for the study.
  • Families passing screening criteria will be scheduled for an intake to complete a clinical interview, questionnaires, and CO2 challenge task with assessment of respiratory physiology.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930657

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23284
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
Study ID Numbers: 090177, 09-M-0177
Study First Received: June 27, 2009
Last Updated: September 15, 2009
ClinicalTrials.gov Identifier: NCT00930657     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Panic Disorder
Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 05, 2009