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

June 27, 2009
September 15, 2009
June 2009
April 2011   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00930657 on ClinicalTrials.gov Archive Site
 
 
 
CO2 Inhalation and Risk for Panic Disorder
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.

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.

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.

 
Observational
Prospective
Panic Disorder
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
300
 
April 2011   (final data collection date for primary outcome measure)
  • 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.
Both
9 Years to 20 Years
Yes
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010
United States
 
NCT00930657
 
090177, 09-M-0177
National Institute of Mental Health (NIMH)
 
 
National Institutes of Health Clinical Center (CC)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP