CO2 Inhalation and Risk for Panic Disorder

Panic Disorder Clinical Trial

Official title:

CO2 Inhalation and Risk for Panic Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00930657
• Other study ID #: 090177
• Secondary ID: 09-M-0177
• Status: Terminated
• Start date: June 26, 2009
• Est. completion date: August 12, 2019

Study information

• Verified date: August 12, 2019
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: August 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 20 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Disease
• Panic Disorder

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Abrams K, Rassovsky Y, Kushner MG. Evidence for respiratory and nonrespiratory subtypes in panic disorder. Depress Anxiety. 2006;23(8):474-81. — View Citation

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. Epub 2007 Jan 24. — View Citation

Biber B, Alkin T. Panic disorder subtypes: differential responses to CO2 challenge. Am J Psychiatry. 1999 May;156(5):739-44. — View Citation