NCT00930657

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
10.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 12, 2019

First QC Date

June 27, 2009

Last Update Submit

August 13, 2019

Conditions

Panic Disorder

Keywords

Panic DisorderSeparation AnxietyFamilialRiskRespiratory Physiology

Eligibility Criteria

Age9 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children age 9-18, and young adults 18-20 who have a parent with a past or current history of PD.

You may not qualify if:

  • 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,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 16841338BACKGROUND

  • 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.

    PMID: 17254605BACKGROUND

  • 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.

    PMID: 10327907BACKGROUND

MeSH Terms

Conditions

Panic DisorderAnxiety, Separation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersNeurodevelopmental Disorders

Study Officials

  • Daniel S Pine, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2009

First Posted

June 30, 2009

Study Start

June 26, 2009

Study Completion

August 12, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08-12

Locations

US(1)