AnxietyNCT00101777
Ventilatory Physiology in Children at Risk for Anxiety
An observational study of Anxiety and Panic Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The importance of the proposed research project derives from a steady accumulation of research findings on the relationship between respiration and anxiety. The relationship between panic disorder and abnormalities in respiration has been recognized for more than 10 years. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Panic Disorder
- How many people
- 479 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Nov 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Ages greater than or equal to 9 years 0 months.
- Parent able to give written informed consent.
- Offspring ages 12 years 0 months to 17 years 11 months able to give written assent.
- Offspring ages 9 years 0 months to 11 years 11 months able to give verbal assent.
- Offspring ages 18 years 0 months.
- Absence of medical condition that will interfere with CO(2) procedure.
Show all 11Show fewer
- Has met DSM-IV criteria for one or more of the following disorders:
- Panic Disorder
- Social Phobia
- Major Depressive Disorder
- OR No Disorder.
Who cannot join
- Clinically significant or unstable medical disorders; cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, hematological or other systemic disease.
- History of mania, schizophrenia or other psychosis, or current serious suicidal ideation.
- Females who are pregnant.
- Children currently on medications that affect breathing.
- IQ less than 70.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
The importance of the proposed research project derives from a steady accumulation of research findings on the relationship between respiration and anxiety. The relationship between panic disorder and abnormalities in respiration has been recognized for more than 10 years. Increased sensitivity to CO2 exposure in panic disorder represents the most consistent finding supporting this relationship. The current proposal follows naturally from three sets of recent research findings in the area of panic disorder. First, our group has recently shown that children with anxiety disorders, like adults with panic disorder, exhibit increased sensitivity to CO2. Second, other researchers have shown that psychiatrically healthy relatives of patients with panic disorder also exhibit increased sensitvity to CO2. Finally, our group has also recently shown that children of adults with panic disorder exhibit high rates of anxiety disorders, particularly separation anxiety disorder, the childhood anxiety disorder which exhibits the highest degree of CO2 sensitivity. These three findings suggest that children of parents with panic disorder may exhibit a latent vulnerability to panic disorder, manifested as increased sensitivity to CO2.
A secondary feature of the proposed research project derives from a steady accumulation of research findings in basic science literature outlining the parts of the brain that mediate fear and anxiety in animals. It may be possible to use insights from research on the brain basis of fear in animals to develop methods for assessing the brain basis of fear in humans. Moreover, work in animals notes changes in brain systems that mediate fear and anxiety across development. If development. If developmentally sensitive methods could be used to study fear in children, it may also be possible to greatly enhance our understanding of the manner in which the relationship between brain function and fear changes as children age. If similarities could be demonstrated across animals and humans in these areas, new insights on potential treatments for anxiety could be more readily transferred from the laboratory to the clinic. A second goal of the current proposal is to refine two neuropsychological probes that are thought to assess functional aspects of brain systems implicated in fear and anxiety across various species, from rodents to humans.
Read the detailed description
The importance of the proposed research project derives from a steady accumulation of research findings on the relationship between respiration and anxiety. The relationship between panic disorder and abnormalities in respiration has been recognized for more than 10 years. Increased sensitivity to CO2 exposure in panic disorder represents the most consistent finding supporting this relationship. The current proposal follows naturally from three sets of recent research findings in the area of panic disorder. First, our group has recently shown that children with anxiety disorders, like adults with panic disorder, exhibit increased sensitivity to CO2. Second, other researchers have shown that psychiatrically healthy relatives of patients with panic disorder also exhibit increased sensitvity to CO2. Finally, our group has also recently shown that children of adults with panic disorder exhibit high rates of anxiety disorders, particularly separation anxiety disorder, the childhood anxiety disorder which exhibits the highest degree of CO2 sensitivity. These three findings suggest that children of parents with panic disorder may exhibit a latent vulnerability to panic disorder, manifested as increased sensitivity to CO2.
A secondary feature of the proposed research project derives from a steady accumulation of research findings in basic science literature outlining the parts of the brain that mediate fear and anxiety in animals. It may be possible to use insights from research on the brain basis of fear in animals to develop methods for assessing the brain basis of fear in humans. Moreover, work in animals notes changes in brain systems that mediate fear and anxiety across development. If developmentally sensitive methods could be used to study fear in children, it may also be possible to greatly enhance our understanding of the manner in which the relationship between brain function and fear changes as children age. If similarities could be demonstrated across animals and humans in these areas, new insights on potential treatments for anxiety could be more readily transferred from the laboratory to the clinic. A second goal of the current proposal is to refine two neuropsychological probes that are thought to assess functional aspects of brain systems implicated in fear and anxiety across various species, from rodents to humans.
- Conditions
- Anxiety, Panic Disorder
- Keywords
- Anxiety, Ventilation, Panic Disorder, Children, Healthy Volunteer, HV, Normal Control
- Medical subject headings
- Anxiety Disorders, Panic Disorder, Respiratory Aspiration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2005 (estimated)
- Study startDec 2001
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 479 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00101777
- Sponsor's protocol ID
- 020093
- Other IDs
- 02-M-0093
- Status last verified
- Nov 2005
- First submitted
- 12 Jan 2005
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Papp LA, Klein DF, Martinez J, Schneier F, Cole R, Liebowitz MR, Hollander E, Fyer AJ, Jordan F, Gorman JM. Diagnostic and substance specificity of carbon-dioxide-induced panic. Am J Psychiatry. 1993 Feb;150(2):250-7. doi: 10.1176/ajp.150.2.250.
PubMed 8123056Papp LA, Martinez JM, Klein DF, Coplan JD, Norman RG, Cole R, de Jesus MJ, Ross D, Goetz R, Gorman JM. Respiratory psychophysiology of panic disorder: three respiratory challenges in 98 subjects. Am J Psychiatry. 1997 Nov;154(11):1557-65. doi: 10.1176/ajp.154.11.1557.
PubMed 9356564Perna G, Gabriele A, Caldirola D, Bellodi L. Hypersensitivity to inhalation of carbon dioxide and panic attacks. Psychiatry Res. 1995 Aug 28;57(3):267-73. doi: 10.1016/0165-1781(95)02723-a.
PubMed 7501737
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilatory Physiology in Children at Risk for Anxiety
- ClinicalTrials.gov ID
- NCT00101777
- Acronym / sponsor ID
- 020093
- Conditions
- Anxiety, Panic Disorder
- Keywords
- Anxiety, Ventilation, Panic Disorder, Children, Healthy Volunteer, HV, Normal Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 479 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Dec 2001
- Study completion
- Nov 2005
- First posted
- 13 Jan 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The importance of the proposed research project derives from a steady accumulation of research findings on the relationship between respiration and anxiety. The relationship between panic disorder and abnormalities in respiration has been recognized for more than 10 years. Increased sensitivity to CO2 exposure in panic disorder represents the most consistent finding supporting this relationship. The current proposal follows naturally from three sets of recent research findings in the area of panic disorder. First, our group has recently shown that children with anxiety disorders, like adults with panic disorder, exhibit increased sensitivity to CO2. Second, other researchers have shown that psychiatrically healthy relatives of patients with panic disorder also exhibit increased sensitvity to CO2. Finally, our group has also recently shown that children of adults with panic disorder exhibit high rates of anxiety disorders, particularly separation anxiety disorder, the childhood anxiety disorder which exhibits the highest degree of CO2 sensitivity. These three findings suggest that children of parents with panic disorder may exhibit a latent vulnerability to panic disorder, manifested as increased sensitivity to CO2.
A secondary feature of the proposed research project derives from a steady accumulation of research findings in basic science literature outlining the parts of the brain that mediate fear and anxiety in animals. It may be possible to use insights from research on the brain basis of fear in animals to develop methods for assessing the brain basis of fear in humans. Moreover, work in animals notes changes in brain systems that mediate fear and anxiety across development. If development. If developmentally sensitive methods could be used to study fear in children, it may also be possible to greatly enhance our understanding of the manner in which the relationship between brain function and fear changes as children age. If similarities could be demonstrated across animals and humans in these areas, new insights on potential treatments for anxiety could be more readily transferred from the laboratory to the clinic. A second goal of the current proposal is to refine two neuropsychological probes that are thought to assess functional aspects of brain systems implicated in fear and anxiety across various species, from rodents to humans.
Detailed description
The importance of the proposed research project derives from a steady accumulation of research findings on the relationship between respiration and anxiety. The relationship between panic disorder and abnormalities in respiration has been recognized for more than 10 years. Increased sensitivity to CO2 exposure in panic disorder represents the most consistent finding supporting this relationship. The current proposal follows naturally from three sets of recent research findings in the area of panic disorder. First, our group has recently shown that children with anxiety disorders, like adults with panic disorder, exhibit increased sensitivity to CO2. Second, other researchers have shown that psychiatrically healthy relatives of patients with panic disorder also exhibit increased sensitvity to CO2. Finally, our group has also recently shown that children of adults with panic disorder exhibit high rates of anxiety disorders, particularly separation anxiety disorder, the childhood anxiety disorder which exhibits the highest degree of CO2 sensitivity. These three findings suggest that children of parents with panic disorder may exhibit a latent vulnerability to panic disorder, manifested as increased sensitivity to CO2.
A secondary feature of the proposed research project derives from a steady accumulation of research findings in basic science literature outlining the parts of the brain that mediate fear and anxiety in animals. It may be possible to use insights from research on the brain basis of fear in animals to develop methods for assessing the brain basis of fear in humans. Moreover, work in animals notes changes in brain systems that mediate fear and anxiety across development. If developmentally sensitive methods could be used to study fear in children, it may also be possible to greatly enhance our understanding of the manner in which the relationship between brain function and fear changes as children age. If similarities could be demonstrated across animals and humans in these areas, new insights on potential treatments for anxiety could be more readily transferred from the laboratory to the clinic. A second goal of the current proposal is to refine two neuropsychological probes that are thought to assess functional aspects of brain systems implicated in fear and anxiety across various species, from rodents to humans.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Ages greater than or equal to 9 years 0 months.
- Parent able to give written informed consent.
- Offspring ages 12 years 0 months to 17 years 11 months able to give written assent.
- Offspring ages 9 years 0 months to 11 years 11 months able to give verbal assent.
- Offspring ages 18 years 0 months.
Key exclusion criteria (5 listed)
- Clinically significant or unstable medical disorders; cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, hematological or other systemic disease.
- History of mania, schizophrenia or other psychosis, or current serious suicidal ideation.
- Females who are pregnant.
- Children currently on medications that affect breathing.
- IQ less than 70.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8123056Papp LA, Klein DF, Martinez J, Schneier F, Cole R, Liebowitz MR, Hollander E, Fyer AJ, Jordan F, Gorman JM. Diagnostic and substance specificity of carbon-dioxide-induced panic. Am J Psychiatry. 1993 Feb;150(2):250-7. doi: 10.1176/ajp.150.2.250.
- Background: PubMed 9356564Papp LA, Martinez JM, Klein DF, Coplan JD, Norman RG, Cole R, de Jesus MJ, Ross D, Goetz R, Gorman JM. Respiratory psychophysiology of panic disorder: three respiratory challenges in 98 subjects. Am J Psychiatry. 1997 Nov;154(11):1557-65. doi: 10.1176/ajp.154.11.1557.
- Background: PubMed 7501737Perna G, Gabriele A, Caldirola D, Bellodi L. Hypersensitivity to inhalation of carbon dioxide and panic attacks. Psychiatry Res. 1995 Aug 28;57(3):267-73. doi: 10.1016/0165-1781(95)02723-a.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Panic Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00101777, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.