Anxiety DisordersNCT00062517
Generalized Anxiety Disorder and Social Anxiety Disorder: Their Impact on the Processing of Information and Learning
An observational study of Anxiety Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The purpose of this study is to increase researchers understanding of the biological basis of generalized anxiety disorder and social anxiety disorder. They will investigate how the brain activity associated with specific thoughts and feelings may play a role in these anxiety disorders. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- How many people
- 497 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2003to 21 Sep 2016
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: Participants will be males and females, 18-50 years of age.
- IQ: IQ, as measured by 4 subscales from the Wechsler Adult Intelligence Scale-Revised (WAIS-R), must be > 80.
- Medication status: No regular use of psychotropic medication within 2 weeks of the study (or fluoxetine within 8 weeks of the study). No regular use of any benzodiazepine. We intend to identify patients whose GAD/SAD is currently untreated.
Who cannot join
- Because factors such as psychiatric disease, or CNS disease, can influence functional brain activity, and pregnancy precludes participation in fMRI studies, these factors are exclusionary.
- Psychiatric history: Participants will be assessed using DSM-IV criteria via standardized psychiatric interviews conducted by trained examiners (i.e., SCID). Any current suicidal ideation will be exclusionary.
- Healthy comparison individuals (Group 1): All participants will be free of any current psychiatric disorder as well as lifetime history of psychosis, pervasive developmental disorder, major affective disorder, panic disorder, obsessive compulsive disorder, conduct disorder, ADHD, anorexia.
- Patients with GAD (Group 2): Any history of an axis I diagnosis excluding SAD but not including adjustment disorder, simple phobia or dysthymia is exclusionary. There must be no current mood disoder (MD) though patients with past MD, which occurred after the onset of GAD, will be admitted to the study. We recognize the difficulty of recruiting patients with GAD without co-morbid SAD and will therefore allow patients who are comorbid into the study in this group. We have faced difficulties with our studies of children with psychopathic tendencies where, although it is possible to identify populations who only meet criteria for ADHD most children who meet criteria for psychopathic tendencies are co-morbid for ADHD. We will adopt a similar strategy to our work with children; i.e., in contrasts of patients with GAD with comparison individuals, we will use SAD symptomatology as a covariate to reduce, and evaluate, the impact of pathology associated with SAD on the data.
- Patients with SAD (Group 3): Any current history of an axis I diagnosis including GAD, but excluding adjustment disorder, simple phobia or dysthymia is exclusionary. There must be no current mood disorder (MD) though patients with past MD, which occurred after the onset of SAD, will be admitted to the study.
- History of Drug Abuse: Axis I diagnoses of substance use disorders will be exclusionary.
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- Severe acute and chronic medical illnesses.
- CNS disease: History of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), or other neurological disease, or history of head trauma (defined as loss of consciousness > 3 min).
- Metal or electronic objects: Metal plates, certain types of dental braces, cardiac pacemakers, etc., that are sensitive to electromagnetic fields contraindicate MRI scans.
- Claustrophobia: Participants will be questioned about potential discomfort in being in an enclosed space, such as an MRI scanner.
- Pregnancy status: Because of the potential effects of hormonal changes on brain function as well as the unknown effects of electromagnetic field on the fetus, known pregnancy is an exclusion criterion.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Generalized Anxiety Disorder and Social Anxiety Disorder: Their Impact on the Processing of Social Emotional Information and Instrumental Learning
The purpose of this study is to increase researchers understanding of the biological basis of generalized anxiety disorder and social anxiety disorder. They will investigate how the brain activity associated with specific thoughts and feelings may play a role in these anxiety disorders. This knowledge will be used to design interventions to help those with these illnesses.
To qualify for this study, participants must be evaluated via an initial telephone screening interview and material sent through the mail.
Read more
Participants will then be required to make three visits to NIH. During the first visit, they will be asked questions about their general mood, degree of nervousness, thinking skills, and behavior. They will undergo a thorough physical exam, including an EKG, blood work, urinalysis, and a pregnancy test for women of childbearing potential. During the second visit, participants will spend about 2.5 hours doing various tasks while sitting and looking at a computer screen. These tasks will guide them to experience specific kinds of thoughts and emotions. Researchers will attach electrodes to the participants hands to monitor the amount of electricity conducted by the skin. The third visit will be similar to the second visit, but participants will perform the tasks while lying in a MRI scanner.
Participants will be compensated up to $400 for their involvement in this study.
Read the detailed description
There have been suggestions that the threshold for amygdala activity is lower in individuals with anxiety disorders than in healthy individuals. However, despite it's immediate plausibility, there have been relatively few tests of this hypothesis. Specifically, there have been very few explorations of the performance of patients with anxiety disorders on measures known to implicate the amygdala.
Although the high co-morbidity of Generalized Anxiety Disorder (GAD) and Social Anxiety Disorder (SAD) complicates the issue, the fact that the disorders doubly dissociate suggests that they are due to dysfunctional activity in separable neurocognitive systems. We would suggest that the hyper-responsive amygdala hypothesis is more likely to be linked to the explanation of GAD. In contrast, SAD may be due to reduced activation thresholds for units in a system that responds to social threat and which recruits lateral orbital frontal cortex. Thus, the current project will determine the performance of patients with GAD and SAD on measures in which the amygdala is known to play a role and also measures that recruit lateral orbital frontal cortex and the system for social response reversal. In addition, two proposed neuro-imaging studies will directly assess neural responses in these two systems in both patient populations. The project should provide clear data that will constrain future theorizing on the pathology implicated in these two disorders.
- Conditions
- Anxiety Disorders
- Keywords
- Amygdala, Generalized Anxiety Disorder, Anxiety Disorder, GAD, Social Anxiety Disorder, SAD
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder, Phobia, Social
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of GAD/SAD with amygdala act
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2003 (estimated)
- Study start5 Jun 2003
- Study completion21 Sep 2016
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 Anxiety DisordersStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Karina S Peschardt, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062517
- Sponsor's protocol ID
- 030185
- Other IDs
- 03-M-0185
- Status last verified
- 21 Sep 2016
- First submitted
- 6 Jun 2003
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Adolphs R, Tranel D, Hamann S, Young AW, Calder AJ, Phelps EA, Anderson A, Lee GP, Damasio AR. Recognition of facial emotion in nine individuals with bilateral amygdala damage. Neuropsychologia. 1999 Sep;37(10):1111-7. doi: 10.1016/s0028-3932(99)00039-1.
PubMed 10509833Ambrogi Lorenzini CG, Baldi E, Bucherelli C, Sacchetti B, Tassoni G. Neural topography and chronology of memory consolidation: a review of functional inactivation findings. Neurobiol Learn Mem. 1999 Jan;71(1):1-18. doi: 10.1006/nlme.1998.3865.
PubMed 9889069Bechara A, Damasio H, Damasio AR, Lee GP. Different contributions of the human amygdala and ventromedial prefrontal cortex to decision-making. J Neurosci. 1999 Jul 1;19(13):5473-81. doi: 10.1523/JNEUROSCI.19-13-05473.1999.
PubMed 10377356
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generalized Anxiety Disorder and Social Anxiety Disorder: Their Impact on the Processing of Social Emotional Information and Instrumental Learning
- ClinicalTrials.gov ID
- NCT00062517
- Acronym / sponsor ID
- 030185
- Conditions
- Anxiety Disorders
- Keywords
- Amygdala, Generalized Anxiety Disorder, Anxiety Disorder, GAD, Social Anxiety Disorder, SAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 5 Jun 2003
- Study completion
- 21 Sep 2016
- First posted
- 9 Jun 2003 (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 purpose of this study is to increase researchers understanding of the biological basis of generalized anxiety disorder and social anxiety disorder. They will investigate how the brain activity associated with specific thoughts and feelings may play a role in these anxiety disorders. This knowledge will be used to design interventions to help those with these illnesses.
To qualify for this study, participants must be evaluated via an initial telephone screening interview and material sent through the mail.
Participants will then be required to make three visits to NIH. During the first visit, they will be asked questions about their general mood, degree of nervousness, thinking skills, and behavior. They will undergo a thorough physical exam, including an EKG, blood work, urinalysis, and a pregnancy test for women of childbearing potential. During the second visit, participants will spend about 2.5 hours doing various tasks while sitting and looking at a computer screen. These tasks will guide them to experience specific kinds of thoughts and emotions. Researchers will attach electrodes to the participants hands to monitor the amount of electricity conducted by the skin. The third visit will be similar to the second visit, but participants will perform the tasks while lying in a MRI scanner.
Participants will be compensated up to $400 for their involvement in this study.
Detailed description
There have been suggestions that the threshold for amygdala activity is lower in individuals with anxiety disorders than in healthy individuals. However, despite it's immediate plausibility, there have been relatively few tests of this hypothesis. Specifically, there have been very few explorations of the performance of patients with anxiety disorders on measures known to implicate the amygdala.
Although the high co-morbidity of Generalized Anxiety Disorder (GAD) and Social Anxiety Disorder (SAD) complicates the issue, the fact that the disorders doubly dissociate suggests that they are due to dysfunctional activity in separable neurocognitive systems. We would suggest that the hyper-responsive amygdala hypothesis is more likely to be linked to the explanation of GAD. In contrast, SAD may be due to reduced activation thresholds for units in a system that responds to social threat and which recruits lateral orbital frontal cortex. Thus, the current project will determine the performance of patients with GAD and SAD on measures in which the amygdala is known to play a role and also measures that recruit lateral orbital frontal cortex and the system for social response reversal. In addition, two proposed neuro-imaging studies will directly assess neural responses in these two systems in both patient populations. The project should provide clear data that will constrain future theorizing on the pathology implicated in these two disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: Participants will be males and females, 18-50 years of age.
- IQ: IQ, as measured by 4 subscales from the Wechsler Adult Intelligence Scale-Revised (WAIS-R), must be > 80.
- Medication status: No regular use of psychotropic medication within 2 weeks of the study (or fluoxetine within 8 weeks of the study). No regular use of any benzodiazepine. We intend to identify patients whose GAD/SAD is currently untreated.
Key exclusion criteria (11 listed)
- Because factors such as psychiatric disease, or CNS disease, can influence functional brain activity, and pregnancy precludes participation in fMRI studies, these factors are exclusionary.
- Psychiatric history: Participants will be assessed using DSM-IV criteria via standardized psychiatric interviews conducted by trained examiners (i.e., SCID). Any current suicidal ideation will be exclusionary.
- History of Drug Abuse: Axis I diagnoses of substance use disorders will be exclusionary.
- Severe acute and chronic medical illnesses.
- CNS disease: History of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), or other neurological disease, or history of head trauma (defined as loss of consciousness > 3 min).
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
Association of GAD/SAD with amygdala act
Time frame: Ongoing
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 6 Oct 2017.
- Background: PubMed 10509833Adolphs R, Tranel D, Hamann S, Young AW, Calder AJ, Phelps EA, Anderson A, Lee GP, Damasio AR. Recognition of facial emotion in nine individuals with bilateral amygdala damage. Neuropsychologia. 1999 Sep;37(10):1111-7. doi: 10.1016/s0028-3932(99)00039-1.
- Background: PubMed 9889069Ambrogi Lorenzini CG, Baldi E, Bucherelli C, Sacchetti B, Tassoni G. Neural topography and chronology of memory consolidation: a review of functional inactivation findings. Neurobiol Learn Mem. 1999 Jan;71(1):1-18. doi: 10.1006/nlme.1998.3865.
- Background: PubMed 10377356Bechara A, Damasio H, Damasio AR, Lee GP. Different contributions of the human amygdala and ventromedial prefrontal cortex to decision-making. J Neurosci. 1999 Jul 1;19(13):5473-81. doi: 10.1523/JNEUROSCI.19-13-05473.1999.
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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.
Karina S Peschardt, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
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 Disorders, 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 3 inclusion and 11 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 6 Oct 2017. 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.
What does the primary outcome measure?
Association of GAD/SAD with amygdala act (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00062517, 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 6 Oct 2017.