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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00062517 |
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.
Condition |
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Anxiety Disorders |
Study Type: | Observational |
Official Title: | Generalized Anxiety Disorder and Social Anxiety Disorder: Their Impact on the Processing of Social Emotional Information and Instrumental Learning |
Estimated Enrollment: | 300 |
Study Start Date: | June 2003 |
There have been suggestions that the threshold for amygdala activity is lower in individuals with anxiety disorders than in healthy individuals. However, despite its 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 ib 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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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 greater than 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.
EXCLUSION CRITERIA:
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.
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 030185, 03-M-0185 |
Study First Received: | June 6, 2003 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00062517 |
Health Authority: | United States: Federal Government |
Amygdala Orbital Frontal Cortex Emotion fMRI Neurocognitive Generalized Anxiety Disorder Social Phobia Orbitofrontal Cortex |
Facial Affect Instrumental Learning Anxiety Disorder Generalized Anxiety Disorder GAD Social Anxiety Disorder SAD |
Anxiety Disorders Facies Mental Disorders Phobic Disorders |
Pathologic Processes Disease |