NCT00062517

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
497

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 5, 2003

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 6, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2003

Completed
13.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2016

Completed
Last Updated

October 6, 2017

Status Verified

September 21, 2016

First QC Date

June 6, 2003

Last Update Submit

October 5, 2017

Conditions

Anxiety Disorders

Keywords

AmygdalaGeneralized Anxiety DisorderAnxiety DisorderGADSocial Anxiety DisorderSAD

Outcome Measures

Primary Outcomes (1)

  • Association of GAD/SAD with amygdala act

    Ongoing

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

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)

  • 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.

    PMID: 10509833BACKGROUND

  • Ambrogi 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.

    PMID: 9889069BACKGROUND

  • Bechara 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.

    PMID: 10377356BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersGeneralized Anxiety DisorderPhobia, Social

Condition Hierarchy (Ancestors)

Mental DisordersPhobic Disorders

Study Officials

  • Karina S Peschardt, Ph.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 6, 2003

First Posted

June 9, 2003

Study Start

June 5, 2003

Study Completion

September 21, 2016

Last Updated

October 6, 2017

Record last verified: 2016-09-21

Locations

US(1)