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Clinical Trials/NCT00879515
NCT00879515
Completed
Not Applicable

Genetics and Physiology of Social Anxiety in Fragile X

University of California, Davis1 site in 1 country511 target enrollmentOctober 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety Disorders
Sponsor
University of California, Davis
Enrollment
511
Locations
1
Primary Endpoint
Fear-potentiated startle reflex
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

By testing physiological responses to anxiety in people with nervous system developmental disorders, this study will identify specific physiological characteristics associated with response to anxiety treatments.

Detailed Description

Anxiety is a common and significant problem for people suffering from disorders of nervous system development, including fragile X syndrome. There are few validated treatments for anxiety in people with these disorders, in part because the biological basis of anxiety in neurodevelopmental disorders has not been clearly described. This study will evaluate the physiological responses of people with fragile X syndrome, Down syndrome, and the fragile X premutation (a mild version of the genes that cause fragile X syndrome) to a variety of sensory, emotional, and social stimuli. By analyzing the data collected for this study, researchers aim to identify physiological characteristics linked to subgroups within the disorders, demonstrate links between physiological responses and behavioral or psychiatric symptoms, and measure physiological changes in people receiving treatment for their disorders. Participation in this study will include one testing session, which will take between 3 and 3.5 hours. Participants who receive treatment for their anxiety may be asked to complete this testing a second time, after their treatment. During the testing session, sensors will be placed on participants' skin in several locations to measure heart rate, sweat response, and eye-blinks. Participants will then be asked to respond to multiple stimuli: sounds, lights, smells, pictures that elicit different types of emotions, an interaction with an unfamiliar person, and specialized toys. In addition, participants will undergo blood testing and have several samples of their saliva collected on the day of the testing session. Participants will also be asked to collect additional saliva samples at home three times a day on 4 different days. Child participants and their parents may also be asked to complete questionnaires and interviews about behavioral and emotional problems.

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
September 2010
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Fragile X premutation or fragile X syndrome, measured by DNA testing; Down syndrome, confirmed by chromosomal analysis; or normally developing control
  • Normal hearing

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Fear-potentiated startle reflex

Time Frame: 1 year

Study Sites (1)

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