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Examining Social, Emotional, and Cognitive Functioning in People With Fragile X and Down Syndromes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00879515
First Posted: April 10, 2009
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, Davis
  Purpose
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.

Condition
Anxiety Disorders Child Developmental Disorders, Pervasive

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Genetics and Physiology of Social Anxiety in Fragile X

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Fear-potentiated startle reflex [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Saliva samples collected at four time periods

Enrollment: 511
Study Start Date: October 2005
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Males and females with fragile X syndrome, ages 5 to 25 years old
2
Males and females with the FMR1 premutation, ages 5 to 25 year old
3
Males and females with Down syndrome, ages 5 to 25 years old
4
Males and females with normal development, ages 5 to 25 years old

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals with fragile X syndrome, Down syndrome, the fragile X premutation, and normal development
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879515


Locations
United States, California
M.I.N.D. Institute, University of California, Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00879515     History of Changes
Other Study ID Numbers: 200210645
K23MH077554 ( U.S. NIH Grant/Contract )
DDTR B2-MBA
First Submitted: April 9, 2009
First Posted: April 10, 2009
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by University of California, Davis:
Fragile X Premutation
Fragile X Syndrome
Down Syndrome

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Down Syndrome
Developmental Disabilities
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Mental Disorders
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Neurodevelopmental Disorders