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Trial record 21 of 214 for:    Developmental Disabilities | NIH

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

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. Identifier: NCT00879515
Recruitment Status : Completed
First Posted : April 10, 2009
Last Update Posted : May 30, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease
Anxiety Disorders Child Developmental Disorders, Pervasive

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.

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Study Type : Observational
Actual Enrollment : 511 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Genetics and Physiology of Social Anxiety in Fragile X
Study Start Date : October 2005
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Males and females with fragile X syndrome, ages 5 to 25 years old
Males and females with the FMR1 premutation, ages 5 to 25 year old
Males and females with Down syndrome, ages 5 to 25 years old
Males and females with normal development, ages 5 to 25 years old

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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

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 identifier (NCT number): NCT00879515

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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)

Additional Information:
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Responsible Party: University of California, Davis Identifier: NCT00879515     History of Changes
Other Study ID Numbers: 200210645
K23MH077554 ( U.S. NIH Grant/Contract )
First Posted: April 10, 2009    Key Record Dates
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:
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Developmental Disabilities
Intellectual Disability
Child Development Disorders, Pervasive
Down Syndrome
Anxiety Disorders
Autism Spectrum Disorder
Pathologic Processes
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Neurodevelopmental Disorders