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

Tracking Information
First Submitted Date April 9, 2009
First Posted Date April 10, 2009
Last Update Posted Date May 30, 2017
Study Start Date October 2005
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 9, 2009)
Fear-potentiated startle reflex [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00879515 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Examining Social, Emotional, and Cognitive Functioning in People With Fragile X and Down Syndromes
Official Title Genetics and Physiology of Social Anxiety in Fragile X
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Saliva samples collected at four time periods
Sampling Method Non-Probability Sample
Study Population Individuals with fragile X syndrome, Down syndrome, the fragile X premutation, and normal development
Condition
  • Anxiety Disorders
  • Child Developmental Disorders, Pervasive
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 5, 2013)
511
Original Estimated Enrollment
 (submitted: April 9, 2009)
320
Actual Study Completion Date September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00879515
Other Study ID Numbers 200210645
K23MH077554 ( U.S. NIH Grant/Contract )
DDTR B2-MBA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of California, Davis
Study Sponsor University of California, Davis
Collaborators National Institute of Mental Health (NIMH)
Investigators Not Provided
PRS Account University of California, Davis
Verification Date May 2017