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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 9, 2009 | ||||||||
| Last Updated Date | April 10, 2009 | ||||||||
| Start Date ICMJE | October 2005 | ||||||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Fear-potentiated startle reflex [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00879515 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Examining Social, Emotional, and Cognitive Functioning in People With Fragile X and Down Syndromes | ||||||||
| Official Title ICMJE | 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. |
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| 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 Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case Control, Cross-Sectional | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 320 | ||||||||
| Estimated Completion Date | September 2010 | ||||||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 5 Years to 25 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00879515 | ||||||||
| Responsible Party | David R. Hessl, PhD, Associate Professor, University of California, Davis | ||||||||
| Study ID Numbers ICMJE | K23 MH077554, DDTR B2-MBA | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | April 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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