- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00879515
Examining Social, Emotional, and Cognitive Functioning in People With Fragile X and Down Syndromes
Genetics and Physiology of Social Anxiety in Fragile X
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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California
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Sacramento, California, Forenede Stater, 95817
- M.I.N.D. Institute, University of California, Davis
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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
|
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3
Males and females with Down syndrome, ages 5 to 25 years old
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4
Males and females with normal development, ages 5 to 25 years old
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Fear-potentiated startle reflex
Tidsramme: 1 year
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Patologiske processer
- Sygdomme i nervesystemet
- Neurologiske manifestationer
- Neuroadfærdsmæssige manifestationer
- Medfødte abnormiteter
- Genetiske sygdomme, medfødte
- Intellektuel handicap
- Neuroudviklingsforstyrrelser
- Børns udviklingsforstyrrelser, gennemgående
- Abnormiteter, multiple
- Kromosomlidelser
- Sygdom
- Angstlidelser
- Autismespektrumforstyrrelse
- Downs syndrom
- Udviklingshæmning
Andre undersøgelses-id-numre
- 200210645
- DDTR B2-MBA (Andet bevillings-/finansieringsnummer: National Institute of Mental Health)
- K23MH077554 (U.S. NIH-bevilling/kontrakt)
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