- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00879515
Examining Social, Emotional, and Cognitive Functioning in People With Fragile X and Down Syndromes
Genetics and Physiology of Social Anxiety in Fragile X
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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California
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Sacramento, California, Förenta staterna, 95817
- M.I.N.D. Institute, University of California, Davis
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Fear-potentiated startle reflex
Tidsram: 1 year
|
1 year
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Patologiska processer
- Sjukdomar i nervsystemet
- Neurologiska manifestationer
- Neurobehavioral manifestationer
- Medfödda abnormiteter
- Genetiska sjukdomar, medfödda
- Intellektuell funktionsnedsättning
- Neuropsykiatriska funktionsnedsättningar
- Barnutvecklingsstörningar, genomgripande
- Avvikelser, flera
- Kromosomstörningar
- Sjukdom
- Ångeststörningar
- Autismspektrumstörning
- Downs syndrom
- Utvecklingsstörning
Andra studie-ID-nummer
- 200210645
- DDTR B2-MBA (Annat bidrag/finansieringsnummer: National Institute of Mental Health)
- K23MH077554 (U.S.S. NIH-anslag/kontrakt)
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