Status:
TERMINATED
Neuroimaging GABA Physiology in Fragile X Syndrome
Lead Sponsor:
Stanford University
Conditions:
Fragile X Syndrome (FXS)
Idiopathic Intellectual Developmental Disorder (IDD)
Eligibility:
MALE
18-30 years
Phase:
PHASE1
Brief Summary
The investigators wish to compare the brain distribution of GABA(A) receptors and GABA levels in young adult males with Fragile X Syndrome compared to idiopathic intellectual developmental disorder. T...
Detailed Description
Fragile X syndrome (FXS) is the most common genetic cause of autism spectrum disorder (ASD). Converging evidence suggests that GABAergic dysfunction occurs in FXS. The investigators wish to examine br...
Eligibility Criteria
Inclusion
- Inclusion Criteria for participants with FXS:
- Have an established diagnosis of FXS (full mutation with aberrant FMR1 methylation) by genetic testing
- Diagnosis of intellectual disability
- Males who are physically healthy
- Age 18 to 30 years inclusive
- IQ between 40 and 80 points
- Ability to remain seated for more than 10 minutes
- Ability to travel to Stanford
- Exclusion criteria for participants with FXS:
- Diagnosis of a known genetic disorder (other than FXS).
- Active medical problems such as unstable seizures, congenital heart disease, endocrine disorders.
- Significant sensory impairments such as blindness or deafness.
- DSM-5 diagnosis of other severe psychiatric disorder such as bipolar disorder or schizophrenia.
- Pre-term birth (\<34 weeks' gestation) or low birth weight (\<2000g).
- Current use of benzodiazepines.
- Contraindication for PET or MRI.
- Inclusion criteria for participants with IDD:
- Age 18 to 30 years inclusive
- Adults who are physically healthy
- No significant recent changes in psychosocial stressors per history
- Diagnosis of intellectual disability
- IQ between 40 and 80 points
- Ability to remain seated for more than 10 minutes
- Ability to travel to Stanford
- Exclusion Criteria for participants with IDD:
- Genetic diagnosis of FXS.
- Active medical problems such as unstable seizures, congenital heart disease, endocrine disorders.
- Significant sensory impairments such as blindness or deafness.
- DSM-5 diagnosis of other severe psychiatric disorder such as bipolar disorder or schizophrenia.
- Pre-term birth (\<34 weeks' gestation) or low birth weight (\<2000g).
- Current use of benzodiazepines.
- Contraindication for PET or MRI.
Exclusion
Key Trial Info
Start Date :
November 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2018
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04308954
Start Date
November 1 2016
End Date
December 6 2018
Last Update
January 28 2021
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305