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This study will test the hypothesis that brain systems are differentially regulated by serotonin in individuals with and without Autism Spectrum Disorder.
Full description
To do this, the brain response to two single acute doses of partial serotonin (5HT)1A/2A receptor agonist psilocybin (COMP360) relative to a single dose of placebo (baseline serotonin activity) will be compared in healthy autistic and non-autistic adults.
Brain function will be assessed using a range of MRI (fMRI and MRS), EEG and sensory tasks. Unimodal and multimodal analyses will be conducted.
Please note that this study uses psilocybin as a probe of the serotonin system in a Case-Control science study and, following Scope protocol review, the U.K. MHRA confirmed that it is not a 'Clinical Trial of an Investigational Medicinal Product' (IMP) as defined by the EU Directive 2001/20/EC.
Enrollment
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Inclusion criteria
For all participants:
For individuals with ASD:
Exclusion criteria
For all participants:
Reproductive safety:
For individuals with ASD:
ASD caused by a known genetic syndrome, e.g. Fragile X, 22q11 deletion syndrome.
Currently treated for epilepsy
Primary purpose
Allocation
Interventional model
Masking
70 participants in 3 patient groups
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Central trial contact
Tobias Whelan; Grainne McAlonan
Data sourced from clinicaltrials.gov
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