Modulation of the Brain Excitatory/Inhibitory (E/I) Balance in Autism Spectrum Disorder (ASD)

• Status: Unknown status
• Trial end date: 2020-02-02
• Target enrollment: 0
• Participant gender: All

Summary

This study investigates the brain response to a single acute dose of Arbaclofen, the R-enantiomer of the GABA-B agonist Baclofen, compared to a single dose of placebo in healthy men with and without autism spectrum disorder.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: King's College London
• Treatments: Baclofen

Criteria

Inclusion Criteria:

• ASD participants must pass diagnostic threshold for ASD on the Autism Diagnostic Interview-Revised (if and informant is available)

• ASD participants must be currently symptomatic on Autism Diagnostic Observation Schedule (ADOS)

• Age 18-60 years

• Can give informed consent

• medication free in the month preceding participation; but regular medication (used in a stable dose over the two months previous to participation) with drug which does not affect glutamate or GABA directly may be permitted

• IQ>70

Exclusion Criteria:

• IQ<70

• history of psychosis, co-morbid major mental illness, significant physical illness (heart disease, high blood pressure, seizures) habitual substance misuse (including alcohol)

• ASD caused by a known genetic syndrome e.g. Fragile X or 22q11 deletion syndrome,

• past/present treatment for epilepsy

• Women will be excluded from this pilot study to reduce heterogeneity in a small sample; avoid the issues around exposing women of reproductive age to a drug; and because pregnancy is a routine exclusion criteria for research MRI. Lastly, ASD is more common in men.

• Change of medication dose/start of a new pharmacological therapy in the month prior to participation