Effect of CBD on the Brain

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age7-55
SponsorUniversité de Sherbrooke

About this trial

This proposal focuses on the therapeutic relevance of the endocannabinoid (eCB) system for the treatment of Fragile-X syndrome (FXS), the primary hereditary cause of autism spectrum disorder (ASD). Although most individuals with FXS have moderate to severe intellectual disability (ID), caregivers are mainly concerned about aggressive behavior and anxiety problems, hallmark features of the condition. Concurrent lines of evidence suggest that targeting the endocannabinoid (eCB) system by administration of cannabidiol (CBD) could upregulate GABAergic functions and correct inhibitory deficits presumed responsible for the neuropsychiatric phenotype of FXS. However, the eCB system and its effect on the brain remains unexplored in FXS patients. This clinical trial aims to define the therapeutic relevance of the eCB system for FXS using a multimodal neuroimaging approach to finely characterize the acute effects of oral CBD on the principal inhibitory neurotransmitter system (GABA) in a large cohort of FXS patients.

Eligibility criteria

Qualifiers

age between 7 and 55 years, molecular diagnosis of FXS,

intelligence quotient (IQ) <70,

aberrant behavior questionnaire score (ABC-C) > 20,

<3 psychoactive drugs, drug stable for > 3 months.

Disqualifiers

The presence of an absolute contraindication to the use of TMS and MRI / MRS (ie presence of metal in the head).

Individuals with ALT / ASL levels greater than 3 times the upper normal baseline, or if bilirubin exceeds 2 times the upper baseline,

Trial design

Treatments tested in this trial

  • CBD Oral Solution (eCBD system Target)
  • Placebo

Treatment groups

50 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Université de Sherbrooke

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Jazz Pharmaceuticals

Collaborator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborator