Effect of CBD on the Brain

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06261450
Study type	Interventional
Source	Université de Sherbrooke
Contact	François Corbin, MD, Ph.D.
Phone	819-346-1110
Email	Francois.Corbin@USherbrooke.ca
Status	Not yet recruiting
Phase	Phase 2
Start date	April 1, 2024
Completion date	August 15, 2027

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05418049` - Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge	Phase 2
Enrolling by invitation	`NCT01364818` - Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment	N/A
Completed	`NCT01120626` - Randomized Controlled Study of Donepezil in Fragile X Syndrome	Phase 2
Completed	`NCT00965432` - A Single-Dose Study in Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107	Phase 1
Completed	`NCT01204151` - Teaching Math Skills to Individuals With Fragile X Syndrome	N/A
Active, not recruiting	`NCT00334971` - Aromatase Activity and Ovarian Growth Factors in African-American Versus Caucasian Women	N/A
Enrolling by invitation	`NCT06139172` - Promoting Prosocial Behavior in Syndromic Intellectual and Developmental Disabilities	N/A
Recruiting	`NCT04977986` - Clinical Study of Cannabidiol in Children, Adolescents, and Young Adults With Fragile X Syndrome	Phase 3
Active, not recruiting	`NCT04698551` - NIPD on cffDNA for Triplet Repeat Diseases
Completed	`NCT03722290` - Metformin in Children and Adults With Fragile X Syndrome	Phase 2
Completed	`NCT05030129` - Single Blind Study of Ergoloid Mesylates, 5-HTP and the Combination in Adult Males With Fragile X Syndrome	Phase 2
Recruiting	`NCT05957549` - Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG	N/A
Recruiting	`NCT04141163` - Metformin in Patients With Fragile X	Phase 1/Phase 2
Not yet recruiting	`NCT06081348` - Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders	Phase 2
Completed	`NCT00858689` - Add-on Pilot Trial of Minocycline to Treat Fragile X Syndrome	N/A
Enrolling by invitation	`NCT03655223` - Early Check: Expanded Screening in Newborns
Enrolling by invitation	`NCT03802799` - Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS	Phase 2/Phase 3
Recruiting	`NCT05295277` - Validation of Optical Genome Mapping for the Identification of Constitutional Genomic Variants in a Postnatal Cohort
Enrolling by invitation	`NCT03836300` - Parent and Infant Inter(X)Action Intervention (PIXI)	N/A
Completed	`NCT01725152` - Ganaxolone Treatment in Children With Fragile X Syndrome	Phase 2