Effect of CANnabidiol on Anxiety and GABAergic Function in Individuals with Fragile-X Syndrome
Launched by UNIVERSITÉ DE SHERBROOKE · Feb 7, 2024
Trial Information
Current as of July 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a substance called Cannabidiol (CBD) on individuals with Fragile X Syndrome (FXS), a genetic condition that can cause developmental challenges and anxiety. The research aims to see if CBD can improve the functioning of certain brain systems that are not working well in people with FXS, particularly those related to anxiety and aggressive behaviors. Since there is currently no cure for FXS, the hope is that this trial could lead to new treatment options that help manage symptoms and improve quality of life for those affected.
To participate in this study, individuals must be between the ages of 7 and 40 and have a confirmed diagnosis of FXS. They should also have a certain level of behavioral concerns, as measured by a specific scoring system, and must not have changed their medications in the past three months. Participants will take CBD orally and undergo tests to measure its effects on their brain function and behaviors related to FXS. It’s important to note that some people, such as those with certain medical conditions or on specific medications, may not be eligible to join the trial. This research is a promising step towards finding better ways to support individuals with Fragile X Syndrome.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Molecular diagnosis of FXS
- • Age 7 to 40 inclusively
- • Overall ABC-C score \> 20
- • Taking up to 3 psychoactive drugs
- • No therapeutic change for the last 3 months
- Exclusion Criteria:
- • Taking valproic acid
- • Taking clobazam
- • History of liver problems
- • aspartate aminotransferase (AST) or alanine transaminase (ALT), \> 3 times the reference values
- • Bilirubin \> 2 times the reference values
- • Absolute contraindication to the use of TMS and MRI (e.g. presence of metal in the body), will also be considered as an exclusion criterion.
About Université De Sherbrooke
The Université de Sherbrooke is a leading research institution in Canada, renowned for its commitment to advancing knowledge and innovation in various fields, including health sciences. With a focus on interdisciplinary collaboration, the university actively engages in clinical trials to explore new therapeutic interventions and improve patient care. Its research team comprises experienced professionals dedicated to ensuring the highest ethical standards and scientific rigor in clinical research. The Université de Sherbrooke strives to translate research findings into practical solutions that enhance health outcomes and contribute to the advancement of medical science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported