[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536178":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":25,"responsibleParty":41,"collaborators":45,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":25,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":81,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":25},{"fullName":5,"class":6},"Université de Sherbrooke","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"CBD first","EXPERIMENTAL","A single dose of CBD dose administered followed by a dose of placebo 3 weeks later.",[13,14],"Drug: CBD Oral Solution (eCBD system Target)","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Placebo first","A single dose of placebo dose administered followed by a dose of CBD 3 weeks later.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","CBD Oral Solution (eCBD system Target)","Participants receive orally 6 ml of CBD Oral Solution (100 mg \u002F ml; 60 mg \u002F kg; max 600 mg of CBD) followed by 6 ml of a placebo composed of the inactive ingredients of CBD Oral Solution 3 weeks later.",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","Participants receive orally 6 ml of a placebo composed of the inactive ingredients of CBD Oral Solution followed by 6 ml of Oral CBD Solution (100 mg \u002F ml; 60 mg \u002F kg; max 600 mg of CBD)",[9,16],[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"François Corbin, MD, Ph.D.","CONTACT","819-346-1110","15801","Francois.Corbin@USherbrooke.ca",{"name":38,"role":33,"phone":34,"phoneExt":39,"email":40},"Samantha Cote","70184","Samantha.cote@usherbrooke.ca",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Francois Corbin","Full professor, Department of biochemistry",[46,49,52],{"name":47,"class":48},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":50,"class":51},"Jazz Pharmaceuticals","INDUSTRY",{"name":53,"class":6},"Centre de recherche du Centre hospitalier universitaire de Sherbrooke","100536178","phase-2-effect-of-cbd-on-the-brain-100536178",false,"NCT06261450","Effect of CBD on the Brain","Effect of CBD on the GABAergic System in Patients with Fragile X Syndrome.","Inclusion Criteria:\n\nEligibility criteria for FXS participants will include:\n\n* age between 7 and 55 years, molecular diagnosis of FXS,\n* intelligence quotient (IQ) \\\u003C70,\n* aberrant behavior questionnaire score (ABC-C) \\> 20,\n* \\\u003C3 psychoactive drugs, drug stable for \\> 3 months.\n\nEligibility criteria for the control group:\n\n* 18 and 55 years old,\n* be in good general health, with no history of neurological or psychiatric disorders.\n\nEligibility Criteria for all Participants:\n\n* A minimum weight of 60 kg;\n* no history of liver problems (A complete blood profile to measure liver enzyme levels (bilirubin, aspartate aminotransferase (AST), argininosuccinate lyase (ASL), alanine transaminase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT)) will be obtained before randomization for all participants).\n\nExclusion Criteria:\n\n* The presence of an absolute contraindication to the use of TMS and MRI \u002F MRS (ie presence of metal in the head).\n* Individuals with ALT \u002F ASL levels greater than 3 times the upper normal baseline, or if bilirubin exceeds 2 times the upper baseline,",true,"ALL","7 Years","55 Years",{"count":66,"type":67},50,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","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.",[73],"Fragile X Syndrome",[75,76,77,78,79,80],"MRI","Cannabidiol","GABA","FXS","MRS","TMS","NOT_YET_RECRUITING","2025-02-13",{"date":84,"type":85},"2025-02-17","ACTUAL",{"date":87,"type":67},"2025-05-01",{"date":89,"type":67},"2027-12-15",{"name":5,"class":6}]