NCT04821856

Evaluation of the Effectiveness of Cannabidiol in Treating Severe Behavioural Problems in Children and Adolescents With Intellectual Disability

A Randomized Placebo-controlled Trial of Cannabidiol to Treat Severe Behavioral Problems in Children and Adolescents With Intellectual Disability

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-site, double-blind, parallel group, randomized, placebo-controlled study of 140 participants comparing oral purified cannabidiol isolate (CBD) with placebo in reducing Severe Behavioral Problems (SBP) at 8 weeks in children aged 6 - 18 years with Intellectual Disability (ID). Eligible participants will be randomized 1:1 to receive either CBD or placebo.

Conditions

• Intellectual Disability
• Child Behavior Problem

Interventions

Type	Name	Description
DRUG	Cannabidiol Oil	Cannabidiol (CBD) isolate 100mg/ml in MCT oil oral solution, manufactured by THC Pharma
DRUG	Placebo	MCT oil and flavoring solution, also manufactured by THC Pharma

Timeline

• Start date: 2021-05-11
• Primary completion: 2025-07-09
• Completion: 2025-08-19
• First posted: 2021-03-30
• Last updated: 2025-09-03

Locations

3 sites across 1 country: Australia