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

NCT04821856 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-09-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Monash University

    collaborator OTHER

  • University of Sydney

    collaborator OTHER

  • Deakin University

    collaborator OTHER

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Daryl Efron · Murdoch Childrens Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-11
Primary Completion
2025-07-09
Completion
2025-08-19

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04821856 on ClinicalTrials.gov