Effects of cannabidiol in children with autism

Phase 1

Active, not recruiting

• Conditions: Autism Spectrum Disorder; Mental Health - Autistic spectrum disorders

• Registration Number: ACTRN12622000437763
• Lead Sponsor: Deakin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-18
• Last Update Posted: 2 August 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Male or female children aged between and including 5 to 12.

2. Diagnosis of Autism Spectrum Disorder (ASD) confirmed by The Autism Diagnostic Observation Schedule 2nd edition (ADOS-2). Children with autism will be identified in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V; APA, 2013) criteria.

3. Stable pharmacologic, educational, behavioural, and/or dietary interventions for 4 weeks prior to randomisation and for the duration of the study;

4. Presence of a parent/guardian who can provide consent for the participation of their child and complete assessments regarding the child's development and behaviour throughout the study;

5. Normal/corrected to normal hearing and vision.

6. IQ of 40 or higher.

Exclusion Criteria

1. Exposure to any investigational agent in the 30 days prior to randomization;

2. Prior chronic treatment with CBD, CBDV or an endocannabinoid treatment;

3. Diagnosis of a known genetic disorder (e.g., Prader-Willi Syndrome, Angelman Syndrome, Tuberous Sclerosis);

4. A known diagnosis of Rett Syndrome or Childhood Disintegrative Disorder, or marked sensory impairment such as deafness or blindness;

5. A primary psychiatric diagnosis other than ASD, including bipolar disorder, psychosis, schizophrenia, Post-Traumatic Stress Disorder (PTSD) or Major Depressive Disorder (MDD). These patients will be excluded due to potential confounding results;

6. A medical condition that severely impacts the participant’s ability to participate in the study, interferes with the conduct of the study, confounds interpretation of study results, or endangers the participant’s well-being;

7. Changes in allied health therapies, behavioural, or educational interventions within 4 weeks prior to randomisation other than those associated with school holidays;

8. Changes in medications or medication doses within four weeks of randomisation.

9. Contraindications to CBD100: hypersensitivity to cannabinoids, liver, kidney or cardiovascular disease, hypersensitivity to the excipient (MCT) or coconut allergy

10. Currently taking benzodiazepines, antiepileptic medications (e.g., sodium valproate, clobazam), and barbiturates.

11. IQ below 40 or severe intellectual disability.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Social Responsiveness Scale (SRS; Constantino & Gruber, 2005, SRS-2; 2012) <br>The SRS-2 is a reliable 65-item measure of symptom severity across five autism symptom domains: Social Awareness (8 items), Social Motivation (11 items), Social Cognition (12 items), Social Communication (22 items), and Repetitive Behaviours/Restricted Interests (12 items). Responses are measured on a 4-point scale from 1 (Not True) to 4 (Almost Always True). <br>[Baseline, 12 weeks post-commencement of CBD or MCT treatment];Neurophysiological measure, electroencephalography (EEG):<br>Event-related gamma power during social (Emotion processing) task processing.[Baseline, 12 weeks post-commencement of CBD or MCT treatment]