Does cannabidiol reduce severe behavioural problems in youth with intellectual disability? Feasibility and pilot randomised placebo-controlled trial.

Phase 1

Completed

• Conditions: Intellectual Disability; Severe Behaviour Problems; Mental Health - Other mental health disorders

• Registration Number: ACTRN12618001852246
• Lead Sponsor: Murdoch Children's Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-14
• Study Completion: 2019-09-30
• Last Update Posted: 16 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Each patient must meet all of the following criteria to be enrolled in this study:
1.Males and females aged 8 – 16 years of age;
2.DSM-5 diagnosis of ID.
a.Full scale IQ < 70 on standardized cognitive assessment on verified records of testing performed within two years of enrolment. In the event that records of prior testing are unavailable or the assessment was more than 2 years prior, IQ will be estimated using the Wechsler Abbreviated Scale of Intelligence-II.
b.Deficit in adaptive function (basis for severity rating of ID in DSM-5) in at least one activity of life: Vineland Adaptive Behavior Scales completed by interview with the parent or guardian; derives scores in Communication, Daily Living Skills and Socialization domains, and a Global Adaptive score.
3.SBP: Defined as:
a. scores of 18 or higher on the Aberrant Behavior Checklist-Irritability subscale (ABC-I), and
b.moderate or higher on the Clinical Global Impressions-Severity scale.
4.Consistent pattern of frequent SBP symptoms for > 3 months (parent interview).
5.No changes in either medication or other interventions in the 4 weeks prior to randomization.
6.Written informed consent from parent or legal guardian.
7.Has the ability to comply with the protocol requirements, in the opinion of the investigator.

Exclusion Criteria

1.Non-English speaking parents.
2.Psychosis, bipolar disorder, major depressive disorder, obsessive compulsive disorder.
3.Taking anti-epileptic medications which interact with CBD (e.g. clobazam, topiramate, zonisamide)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recruitment feasibility: Recruitment rate (% of eligible participants enrolled)[Data collected throughout the recruitment period or until the desired sample size has been recruited.];Acceptability of study procedures (tolerability of the study medication, study visits, blood tests, parent questionnaire completion): assessed through a parent-rated questionnaire that was designed specifically for this study.[30 days post-cessation of the study medication (104 days after randomisation).];Protocol completion: Withdrawals and treatment discontinuations will be recorded by the investigators with reasons.[Data will be collected throughout the duration of the study, from commencement to 74 days post-commencement.]