Pilot study of cannabidiol (CBD) in children with Intellectual Disability (ID) and Severe Behavioural Problems (SBP)

Murdoch Children's Research Institute0 个研究点目标入组 8 人开始时间: 2018年11月14日最近更新: 2020年3月16日

适应症

试验速览

暂无简介。

•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.

•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)

发起方