Abstracts

Rationale: Studies indicate that Cannabidiol (CBD) may be safe and effective in treating epilepsy. The potential benefits or adverse effects of CBD involving behavior in children need to be determined. Methods: Participants (N = 77) between the age of 3-19 years with pharmacoresistant epilepsy were enrolled in an open label study of a pharmaceutical formulation of CBD (Epidiolex^®; GW Research Ltd) as an add-on treatment of epilepsy.  In addition to assessing several baseline medical, cognitive, and psychosocial variables, assessment of behavior was performed. Accrual occurred over time and those with one year of participation in the study (35 participants) were re-assessed to determine if there had been any significant changes in behavior.  Behavioral status was assessed with the Achenbach Child Behavior Checklist (A-CBC).  Results: Behavioral data were available for 35 participants who were in the study for at least one year.  There were no significant changes in overall behavioral status as measured by the Total Problems T-score score from the CBC (mean change from baseline = .97; t = .585; p = .563).  Internalizing behaviors were reported as improved at a level that approached significance after one year (mean improvement in Internalizing Problems T-score from baseline = 3.03; t = 1.83; p = .076). Externalizing behaviors were unchanged (mean change in Externalizing Problems T-score from baseline = .11; t = .099; p = .92) Conclusions: Data collection continues in this study, but based upon preliminary analyses, CBD as an add-on drug for the treatment of pharmacoresistant epilepsy in a pediatric population does not appear to be associated with adverse effects involving behavior in patients who completed one year of treatment. Funding: Study funding provided by the State of Alabama through Carly’s Law (SB174).