ABSTRACT
Background/Objective: This continuation study follows positive results of the Phase IIb study and aims to supplement findings with additional scale data and unblinded group membership. The goal is to further assess the potential impact of COVID-19 restrictions on symptom severity in additional domains captured by the Children's Depression Rating Scale-Revised (CDRS-R);Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS);Swanson, Nolan, and Pelham (SNAP-IV);Pediatric Anxiety Scale (PARS);and Clinical Global Impression Scale-Severity (CGI-S). Design(s): Data was partitioned using the date of March 11, 2020. Baseline outcome measure data was analyzed. Additionally, individual item scores were considered across the two time periods, as were treatment group assignments. Descriptive statistics were computed using SPSS 27.0 and included mean, standard deviation, variance, and distribution measures. Result(s): YGTSS mean values under consideration did not appear to change significantly between the time periods before and after COVID-19 restrictions began, with total scores of 67.2 and 66.7, respectively. Mean baseline CY-BOCS scores of 7.45 (before) and 7.55 (after) also showed similar stability to PARS (11.7 before and 12 after) and CDRS (29 before and 27.5 after), with similar stability noted in the CGI-S. Conclusion(s): While clinically, it might be typical for symptoms of Tourette's syndrome to be susceptible to stressors, this was not demonstrated in relation to the COVID-19 pandemic by any significant differences in primary tic assessments or related/comorbid disorders. There did not appear to be significant differences in YGTSS, CY-BOCS, PARS, CDRS, or CGI-S domain scores or individual item scores before or after COVID-19 restrictions were in place.