Subjects
cognitive and/or behavioral disturbances, intellectual disability, psychosis, depressive disorder, autism spectrum disorder, oppositional defiant disorder, disruptive mood dysregulation disorder, bipolar I or II disorder, obsessive-compulsive disorder
DISORDER, GENETIC DISORDER, TOURETTE SYNDROME
Subjects who had not participated in the previous laboratory classroom study were required to be at least 6 years and <13 years of age at the start of the DO phase in the present study. Subjects rolling over from the laboratory classroom study were included if they had reached 13 years of age by the time they entered into the present study. All subjects had to be in overall good health without any clinically relevant abnormalities determined by physical and neurological examinations, vital signs, electrocardiograms (ECGs), medical history, and clinical laboratory values. New subjects must have had a body weight of ≥21 kg at screening. The rollover subjects had the same body weight requirements when enrolling in the earlier pivotal study. At least one parent or legal guardian of the subject had to give voluntary written permission to participate in the study, and the subject had to give written or oral approval before participating in the study.New subjects had to meet Subjects were excluded if they had any diagnosis of bipolar I or II disorder, major depressive disorder, conduct disorder, or obsessive-compulsive disorder or any history of psychosis, autism spectrum disorder, disruptive mood dysregulation disorder, intellectual disability, Tourette syndrome, or confirmed genetic disorder with cognitive and/or behavioral disturbances. Subjects with oppositional defiant disorder were permitted to enroll in the study provided that it was not the primary focus of treatment and, in the opinion of the investigator, was mild to moderate and as long as eligible subjects with oppositional defiant disorder were appropriate and cooperative during screening.