Please select the outcome measures that correspond to the clinical trial below.
Title: Methylphenidate for Hyperactivity and Impulsiveness in Children and Adolescents With Pervasive Developmental Disorders
Brief Summary: This study will evaluate the efficacy and safety of methylphenidate for treating hyperactivity, impulsiveness, and distractibility in 60 children and adolescents with Pervasive Developmental Disorders (PDD). Methylphenidate (Ritalin)is approved by the Food and Drug Administration for the treatment of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). Data supporting its safety and effectiveness in treating ADHD symptoms in PDD are limited. Children and adolescents who do not show a positive response to methylphenidate will be invited to participate in a pilot study of the non-stimulant medication guanfacine (Tenex).


Options:
A: Clinical Global Impressions Scale - Improvement - Social (6 Weeks); Repetitive Behavior Scale - Revised (6 Weeks); Diagnostic Analysis of Nonverbal Accuracy, Paralanguage Test (6 Weeks)
B: hyperactivity, impulsiveness, and distractibility
C: Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs (From Screening (up to 42 days prior to treatment start) through Week 52 (end of study) for SAEs; from Week 0 (Baseline) through Week 52 (End of Study) for AEs); Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52 (Baseline, Week 8, Week 26, Week 52); Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52 (Baseline, Week 8, Week 26, Week 52); Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Week 8, Week 26, Week 52, and Endpoint (Baseline, Week 8, Week 26, Week 52); Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities (At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52); Number of Participants With Potentially Clinically Relevant Laboratory Hematology Abnormalities (At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52); Number of Participants With Potentially Clinically Relevant Laboratory Chemistry Abnormalities (At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52); Number of Participants With Potentially Clinically Relevant Eletrocardiograph (ECG) Abnormalities (At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52); Number of Potentially Clinically Relevant Vital Sign Abnormalities (At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)); Mean Change From Baseline in Patient Weight (At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)); Mean Change From Baseline by Time Period in Body Weight Z-Score (At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)); Mean Change From Baseline in Patient Body Mass Index (BMI) (At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)); Mean Change From Baseline By Time Period in BMI Z-Score (At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint))
D: Clinical Global Improvement (Week 12)

Answer: B