Clinical Trial Search

Primary: Pediatric Anxiety Rating Scale (Measures the Severity of Anxiety Symptoms) — 16.33; 17.62; 11.58; 16.05 units on a scale

Primary: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score — -8.4; -12.4; -13.2; -14.4 units on a scale

Primary: Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score — -11.4; -7.5 units on a scale

Primary: Change From Baseline in the Pervasive Developmental Disorder-Behavioral Inventory (PDDBI) - Autism Composite Score — -4.5; -6.4 units on a scale — p=0.5

Primary: Pediatric Anxiety Rating Scale. — 11.62; 14.04 units on a scale — p=.04

Primary: Number of Participants Improved as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2) — 11; 3 participants

Primary: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score — -5.0; -12.9 units on a scale

Primary: Clinical Global Impressions-Improvement — 1.8 units on a scale

Primary: Change in Score on Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale — 68.6; 71.8; 53.4; 57 T-score

Primary: Change From Baseline in Anxiety Severity on the Pediatric Anxiety Rating Scale After 16 Weeks of Treatment. — 3.43; 3.47; 3.28; 2.13 units on a scale

Primary: Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment. — 9.73; 3.18 units on a scale — p=0.0275

Primary: Number of Confirmed Social Responsiveness Scale (SRS) Responders — 517; 351 participants

Primary: Clinical Global Impression Improvement (CGI-AD) — 3.83; 4.25; 2.67; 4.25 score on a scale

Primary: Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks — 7.6; -0.6 units on a scale

Primary: Pediatric Anxiety Rating Scale — 10.94; 13.93 units on a scale

Primary: Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase — -4.9; -3.2 score on a scale

Primary: Social Responsiveness Scale (SRS) Change — -13.39; -17.00 units on a scale — p=0.45

Primary: Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale — 3; 1 Participants

Primary: Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome…

Primary: Pediatric Anxiety Rating Scale — 7.79; 15.06 units on a scale

Primary: Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score — -3.2 units on a scale

Primary: Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases) — 69.0; 67.5; 66.7 Percentage of…

Primary: A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion — 0; 0; 0; 0 participants

Primary: Number of Participants Reporting Improvement on the Clinical Global Impression — 1; 10 Participants

Primary: Number of Participants Who Could Tolerate Twice Daily Oxytocin — 13; 11 Participants

Primary: ADHD Rating Scale (ADHDRS)-Home Version Total Score (Randomized Phase) — 28.7; 34.0 units on a scale

Primary: Clinical Global Impression -- Improvement (CGI-I) Scale — 5; 3 participants — p=<.35

Primary: Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale — -3.5; -7.4; -12.4 units on a scale — p=<0.001

Primary: Clinical Features of Concordant vs Discordant Groups — 76.18; 89.85; 14.96; 13.94 units on a scale

Primary: Change in Social Communication as Measured by the Vineland Adaptive Behavior Scales, Third Edition (VABS-3) — 3.13; 1.98 score on a scale — p=0.83