Intranasal Vasopressin Treatment in Children With Autism

Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment.

Time frame · baseline, 4-week, 8-week

Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. The SRS-2 is reported as a total score (T-Score Range: 37 to above 90), and the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5-compatible Social Communication and Interaction (SCI) score (T-Score Range: 36 to above 90) and Restricted Interests and Repetitive Behavior (RRB) score (T-Score range: 41 to above 90). A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores correspond to greater symptom levels (≤ 59: within normal limits; 60-65: mild range; 66-75: moderate range; ≥ 76: severe range). Change is reported as 4-week minus the baseline score, and 8-week minus the 4-week score. For this outcome, the baseline score is the average of the screening visit and baseline visit (average approximately 2 to 3 weeks after the screening visit).

Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment.

Time frame · baseline; 4-week; 8-week

Clinician assessment of CGI severity (CGI-S) and CGI improvement (CGI-I) scores. * Higher scores on the CGI-S mean greater social and communication deficits (range: 1 to 7). * Lower scores on the CGI-I correspond to greater improvement in the areas assessed in the CGI-S, and higher scores correspond to worsening (range: 1 to 7). There is no baseline score for the CGI-I, it represents the clinician's subjective assessment of change.

Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment.

Time frame · baseline; 4-week; 8-week

Score range: 0 to 28; higher scores mean better ability to read emotions and lower scores mean worse ability to read emotions.

Change From Baseline on the Facial Emotion Recognition Test During Treatment.

Time frame · baseline; 4-week; 8-week

Score range: 0 to 42; higher scores mean better facial emotion recognition abilities. Lower scores mean worse facial emotion recognition abilities.

Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.

Time frame · baseline; 4-week; 8-week

Score range: 0 to 129; higher scores on the RBS-R mean higher levels of repetitive and restricted behaviors.

Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment.

Time frame · baseline; 4-week; 8-week

Scale measuring severity of anxiety symptoms. Score range: 0 to 114; higher scores mean higher levels of anxiety, lower scores mean lower levels of anxiety.

Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment.

Time frame · baseline to 4-week, 8-week, and 12-week

Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment.

Time frame · baseline to 4-week, 8-week, and 12-week

Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment.

Time frame · baseline to 4-week, 8-week, and 12-week

Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment.

Time frame · baseline to 4-week, 8-week, and 12-week

Change From Baseline on Blood Clinical Labs (Sodium) During Treatment.

Time frame · baseline to 4-week, 8-week, and 12-week