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Trial · NCT03204786

Registered outcomes48

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
SecondaryChange From Baseline on Urine Clinical Labs (Osmolality) During Treatment.baseline to 4-week, 8-week, and 12-week
SecondaryChange From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment.Up to 12 weeks
SecondaryChange From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment.Up to 12 weeks
SecondaryChange From Baseline on Vital Signs (Pulse) During Treatment.Up to 12 weeks
SecondaryChange From Baseline on Height During Treatment.baseline to 4-week, 8-week, and 12-week
SecondaryChange From Baseline on Weight During Treatment.baseline to 4-week, 8-week, and 12-week
SecondaryChange From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment.Up to 12 weeks
The DOTES evaluates a subset of symptoms related to various medical conditions. The clinician assesses intensity (0=Not assessed, 1=Not present, 2=Mild, 3=Moderate, 4=Severe), relatedness (0=None, 1=Remote, 2=Possible, 3=Probable, 4=Defined), and action taken (0=None, 1=Increased , 2=Contractive Rx, 3=Change Dose, 4=Change Dose Plus Contractive Rx, 5=Suspend Rx, 6=Discontinue Rx). Side effects are included that have increased in severity, become more likely to be related, or require action. Change from baseline is reported as the number of participants with change in these side effects during treatment.
SecondaryNumber of Participants Reporting Aggression Using the Overt Aggression Scale (OAS) During Treatment.baseline, 4-weeks, 8-weeksThe scale evaluates the child participant's aggression. The number of children who exhibited aggression as reported by the parent is reported.
SecondaryAdverse Event SeverityUp to 12 weeksAdverse events collated according to intensity for each pre-allocated treatment group.
OtherBaseline Vasopressin Concentration Predicting Primary and Secondary Behavioral Outcome Measures.4-week; 8-week
OtherChange From Baseline in Vineland Adaptive Behavior Scales, Third Edition (VABS-3) - Social Skills and Relationships Domain During Treatment.4-week; 8-week
OtherChange From Baseline in Parent Rated Pediatric Quality of Life (PedsQL) Inventory Scores During Treatment.4-week; 8-week
OtherChange From Baseline on Eye Gaze Assessment (Eye Tracking) During Treatment.4-week; 8-week
OtherChange From Baseline on the Developmental Neuropsychological Assessment, Second Edition (NEPSY-II) Theory of Mind Test During Treatment.4-week; 8-week
OtherChange From Baseline the Diagnostic Analysis of Nonverbal Accuracy, Second Edition (DANVA-2) Child Voices Prosody Test During Treatment.4-week; 8-week
OtherChange From Baseline in Parent Rated Stanford Social Motivation Scale (Also Known as the Stanford Social Dimensional Scale) Total Scores During Treatment.4-week; 8-week
OtherChange From Baseline in Parent Rated Anxiety Scale - Autism Spectrum Disorder (PRAS-ASD) Score During Treatment.4-week; 8-week
OtherChange From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Social Avoidance Factor Score During Treatment.4-week; 8-week
OtherChange From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Emotion Recognition Factor Score During Treatment.4-week; 8-week
OtherChange From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Interpersonal Relatedness Factor Score During Treatment.4-week; 8-week

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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