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Trial · NCT03197662

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in Efficacy of Peptide Intranasal Oxytocin (IN-OXT)From Randomization at Baseline until Endpoint at Week 8 (Change over 8 weeks)Data was unable to be collected from 2 participants in the matched Placebo study arm who withdrew from the study.score on a scaleMEAN
SECONDARYChange in Repetitive BehaviorFrom Randomization at Baseline until Endpoint at Week 8 (Change over 8 weeks)Data was unable to be collected from 2 participants in the matched Placebo study arm who withdrew from the study.score on a scaleMEAN
SECONDARYChange in Rigid BehaviorFrom Randomization at Baseline until Endpoint at Week 8 (Change over 8 weeks)Data was unable to be collected from 2 participants in the matched Placebo study arm who withdrew from the study.score on a scaleMEAN
SECONDARYChange in Body WeightFrom Randomization at Baseline until Endpoint at Week 8 (Change over 8 weeks)Data was missing or unable to be collected from 3 participants in the matched Placebo study arm (including the 2 participants who withdrew from the study).kilogramsMEAN
SECONDARYBody Composition8 weeksData was missing or unable to be collected from 4 participants in the IN-OXT study arm and 8 participants in the matched Placebo study arm (including the 2 participants who withdrew from the study).percentage of fatMEDIAN
SECONDARYChange in Body Mass Index (BMI)From Randomization at Baseline until Endpoint at Week 8 (Change over 8 weeks)Data was missing or unable to be collected from 1 participant in the IN-OXT arm and 3 participants in the matched Placebo study arm (including the 2 participants who withdrew from the study).kg/m2MEAN
SECONDARYChange in Quality of Life (QOL) and Caregiver Burden as Determined by the World Health Organization Quality of Life (WHOQOL-BREF) Questionnaire: Domain 1 (Physical Health)From Randomization at Baseline until Endpoint at Week 8 (Change over 8 weeks)Data was missing or unable to be collected from 1 participant in the IN-OXT arm and 3 participants in the matched Placebo study arm (including the 2 participants who withdrew from the study).score on a scaleMEAN
SECONDARYChange in Quality of Life (QOL) and Caregiver Burden as Determined by the World Health Organization Quality of Life (WHOQOL-BREF) Questionnaire - Domain 2 (Psychological Health)From Randomization at Baseline until Endpoint at Week 8 (Change over 8 weeks)Data was missing or unable to be collected from 1 participant in the IN-OXT arm and 3 participants in the matched Placebo study arm (including the 2 participants who withdrew from the study).score on a scaleMEAN
SECONDARYChange in Quality of Life (QOL) and Caregiver Burden as Determined by the World Health Organization Quality of Life (WHOQOL-BREF) Questionnaire - Domain 3 (Social Relationships)From Randomization at Baseline until Endpoint at Week 8 (Change over 8 weeks)Data was missing or unable to be collected from 1 participant in the IN-OXT arm and 3 participants in the matched Placebo study arm (including the 2 participants who withdrew from the study).score on a scaleMEAN
SECONDARYChange in Quality of Life (QOL) and Caregiver Burden as Determined by the World Health Organization Quality of Life (WHOQOL-BREF) Questionnaire - Domain 4 (Environment)From Randomization at Baseline until Endpoint at Week 8 (Change over 8 weeks)Data was missing or unable to be collected from 1 participant in the IN-OXT arm and 3 participants in the matched Placebo study arm (including the 2 participants who withdrew from the study).score on a scaleMEAN
SECONDARYChange in Caregiver StrainFrom Randomization at Baseline until Endpoint at Week 8 (Change over 8 weeks)Data was unable to be collected from 2 participants in the matched Placebo study arm who withdrew from the study.score on a scaleMEAN
SECONDARYChange in Aberrant BehaviorFrom Randomization at Baseline until Endpoint at Week 8 (Change over 8 weeks)Data was unable to be collected from 2 participants in the matched Placebo study arm who withdrew from the study.score on a scaleMEAN
SECONDARYChange in Salivary Oxytocin ConcentrationFrom Baseline until collections at 1 hour (Day 1), Week 4 and Week 8
Due to challenges in collecting saliva samples from this population, participants were not able to provide enough saliva to allow for appropriate analysis. As such, samples were not obtained and data was unable to be collected.
SECONDARYClinical Global Impression Scale - Improvement (CGI-I)8 weeks (measuring change over 8 weeks)Data was unable to be collected from 2 participants in the matched Placebo study arm who withdrew from the study.score on a scaleMEAN

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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