CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Oxytocin +1 moredrug
Likely dose
Oxytocin 32IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01308749
NCT01308749Phase 2Completed
CompareCT.gov

A Pilot Study of Oxytocin in Children and Adolescents With Autistic Disorder

University of North Carolina, Chapel Hill·interventional·Posted Mar 4, 2011·Updated Jul 17, 2017

In Brief

A Phase 2 clinical trial evaluating Oxytocin and Placebo for Autism. Completed, enrolled 25 participants across 1 site.

Detailed Summary

The investigators propose to conduct this pilot study to evaluate oxytocin as a supplemental treatment for improving social difficulties in individuals with autism.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism
CountriesUnited States
CollaboratorsAutism Speaks

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 4, 2011
Enrollment StartMar 1, 2011
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.3 years ago

Interventions

Oxytocindrug

Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase. Subjects ages 3-10 years old will be titrated up to a maximum dose of 24 International units (IU). Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU.

Placebodrug

Placebo Nasal Spray