CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Syntocinon (Oxytocin) +1 moredrug
Likely dose
Syntocinon (Oxytocin) 24IUfrom 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/NCT02940574
NCT02940574Phase 4Completed

Oxytocin-based Pharmacotherapy for Autism Spectrum Disorders: Investigating the Neural and Behavioral Effects of a Promising Intervention Approach

KU Leuven·interventional·Posted Oct 21, 2016·Updated Feb 10, 2021

In Brief

A Phase 4 clinical trial evaluating Syntocinon (Oxytocin) and Placebo (Physiological water (solution of sodium chloride (NaCl) in water)) for Autism Spectrum Disorders. Completed, enrolled 40 participants.

Detailed Summary

The current trial aims to explore the neural and behavioral effects of oxytocin in autism spectrum disorders (ASD). Oxytocin is a nonapeptide produced by the paraventricular and supraoptic nuclei of the hypothalamus and is known to play a pivotal role in a variety of complex social behaviors. Initial studies showed that intranasal administration of oxytocin can have a positive effect on social functioning in ASD. However, future studies are necessary to explore whether and how oxytocin effects neural processes in the brain underlying these behavioral improvements. This trial will not only measure behavioral enhancements, but will specifically focus on elucidating the associated neurophysiological changes by guiding the administration of oxytocin with regular neurophysiological assessments.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 21, 2016
Enrollment StartApr 1, 2015
Primary CompletionDec 1, 2016
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.7 years ago

Interventions

Syntocinon (Oxytocin)drug

Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray

Placebo (Physiological water (solution of sodium chloride (NaCl) in water))other

Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray