MedTrace Logo

Translating Neuroprediction Into Precision Medicine Via Brain Priming

NCT03370510 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-08-09

Study results available
· View outcomes & findings →

Summary

The present study examines the impact of oxytocin (OXT) and Pivotal Response Treatment (PRT) on the development of language, social, and play skills in young children with Autism Spectrum Disorder (ASD). The purpose of this study is to examine the impact of OXT as an enhancer of response to PRT. Participants will be randomly assigned to either an intranasal OXT group or a placebo group. Neither the research team nor the participants will know or choose which group the participant is assigned to. Children in both groups will participate in a 16-week trial of PRT. The trial will test the hypothesis that children with lower levels of activity in and functional connectivity among certain PRT-response brain regions will benefit more from the administration of OXT vs. placebo as an enhancer to a 16-week trial of PRT.

Conditions

Interventions

DRUG

Oxytocin

Oxytocin nasal spray.

BEHAVIORAL

Pivotal Response Treatment

An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.

DRUG

Placebo

Placebo nasal spray.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Denis Sukhodolsky, Ph.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-07
Primary Completion
2021-07-28
Completion
2021-07-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03370510 on ClinicalTrials.gov