Translating Neuroprediction Into Precision Medicine Via Brain Priming

NCT03370510 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 2000021581
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Social Responsiveness Scale, 2nd Edition (SRS-2)

  The SRS-2 is a 65-item measure of social responsiveness. The SRS-2 is filled out by a parent. The SRS-2 has a minimum raw score of 0 and a maximum raw score of 195. Higher raw scores on the SRS-2 mean a worse outcome.

  Change from Baseline to post-treatment, 16 weeks

Secondary Outcomes (1)

• Vineland Adaptive Behavior Scale, 3rd Edition (Vineland-III)

  Change from Baseline to post-treatment, 16 weeks

Other Outcomes (11)

• Gaze Patterns

  Change from Baseline to post-treatment, 16 weeks

• Autism Diagnostic Observation Schedule - 2nd Edition (ADOS-2)

  Change from Baseline to post-treatment, 16 weeks

• Clinical Global Impressions - Severity (CGI-S)

  Change from Baseline to post-treatment, 16 weeks

Study Arms (2)

Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray

EXPERIMENTAL

Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.

Drug: Oxytocin; Behavioral: Pivotal Response Treatment

Pivotal Response Treatment (PRT)/placebo nasal spray

PLACEBO COMPARATOR

Participants will receive a placebo nasal spray 45 minutes prior to each PRT session.

Behavioral: Pivotal Response Treatment; Drug: Placebo

Interventions

Oxytocin DRUG

Oxytocin nasal spray.

Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray

Pivotal Response Treatment BEHAVIORAL

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

Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray; Pivotal Response Treatment (PRT)/placebo nasal spray

Placebo DRUG

Placebo nasal spray.

Pivotal Response Treatment (PRT)/placebo nasal spray

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Fit the age requirement: age 5-9
• Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team
• Be in good medical health
• Be cooperative with testing
• Speak English in the family
• Successfully complete an fMRI scan
• Full-scale intelligence quotient (IQ)\>70

You may not qualify if:

• Any metal or electromagnetic implants, including:
• Cardiac pacemaker
• Defibrillator
• Artificial heart valve
• Aneurysm clip
• Cochlear implants
• Shrapnel
• Neurostimulators
• History of metal fragments in eyes or skin
• Significant hearing loss or other severe sensory impairment
• A fragile health status.
• Current use of prescription psychotropic medications that may affect cognitive processes under study.
• A history of significant head trauma or serious brain or psychiatric illness

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

This study was terminated early due to issues related to the covid-19 pandemic. Only 3 participants completed the trial- 1 out of 3 in the oxytocin group and 2 in the placebo group. As such, the mean score for the oxytocin group is based off of one subjects data only.

Results Point of Contact

• Title: Dr. Pamela Ventola
• Organization: Yale Child Study Center

ventolalab@yale.edu

(203) 737-4378

Study Officials

• Denis Sukhodolsky, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eighty children will be randomly assigned to receive PRT with either oxytocin (forty children) or a placebo (forty children).

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 12, 2017
• Study Start: December 7, 2018
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: August 9, 2022
• Results First Posted: August 9, 2022

Record last verified: 2022-08

Locations

US (1)