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NCT03370510 · ClinicalTrials.gov registry record · Phase 2
Translating Neuroprediction Into Precision Medicine Via Brain Priming
A Phase 2 study, sponsored by Yale University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT03370510: Clinical Trial Phase 2 study, sponsored by Yale University.
NCT03370510 is a Phase 2 study that was terminated before completion, run by Yale University. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03370510, a Phase 2 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Oxytocin
- BEHAVIORAL Pivotal Response Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-12-07 |
| Est. Completion | 2021-07-28 |
| Phase | Phase 2 |
Why NCT03370510 stopped before completion
NCT03370510 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03370510 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03370510 about?
NCT03370510 is a clinical study titled "Translating Neuroprediction Into Precision Medicine Via Brain Priming". 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. Par...
What is the current status of trial NCT03370510?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2018-12-07. Estimated completion is 2021-07-28.
What interventions are being tested in trial NCT03370510?
The interventions under investigation include: Placebo (DRUG), Oxytocin (DRUG), Pivotal Response Treatment (BEHAVIORAL).
Who is sponsoring clinical trial NCT03370510?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03370510's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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