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NCT03863288 · ClinicalTrials.gov registry record · Phase 1
Dose Response Relationship of Oxytocin on Irritability in Youths
A Phase 1 study, sponsored by University of Nebraska.
- Terminated
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT03863288: Clinical Trial Phase 1 study, sponsored by University of Nebraska.
NCT03863288 is a Phase 1 study that was terminated before completion, run by University of Nebraska. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03863288, a Phase 1 study, was terminated before completion, sponsored by University of Nebraska.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The proposed study is a randomized, double-blind proof of concept (PoC) study on the neural impact of intranasal oxytocin (OXT) administration for adolescents (age 14 to 18), demonstrating a clinically significant level of irritability as defined by a score of ≥4 on the Affective Reactivity Index (ARI). Planned enrollment is 80 subjects over 3 years.
Primary Outcome
Neural changes observable on fMRI as BOLD responses in medial prefrontal cortex. Response data will be generated for each participant for the four OXT doses (8, 24, 48 and 80 IU) and placebo.
Interventions
- PROCEDURE Functional MRI (fMRI)
- DRUG Oxytocin Intranasal Spray 8 International Unit (8IU)
- DRUG Oxytocin intranasal spray 24 International Unit (24IU)
- DRUG Oxytocin intranasal spray 48 International Unit (48IU)
- DRUG Oxytocin intranasal spray 80 International Unit (80IU)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-02-18 |
| Est. Completion | 2024-02-27 |
| Phase | Phase 1 |
Why NCT03863288 stopped before completion
NCT03863288 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Functional MRI (fMRI) is the first listed.
NCT03863288 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03863288 about?
NCT03863288 is a clinical study titled "Dose Response Relationship of Oxytocin on Irritability in Youths". The proposed study is a randomized, double-blind proof of concept (PoC) study on the neural impact of intranasal oxytocin (OXT) administration for adolescents (age 14 to 18), demonstrating a clinically significant level of irritability as defined by a score of ≥4 on the Affective Reactivity Index (A...
What is the current status of trial NCT03863288?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2022-02-18. Estimated completion is 2024-02-27.
What interventions are being tested in trial NCT03863288?
The interventions under investigation include: Functional MRI (fMRI) (PROCEDURE), Oxytocin Intranasal Spray 8 International Unit (8IU) (DRUG), Oxytocin intranasal spray 24 International Unit (24IU) (DRUG), Oxytocin intranasal spray 48 International Unit (48IU) (DRUG), Oxytocin intranasal spray 80 International Unit (80IU) (DRUG).
Who is sponsoring clinical trial NCT03863288?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03863288's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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