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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 is a Phase 1 study that was terminated before completion, run by University of Nebraska. The registered enrollment target is 60 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03863288
The ClinicalTrials.gov registry entry for NCT03863288 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Functional MRI (fMRI) is the first listed.
NCT03863288 reports 0 study locations.
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.
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