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Hormone Therapy

Oxytocin for Irritability

Phase 1 & 2
Waitlist Available
Led By Soonjo Hwang, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
14-18 years of age
current diagnosis of ADHD, ODD, CD, or DMDD as determined by the Kiddie-SADS, lifetime version;54
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 50 minutes and 2 hours
Awards & highlights

Study Summary

This trial will test whether oxytocin can help reduce irritability in adolescents. 80 subjects will be enrolled over 3 years.

Who is the study for?
This trial is for youths aged 14-18 with ADHD, ODD, CD, or DMDD and significant irritability. They must have stable treatment if on medication and no intelligence scores below 70. Participants cannot have metal in their body that would affect MRI scans, a history of substance abuse or certain mental health disorders, major medical illnesses affecting oxytocin use, allergies to oxytocin products, or CNS diseases.Check my eligibility
What is being tested?
The study tests the effect of different doses (8IU to 80IU) of intranasal oxytocin spray on brain function related to irritability in adolescents using fMRI imaging. It's randomized and double-blind meaning neither researchers nor participants know who gets what dose; some get a placebo.See study design
What are the potential side effects?
While not specified here, common side effects of intranasal oxytocin may include temporary discomfort at the site of administration like nasal irritation or runny nose. Since it's a hormone involved in many bodily functions, there could be other systemic effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 14 and 18 years old.
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I have been diagnosed with ADHD, ODD, CD, or DMDD.
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My current medication has been stable for the required time.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~50 minutes and 2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 50 minutes and 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood Oxygen Level Dependent (BOLD) response within rostro-medial prefrontal cortex ( rmPFC) region of interest to emotional stimuli during the Affective Stroop (AS) at approximately 50 minutes after intranasal administration of OXT.
Plasma
Secondary outcome measures
BOLD responses within peri-aqueductal gray (PAG) and amygdala regions of interest (ROIs) to emotional stimuli during the facial expression task (at approximately 70 minutes) after intranasal administration of OXT.
BOLD responses within the amygdala region of interest (ROI) to emotional stimuli during the Affective Stroop (AS) task (at approximately 50 minutes after intranasal administration of OXT (placebo, 8, 24, 48, and 80 IU).
Saliva level of OXT at 10, 20, 30, 40 and 50 minutes post-administration of intranasal OXT, and immediately after fMRI scanning to calculate area under curve (AUC)
+1 more

Trial Design

5Treatment groups
Active Control
Placebo Group
Group I: Oxytocin Intranasal Spray 8 International Unit (IU)Active Control2 Interventions
Nasal spray of Oxytocin 8 International Unit (8IU) liquid solution as a single dose. fMRI scan pre and post administration.
Group II: Oxytocin Intranasal Spray 24 International Unit (IU)Active Control2 Interventions
Nasal spray of Oxytocin 24 International Unit (24IU) liquid solution as a single dose. fMRI scan pre and post administration.
Group III: Oxytocin Intranasal Spray 48 International Unit (IU)Active Control2 Interventions
Nasal spray of Oxytocin 48 International Unit (48IU) liquid solution as a single dose. fMRI scan pre and post administration.
Group IV: Oxytocin Intranasal Spray 80 International Unit (IU)Active Control2 Interventions
Nasal spray of Oxytocin 80 International Unit (80IU) liquid solution as a single dose. fMRI scan pre and post-administration.
Group V: Intranasal Spray PlaceboPlacebo Group2 Interventions
Nasal spray of placebo liquid solution as a single dose. fMRI scan pre and post-administration.

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,774 Previous Clinical Trials
2,674,243 Total Patients Enrolled
3 Trials studying Irritability
351 Patients Enrolled for Irritability
University of NebraskaLead Sponsor
533 Previous Clinical Trials
1,143,811 Total Patients Enrolled
Soonjo Hwang, MDPrincipal InvestigatorUniversity of Nebraska
1 Previous Clinical Trials
58 Total Patients Enrolled

Media Library

Oxytocin Intranasal Spray (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03863288 — Phase 1 & 2
Irritability Research Study Groups: Intranasal Spray Placebo, Oxytocin Intranasal Spray 8 International Unit (IU), Oxytocin Intranasal Spray 24 International Unit (IU), Oxytocin Intranasal Spray 48 International Unit (IU), Oxytocin Intranasal Spray 80 International Unit (IU)
Irritability Clinical Trial 2023: Oxytocin Intranasal Spray Highlights & Side Effects. Trial Name: NCT03863288 — Phase 1 & 2
Oxytocin Intranasal Spray (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03863288 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has recruitment for this experiment commenced?

"As confirmed by information on clinicaltrials.gov, the medical trial began recruiting patients in February of 2022 and was recently amended 22 July."

Answered by AI

What are the main aims of this clinical investigation?

"This experiment will evaluate the regional brain activity changes to emotional stimuli following intranasal OXT administration. The primary outcome is BOLD response within rmPFC region of interest at approximately 50 minutes post-administration, whereas secondary objectives include Neural changes observable on fMRI in PAG and amygdala regions as well as salivary level of OXT concentration and AUC (Area under curve)."

Answered by AI

How many participants are accepted for this experiment?

"Affirmative. Clinicaltrials.gov reveals that this research is currently canvassing for patients, with the first posting taking place on February 18th 2022 and most recent refresh happening July 22nd 2022. The project requires 80 participants across a single site."

Answered by AI

Are geriatric patients excluded from this experiment?

"This trial is designed for adolescents aged 14 to 18, within which there are 16 other clinical trials. Additionally, 31 studies have been developed specifically with the elderly population of over 65 in mind."

Answered by AI

May I join this medical experiment?

"To qualify for inclusion in this trial, candidates must be displaying signs of irritability and between the ages of 14-18. The desired participant count is 80 individuals."

Answered by AI

What conditions has Oxytocin Intranasal Spray 48IU been proven to alleviate?

"Oxytocin Intranasal Spray 48IU is commonly prescribed to address postpartum bleeding, as well as labor induction and uterine contractions."

Answered by AI
Recent research and studies
~19 spots leftby Mar 2025