Irritable MoodPhase 1/2NCT03863288
Dose Response Relationship of Oxytocin on Irritability in Youths
A Phase 1/2 study testing Functional MRI (fMRI), Oxytocin Intranasal Spray 8 International Unit (8IU) and Oxytocin intranasal spray 24 International Unit (24IU) in people with Irritable Mood, run by University of Nebraska at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Irritable Mood
- What is being tested?
- Functional MRI (fMRI), Oxytocin Intranasal Spray 8 International Unit (8IU) and Oxytocin intranasal spray 24 International Unit (24IU)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2022to 27 Feb 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 14-18 years of age
- current diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), or Disruptive Mood Dysregulation Disorder (DMDD) as determined by the Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS), lifetime version;54
- Clinically significant level of irritability as defined by a score of ≥4 on the Affective Reactivity Index (ARI)
- If currently on medication, treatment must be stable for at least 2 weeks with stimulant medication, and at least 4 weeks with alpha 2 agonist, atomoxetine, antipsychotics, mood stabilizers, or antidepressant.
Who cannot join
- Comorbid psychotic, tic, autism spectrum disorder, or substance use disorders, or current diagnosis of bipolar disorder; -Major medical illness that prohibits OXT administration (e.g., severe liver disease, seizure disorder, metabolic disorder)
- Past history of allergic reaction to OXT and its intranasal product
- History of Central Nervous System (CNS) disease (including history of seizure, epilepsy, CNS tumor, CNS hemorrhage, or serious CNS infection including meningitis or encephalitis)
- A positive urine pregnancy test
- A positive urine drug screen or currently active diagnosis of substance use disorder
- Wechsler Abbreviated Scale of Intelligence (WASI-2; two subset form) scores <70
- Metal in the body (i.e., hearing aid, cardiac pacemaker, bone plates, braces, non-removable piercing/implants, etc.), claustrophobia, or any other condition that would preclude MRI scanning.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, Department of Psychiatry
Omaha, Nebraska, 61898-5581
About this study
Official title: Dose-Response Relationship and Pharmacokinetics of Intranasal Oxytocin on Neural Impact in Youth With High Levels of Irritability
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.
Read the detailed description
Endogenous oxytocin (OXT) has been a focus of prior psychiatric research due to its role in pro-social behavior, and modulation of response to social/emotional stimuli. Although many studies argue that the intranasal administration of OXT can produce behavioral as well as neural changes, there is surprisingly little comprehensive research on this issue. Most of the previous studies are limited by using a single dose of intranasal OXT in small samples, and there is no current consensus regarding appropriate dosage and very little data on neural impact as a function of dose. There has been little consideration of the relation between pharmacokinetics (peripheral level of OXT after administration) and the degree of induced neural changes. None of these issues have been studied in a pediatric population with clinically significant psychopathology. This study is proposed to determine the extent to which neural changes are induced by OXT intranasal administration, by examining the dose-response relationship (the degree of neural changes induced by various doses of OXT) and the correlation of pharmacokinetics (peripheral level of OXT after administration and the induced neural changes) in youths with clinically significant psychopathology. The form of psychopathology targeted is irritability: the increased propensity to exhibit anger relative to peers.One of the neurobiological mechanisms of irritability implicates dysfunction in the acute threat response system. OXT, with its most commonly proposed mechanism being reduction of hyperactivity in the acute threat response system, is a potentially promising agent to induce neural changes in the target brain areas of the acute threat response system for youths with high levels of irritability. The study aims to quantify the extent to which different doses of OXT will reduce the activation of the acute threat response system to emotional stimuli in youths with high levels of irritability. Both resting state and task-based functional MRI will be used , using affective-cognitive tasks (to obtain the primary aim will begin after the clinician scan) with demonstrated test-retest reliability and capability of capturing the core target areas of OXT administration in the acute threat response system. Pharmacokinetics (plasma and saliva level) after OXT administration will be examined to determine correlation with the induced neural changes in the target areas.
- Conditions
- Irritable Mood
- Being tested
- Functional MRI (fMRI), Oxytocin Intranasal Spray 8 International Unit (8IU), Oxytocin intranasal spray 24 International Unit (24IU), Oxytocin intranasal spray 48 International Unit (48IU), Oxytocin intranasal spray 80 International Unit (80IU)
- Keywords
- oxytocin, neuroimaging, irritability, fMRI, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional MRI (fMRI)Procedure or surgery
Functional MRI (fMRI) scan with affective/cognitive tasks
Oxytocin Intranasal Spray 8 International Unit (8IU)Drug
Oxytocin intranasal spray liquid administration
Oxytocin intranasal spray 24 International Unit (24IU)Drug
Oxytocin intranasal spray liquid administration
Oxytocin intranasal spray 48 International Unit (48IU)Drug
Oxytocin intranasal spray liquid administration
Oxytocin intranasal spray 80 International Unit (80IU)Drug
Oxytocin intranasal spray liquid administration
PlaceboDrug
Placebo intranasal spray liquid administration
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Spray Placebo | Placebo comparator | Nasal spray of placebo liquid solution as a single dose. fMRI scan pre and post-administration. Receives: Procedure: Functional MRI (fMRI); Drug: Placebo |
| Oxytocin Intranasal Spray 8 International Unit (IU) | Active comparator | Nasal spray of Oxytocin 8 International Unit (8IU) liquid solution as a single dose. fMRI scan pre and post administration. Receives: Procedure: Functional MRI (fMRI); Drug: Oxytocin Intranasal Spray 8 International Unit (8IU) |
| Oxytocin Intranasal Spray 24 International Unit (IU) | Active comparator | Nasal spray of Oxytocin 24 International Unit (24IU) liquid solution as a single dose. fMRI scan pre and post administration. Receives: Procedure: Functional MRI (fMRI); Drug: Oxytocin intranasal spray 24 International Unit (24IU) |
| Oxytocin Intranasal Spray 48 International Unit (IU) | Active comparator | Nasal spray of Oxytocin 48 International Unit (48IU) liquid solution as a single dose. fMRI scan pre and post administration. Receives: Procedure: Functional MRI (fMRI); Drug: Oxytocin intranasal spray 48 International Unit (48IU) |
| Oxytocin Intranasal Spray 80 International Unit (IU) | Active comparator | Nasal spray of Oxytocin 80 International Unit (80IU) liquid solution as a single dose. fMRI scan pre and post-administration. Receives: Procedure: Functional MRI (fMRI); Drug: Oxytocin intranasal spray 80 International Unit (80IU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 50 minutes
Plasma concentrations of OXT at 10, 20, 30, 40, and 50 minutes post intranasal OXT administration, and immediately post-fMRI scanning.
Area under the curve (OXT dose response)
Measured: 50 minutes and 2 hours
Secondary outcomes (4)
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).
Neural changes observable on fMRI as BOLD responses in amygdala.
Measured: 50 minutes
The degree of functional connectivity between rmPFC and amygdala during resting-state fMRI (rs-fMRI) after intranasal administration of OXT.
functional connectivity observable on rs-fMRI
Measured: 60 minutes
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.
Neural changes observable on fMRI as BOLD responses in PAG and amygdala.
Measured: 70 minutes
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)
Area under curve (OXT dose response)
Measured: 50 minutes and 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start18 Feb 2022
- Primary completion27 Feb 2024
- Study completion27 Feb 2024
Why it stopped: Per DSMB's recommendation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Irritable MoodStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Soonjo Hwang, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863288
- Sponsor's protocol ID
- 0219-20-FB
- Other IDs
- 1U01MH120155-01A1
- Status last verified
- Mar 2025
- First submitted
- 25 Sep 2018
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee MR, Scheidweiler KB, Diao XX, Akhlaghi F, Cummins A, Huestis MA, Leggio L, Averbeck BB. Oxytocin by intranasal and intravenous routes reaches the cerebrospinal fluid in rhesus macaques: determination using a novel oxytocin assay. Mol Psychiatry. 2018 Jan;23(1):115-122. doi: 10.1038/mp.2017.27. Epub 2017 Mar 14.
PubMed 28289281Beard R , Singh N , Grundschober C , Gee AD , Tate EW . High-yielding 18F radiosynthesis of a novel oxytocin receptor tracer, a probe for nose-to-brain oxytocin uptake in vivo. Chem Commun (Camb). 2018 Jul 17;54(58):8120-8123. doi: 10.1039/c8cc01400k.
PubMed 29974895Cochran DM, Fallon D, Hill M, Frazier JA. The role of oxytocin in psychiatric disorders: a review of biological and therapeutic research findings. Harv Rev Psychiatry. 2013 Sep-Oct;21(5):219-47. doi: 10.1097/HRP.0b013e3182a75b7d.
PubMed 24651556Kendrick KM, Guastella AJ, Becker B. Overview of Human Oxytocin Research. Curr Top Behav Neurosci. 2018;35:321-348. doi: 10.1007/7854_2017_19.
PubMed 28864976Bos PA, Panksepp J, Bluthe RM, van Honk J. Acute effects of steroid hormones and neuropeptides on human social-emotional behavior: a review of single administration studies. Front Neuroendocrinol. 2012 Jan;33(1):17-35. doi: 10.1016/j.yfrne.2011.01.002. Epub 2011 Jan 21.
PubMed 21256859Insel TR. Translating Oxytocin Neuroscience to the Clinic: A National Institute of Mental Health Perspective. Biol Psychiatry. 2016 Feb 1;79(3):153-4. doi: 10.1016/j.biopsych.2015.02.002. Epub 2015 Nov 16. No abstract available.
PubMed 26723108Spengler FB, Schultz J, Scheele D, Essel M, Maier W, Heinrichs M, Hurlemann R. Kinetics and Dose Dependency of Intranasal Oxytocin Effects on Amygdala Reactivity. Biol Psychiatry. 2017 Dec 15;82(12):885-894. doi: 10.1016/j.biopsych.2017.04.015. Epub 2017 May 10.
PubMed 28629540Striepens N, Kendrick KM, Hanking V, Landgraf R, Wullner U, Maier W, Hurlemann R. Elevated cerebrospinal fluid and blood concentrations of oxytocin following its intranasal administration in humans. Sci Rep. 2013 Dec 6;3:3440. doi: 10.1038/srep03440.
PubMed 24310737Netherton E, Schatte D. Potential for oxytocin use in children and adolescents with mental illness. Hum Psychopharmacol. 2011 Jun-Jul;26(4-5):271-81. doi: 10.1002/hup.1212. Epub 2011 Jul 12.
PubMed 21751251Leibenluft E. Pediatric Irritability: A Systems Neuroscience Approach. Trends Cogn Sci. 2017 Apr;21(4):277-289. doi: 10.1016/j.tics.2017.02.002. Epub 2017 Mar 6.
PubMed 28274677Blair RJR. Traits of empathy and anger: implications for psychopathy and other disorders associated with aggression. Philos Trans R Soc Lond B Biol Sci. 2018 Apr 19;373(1744):20170155. doi: 10.1098/rstb.2017.0155.
PubMed 29483341Grace SA, Rossell SL, Heinrichs M, Kordsachia C, Labuschagne I. Oxytocin and brain activity in humans: A systematic review and coordinate-based meta-analysis of functional MRI studies. Psychoneuroendocrinology. 2018 Oct;96:6-24. doi: 10.1016/j.psyneuen.2018.05.031. Epub 2018 May 24.
PubMed 29879563Leibenluft E, Stoddard J. The developmental psychopathology of irritability. Dev Psychopathol. 2013 Nov;25(4 Pt 2):1473-87. doi: 10.1017/S0954579413000722.
PubMed 24342851Wiggins JL, Brotman MA, Adleman NE, Kim P, Oakes AH, Reynolds RC, Chen G, Pine DS, Leibenluft E. Neural Correlates of Irritability in Disruptive Mood Dysregulation and Bipolar Disorders. Am J Psychiatry. 2016 Jul 1;173(7):722-30. doi: 10.1176/appi.ajp.2015.15060833. Epub 2016 Feb 19.
PubMed 26892942Hwang S, Nolan ZT, White SF, Williams WC, Sinclair S, Blair RJ. Dual neurocircuitry dysfunctions in disruptive behavior disorders: emotional responding and response inhibition. Psychol Med. 2016 May;46(7):1485-96. doi: 10.1017/S0033291716000118. Epub 2016 Feb 15.
PubMed 26875722
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Response Relationship and Pharmacokinetics of Intranasal Oxytocin on Neural Impact in Youth With High Levels of Irritability
- ClinicalTrials.gov ID
- NCT03863288
- Acronym / sponsor ID
- 0219-20-FB
- Conditions
- Irritable Mood
- Keywords
- oxytocin, neuroimaging, irritability, fMRI, pharmacokinetics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per DSMB's recommendation
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Endogenous oxytocin (OXT) has been a focus of prior psychiatric research due to its role in pro-social behavior, and modulation of response to social/emotional stimuli. Although many studies argue that the intranasal administration of OXT can produce behavioral as well as neural changes, there is surprisingly little comprehensive research on this issue. Most of the previous studies are limited by using a single dose of intranasal OXT in small samples, and there is no current consensus regarding appropriate dosage and very little data on neural impact as a function of dose. There has been little consideration of the relation between pharmacokinetics (peripheral level of OXT after administration) and the degree of induced neural changes. None of these issues have been studied in a pediatric population with clinically significant psychopathology. This study is proposed to determine the extent to which neural changes are induced by OXT intranasal administration, by examining the dose-response relationship (the degree of neural changes induced by various doses of OXT) and the correlation of pharmacokinetics (peripheral level of OXT after administration and the induced neural changes) in youths with clinically significant psychopathology. The form of psychopathology targeted is irritability: the increased propensity to exhibit anger relative to peers.One of the neurobiological mechanisms of irritability implicates dysfunction in the acute threat response system. OXT, with its most commonly proposed mechanism being reduction of hyperactivity in the acute threat response system, is a potentially promising agent to induce neural changes in the target brain areas of the acute threat response system for youths with high levels of irritability. The study aims to quantify the extent to which different doses of OXT will reduce the activation of the acute threat response system to emotional stimuli in youths with high levels of irritability. Both resting state and task-based functional MRI will be used , using affective-cognitive tasks (to obtain the primary aim will begin after the clinician scan) with demonstrated test-retest reliability and capability of capturing the core target areas of OXT administration in the acute threat response system. Pharmacokinetics (plasma and saliva level) after OXT administration will be examined to determine correlation with the induced neural changes in the target areas.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
- Model description
- Randomized, double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Intranasal Spray Placebo | Placebo comparator | Procedure: Functional MRI (fMRI), Drug: PlaceboNasal spray of placebo liquid solution as a single dose. fMRI scan pre and post-administration. |
| Oxytocin Intranasal Spray 8 International Unit (IU) | Active comparator | Procedure: Functional MRI (fMRI), Drug: Oxytocin Intranasal Spray 8 International Unit (8IU)Nasal spray of Oxytocin 8 International Unit (8IU) liquid solution as a single dose. fMRI scan pre and post administration. |
| Oxytocin Intranasal Spray 24 International Unit (IU) | Active comparator | Procedure: Functional MRI (fMRI), Drug: Oxytocin intranasal spray 24 International Unit (24IU)Nasal spray of Oxytocin 24 International Unit (24IU) liquid solution as a single dose. fMRI scan pre and post administration. |
| Oxytocin Intranasal Spray 48 International Unit (IU) | Active comparator | Procedure: Functional MRI (fMRI), Drug: Oxytocin intranasal spray 48 International Unit (48IU)Nasal spray of Oxytocin 48 International Unit (48IU) liquid solution as a single dose. fMRI scan pre and post administration. |
| Oxytocin Intranasal Spray 80 International Unit (IU) | Active comparator | Procedure: Functional MRI (fMRI), Drug: Oxytocin intranasal spray 80 International Unit (80IU)Nasal spray of Oxytocin 80 International Unit (80IU) liquid solution as a single dose. fMRI scan pre and post-administration. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 14-18 years of age
- current diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), or Disruptive Mood Dysregulation Disorder (DMDD) as determined by the Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS), lifetime version;54
- Clinically significant level of irritability as defined by a score of ≥4 on the Affective Reactivity Index (ARI)
- If currently on medication, treatment must be stable for at least 2 weeks with stimulant medication, and at least 4 weeks with alpha 2 agonist, atomoxetine, antipsychotics, mood stabilizers, or antidepressant.
Key exclusion criteria (7 listed)
- Comorbid psychotic, tic, autism spectrum disorder, or substance use disorders, or current diagnosis of bipolar disorder; -Major medical illness that prohibits OXT administration (e.g., severe liver disease, seizure disorder, metabolic disorder)
- Past history of allergic reaction to OXT and its intranasal product
- History of Central Nervous System (CNS) disease (including history of seizure, epilepsy, CNS tumor, CNS hemorrhage, or serious CNS infection including meningitis or encephalitis)
- A positive urine pregnancy test
- A positive urine drug screen or currently active diagnosis of substance use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional MRI (fMRI)Functional MRI (fMRI) scan with affective/cognitive tasks | Procedure or surgery | Intranasal Spray Placebo, Oxytocin Intranasal Spray 24 International Unit (IU), Oxytocin Intranasal Spray 48 International Unit (IU), Oxytocin Intranasal Spray 8 International Unit (IU), Oxytocin Intranasal Spray 80 International Unit (IU) |
| Oxytocin Intranasal Spray 8 International Unit (8IU)Oxytocin intranasal spray liquid administration | Drug | Oxytocin Intranasal Spray 8 International Unit (IU) |
| Oxytocin intranasal spray 24 International Unit (24IU)Oxytocin intranasal spray liquid administration | Drug | Oxytocin Intranasal Spray 24 International Unit (IU) |
| Oxytocin intranasal spray 48 International Unit (48IU)Oxytocin intranasal spray liquid administration | Drug | Oxytocin Intranasal Spray 48 International Unit (IU) |
| Oxytocin intranasal spray 80 International Unit (80IU)Oxytocin intranasal spray liquid administration | Drug | Oxytocin Intranasal Spray 80 International Unit (IU) |
| PlaceboPlacebo intranasal spray liquid administration | Drug | Intranasal Spray Placebo |
Primary outcome
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.
Time frame: 50 minutes
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.
Plasma concentrations of OXT at 10, 20, 30, 40, and 50 minutes post intranasal OXT administration, and immediately post-fMRI scanning.
Time frame: 50 minutes and 2 hours
Area under the curve (OXT dose response)
4 secondary outcomes
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).
Time frame: 50 minutes
The degree of functional connectivity between rmPFC and amygdala during resting-state fMRI (rs-fMRI) after intranasal administration of OXT.
Time frame: 60 minutes
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.
Time frame: 70 minutes
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)
Time frame: 50 minutes and 2 hours
Results and safety
The study was stopped early (reason given: Per DSMB's recommendation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Background: PubMed 28289281Lee MR, Scheidweiler KB, Diao XX, Akhlaghi F, Cummins A, Huestis MA, Leggio L, Averbeck BB. Oxytocin by intranasal and intravenous routes reaches the cerebrospinal fluid in rhesus macaques: determination using a novel oxytocin assay. Mol Psychiatry. 2018 Jan;23(1):115-122. doi: 10.1038/mp.2017.27. Epub 2017 Mar 14.
- Background: PubMed 29974895Beard R , Singh N , Grundschober C , Gee AD , Tate EW . High-yielding 18F radiosynthesis of a novel oxytocin receptor tracer, a probe for nose-to-brain oxytocin uptake in vivo. Chem Commun (Camb). 2018 Jul 17;54(58):8120-8123. doi: 10.1039/c8cc01400k.
- Background: PubMed 24651556Cochran DM, Fallon D, Hill M, Frazier JA. The role of oxytocin in psychiatric disorders: a review of biological and therapeutic research findings. Harv Rev Psychiatry. 2013 Sep-Oct;21(5):219-47. doi: 10.1097/HRP.0b013e3182a75b7d.
- Background: PubMed 28864976Kendrick KM, Guastella AJ, Becker B. Overview of Human Oxytocin Research. Curr Top Behav Neurosci. 2018;35:321-348. doi: 10.1007/7854_2017_19.
- Background: PubMed 21256859Bos PA, Panksepp J, Bluthe RM, van Honk J. Acute effects of steroid hormones and neuropeptides on human social-emotional behavior: a review of single administration studies. Front Neuroendocrinol. 2012 Jan;33(1):17-35. doi: 10.1016/j.yfrne.2011.01.002. Epub 2011 Jan 21.
- Background: PubMed 26723108Insel TR. Translating Oxytocin Neuroscience to the Clinic: A National Institute of Mental Health Perspective. Biol Psychiatry. 2016 Feb 1;79(3):153-4. doi: 10.1016/j.biopsych.2015.02.002. Epub 2015 Nov 16. No abstract available.
- Background: PubMed 28629540Spengler FB, Schultz J, Scheele D, Essel M, Maier W, Heinrichs M, Hurlemann R. Kinetics and Dose Dependency of Intranasal Oxytocin Effects on Amygdala Reactivity. Biol Psychiatry. 2017 Dec 15;82(12):885-894. doi: 10.1016/j.biopsych.2017.04.015. Epub 2017 May 10.
- Background: PubMed 24310737Striepens N, Kendrick KM, Hanking V, Landgraf R, Wullner U, Maier W, Hurlemann R. Elevated cerebrospinal fluid and blood concentrations of oxytocin following its intranasal administration in humans. Sci Rep. 2013 Dec 6;3:3440. doi: 10.1038/srep03440.
- Background: PubMed 21751251Netherton E, Schatte D. Potential for oxytocin use in children and adolescents with mental illness. Hum Psychopharmacol. 2011 Jun-Jul;26(4-5):271-81. doi: 10.1002/hup.1212. Epub 2011 Jul 12.
- Background: PubMed 28274677Leibenluft E. Pediatric Irritability: A Systems Neuroscience Approach. Trends Cogn Sci. 2017 Apr;21(4):277-289. doi: 10.1016/j.tics.2017.02.002. Epub 2017 Mar 6.
- Background: PubMed 29483341Blair RJR. Traits of empathy and anger: implications for psychopathy and other disorders associated with aggression. Philos Trans R Soc Lond B Biol Sci. 2018 Apr 19;373(1744):20170155. doi: 10.1098/rstb.2017.0155.
- Background: PubMed 29879563Grace SA, Rossell SL, Heinrichs M, Kordsachia C, Labuschagne I. Oxytocin and brain activity in humans: A systematic review and coordinate-based meta-analysis of functional MRI studies. Psychoneuroendocrinology. 2018 Oct;96:6-24. doi: 10.1016/j.psyneuen.2018.05.031. Epub 2018 May 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soonjo Hwang, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Functional MRI (fMRI), Oxytocin Intranasal Spray 8 International Unit (8IU) and Oxytocin intranasal spray 24 International Unit (24IU) in people with Irritable Mood, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Per DSMB's recommendation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 50 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03863288, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.