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Trial · Interventional

TerminatedPhase 1/2Registry data

Dose Response Relationship of Oxytocin on Irritability in Youths

NCTNCT03863288 (opens ClinicalTrials.gov in a new tab)Other id0219-20-FBOther id1U01MH120155-01A1
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Overview

Status
Terminated
Phase
Phase 1/2
Enrollment
60 participants (actual)
Sponsor
University of Nebraska · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
18 Feb 2022
Primary completion
27 Feb 2024
Completion
27 Feb 2024
First posted
5 Mar 2019
Last update posted
14 Mar 2025
Conditions
Irritable Mood

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 1/2

    Dose Response Relationship of Oxytocin on Irritability in Youths

    NCT03863288

    18 Feb 2022 to 27 Feb 2024

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • 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
  • PlaceboDrug

Arms5

  • Placebo comparator

    Intranasal Spray Placebo

    Nasal spray of placebo liquid solution as a single dose. fMRI scan pre and post-administration.

  • Active comparator

    Oxytocin Intranasal Spray 8 International Unit (IU)

    Nasal spray of Oxytocin 8 International Unit (8IU) liquid solution as a single dose. fMRI scan pre and post administration.

  • Active comparator

    Oxytocin Intranasal Spray 24 International Unit (IU)

    Nasal spray of Oxytocin 24 International Unit (24IU) liquid solution as a single dose. fMRI scan pre and post administration.

  • Active comparator

    Oxytocin Intranasal Spray 48 International Unit (IU)

    Nasal spray of Oxytocin 48 International Unit (48IU) liquid solution as a single dose. fMRI scan pre and post administration.

  • Active comparator

    Oxytocin Intranasal Spray 80 International Unit (IU)

    Nasal spray of Oxytocin 80 International Unit (80IU) liquid solution as a single dose. fMRI scan pre and post-administration.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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.

  2. 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

    Registry description

    Area under the curve (OXT dose response)

Secondary outcomes(4)

  1. 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

    Registry description

    Neural changes observable on fMRI as BOLD responses in amygdala.

  2. The degree of functional connectivity between rmPFC and amygdala during resting-state fMRI (rs-fMRI) after intranasal administration of OXT.

    Time frame · 60 minutes

    Registry description

    functional connectivity observable on rs-fMRI

  3. 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

    Registry description

    Neural changes observable on fMRI as BOLD responses in PAG and amygdala.

  4. 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

    Registry description

    Area under curve (OXT dose response)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies15

Studies that cite this trial.

Studies with results

8 studies on this page

Indexing hint: Randomized controlled trial · 2019

4 results

A dose-finding study of oxytocin using neurophysiological measures of social processing.

Wynn et al. 2019Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacologycited by 34

PMID 30082892PMC6300532DOI 10.1038/s41386-018-0165-yPUB-30082892

Rights unknown4 results
Source linkSee results (4)

Indexing hint: Meta-analysis (pooled) · 2018

4 results

Meta-analytic review of the effects of a single dose of intranasal oxytocin on threat processing in humans.

Leppanen et al. 2018Journal of affective disorderscited by 40

PMID 28837950DOI 10.1016/j.jad.2017.08.041PUB-28837950

Rights unknown4 results
Source linkSee results (4)

Indexing hint: Meta-analysis (pooled) · 2018

1 result

Oxytocin and brain activity in humans: A systematic review and coordinate-based meta-analysis of functional MRI studies.

Grace et al. 2018Psychoneuroendocrinologycited by 103

PMID 29879563DOI 10.1016/j.psyneuen.2018.05.031PUB-29879563

Full text at the publisher1 result
Publisher pageSee results (1)

Indexing hint: Randomized controlled trial · 2017

6 results

Oxytocin differentially alters resting state functional connectivity between amygdala subregions and emotional control networks: Inverse correlation with depressive traits.

Eckstein et al. 2017NeuroImagecited by 62

PMID 28161309DOI 10.1016/j.neuroimage.2017.01.078PUB-28161309

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 2017

3 results

Kinetics and Dose Dependency of Intranasal Oxytocin Effects on Amygdala Reactivity.

Spengler et al. 2017Biological psychiatrycited by 206

PMID 28629540DOI 10.1016/j.biopsych.2017.04.015PUB-28629540

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Observational study · 2017

2 results

A comparison of methods to measure central and peripheral oxytocin concentrations in human and non-human primates.

Lefevre et al. 2017Scientific reportscited by 85

PMID 29222505PMC5722864DOI 10.1038/s41598-017-17674-7PUB-29222505

CC BY2 results
Download PDFSee results (2)

Indexing hint: Randomized controlled trial · 2016

3 results

Intranasal Oxytocin Administration Dampens Amygdala Reactivity towards Emotional Faces in Male and Female PTSD Patients.

Koch et al. 2016Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacologycited by 84

PMID 26404844PMC4832009DOI 10.1038/npp.2015.299PUB-26404844

Rights unknown3 results
Source linkSee results (3)

Indexing hint: Randomized controlled trial · 2013

5 results

Elevated cerebrospinal fluid and blood concentrations of oxytocin following its intranasal administration in humans.

Striepens et al. 2013Scientific reportscited by 366

PMID 24310737PMC3853684DOI 10.1038/srep03440PUB-24310737

Free to read · publisher termsCC BY-NC-ND5 results
Read at sourceSee results (5)

More studies

7 studies on this page

Indexing hint: Animal study · 2018

Oxytocin by intranasal and intravenous routes reaches the cerebrospinal fluid in rhesus macaques: determination using a novel oxytocin assay.

Lee et al. 2018Molecular psychiatrycited by 200

PMID 28289281PMC5862033DOI 10.1038/mp.2017.27PUB-28289281

Rights unknown
Source link

Indexing hint: Review · 2018

Overview of Human Oxytocin Research.

Kendrick et al. 2018Current topics in behavioral neurosciencescited by 82

PMID 28864976DOI 10.1007/7854_2017_19PUB-28864976

Full text at the publisher
Publisher page

Indexing hint: Animal study · 2018

High-yielding 18F radiosynthesis of a novel oxytocin receptor tracer, a probe for nose-to-brain oxytocin uptake in vivo.

Beard et al. 2018Chemical communications (Cambridge, England)cited by 25

PMID 29974895PMC6049614DOI 10.1039/c8cc01400kPUB-29974895

CC BY
Download PDF

PubMed tag: none · 2016

Translating Oxytocin Neuroscience to the Clinic: A National Institute of Mental Health Perspective.

Insel et al. 2016Biological psychiatrycited by 50

PMID 26723108DOI 10.1016/j.biopsych.2015.02.002PUB-26723108

Full text at the publisher
Publisher page

Indexing hint: Review · 2013

The role of oxytocin in psychiatric disorders: a review of biological and therapeutic research findings.

Cochran et al. 2013Harvard review of psychiatrycited by 202

PMID 24651556PMC4120070DOI 10.1097/hrp.0b013e3182a75b7dPUB-24651556

Rights unknown
Source link

Indexing hint: Review · 2012

Acute effects of steroid hormones and neuropeptides on human social-emotional behavior: a review of single administration studies.

Bos et al. 2012Frontiers in neuroendocrinologycited by 288

PMID 21256859DOI 10.1016/j.yfrne.2011.01.002PUB-21256859

Full text at the publisher
Publisher page

Indexing hint: Review · 2011

Potential for oxytocin use in children and adolescents with mental illness.

Netherton et al. 2011Human psychopharmacologycited by 13

PMID 21751251DOI 10.1002/hup.1212PUB-21751251

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 14 Years up to 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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