Skip to content

Trial · Interventional

CompletedPhase 1Results postedRegistry data

Brain Dynamics of Oxytocin

NCTNCT01834261 (opens ClinicalTrials.gov in a new tab)Other id293408Other idN000141210393

Overview

Status
Completed
Phase
Phase 1
Enrollment
51 participants (actual)
Sponsor
Stony Brook University · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Apr 2013
Primary completion
May 2015
Completion
May 2015
First posted
17 Apr 2013 (estimated)
Last update posted
17 Mar 2017
Conditions
Brain Dynamics in Healthy Adults

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 1

    Brain Dynamics of Oxytocin

    NCT01834261

    Apr 2013 to May 2015

Registry summary

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

Oxytocin is a neuropeptide that is well known for its role in social and affiliative behavior in humans. Oxytocin receptors are significantly lowered in autistic individuals and administration of oxytocin has shown benefits in enhancing social recognition and behavior in autistic children. However, more recent research has refined the behavioral effects of oxytocin, moving away from the notion that the neuropeptide blindly induces love and trust, towards the view that it actually increases social perception in assessing friend vs. foe: supporting cohesion with 'insiders' and distrust and aggression for 'outsiders.' Oxytocin is responsible for the selective aggression shown by lactating female mammals protecting their young, an effect demonstrated also in humans, and has been shown to strengthen feelings of ethnocentrism. However, no neuroimaging study to date has investigated this effect, with the consequence that its neurobiological basis is still unknown. The general aim of our study is to determine meso-circuit brain dynamics that underlie oxytocin's amplification of both trust and aggression; and specifically, using neuroimaging (fMRI, magnetoencephalography, and behavioral testing) whether oxytocin amplifies kinship bias by attenuating social reward learning.

Interventions

  • Syntocinon Nasal Spray, 40IUDrug
  • Syntocinon Placebo Formulation, 40IUDrug

Arms2

  • Active comparator

    Oxytocin

    Healthy adult subjects will receive several puffs of Syntocinon Nasal Spray, 40IU, once, prior to MRI and/or MEG scanning.

  • Placebo comparator

    Placebo

    Healthy adult subjects will receive several puffs of Syntocinon Placebo Formulation, 40IU, once, prior to MRI and/or MEG scanning.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Number of Benevolent Rounds

    Time frame · Immediately after completion of the study, for each subject.

    Registry description

    This study recruited healthy adults. Subjects participated in an interactive neuroeconomic game, an iterative version of the classical "Trust Study." During this game, the subject ('investor') is first provided a sum of money (20 units). He then has the choice in terms of how much to invest in a fictional computer-generated trustee. The trustee then sends some percentage back to the subject ('investor'), and the game iterates over 20 trials (rounds). We computed the investment ratio as the ratio of the actual investment and the maximum allowed amount of 20 units, and analogously for the repayment ratio. Benevolent rounds were defined as those with increased investment ratios even after a decreased repayment ratio.

  2. Number of Malevolent Rounds

    Time frame · Immediately after completion of the study, for each subject.

    Registry description

    This study recruited healthy adults. Subjects participated in an interactive neuroeconomic game, an iterative version of the classical "Trust Study." During this game, the subject ('investor') is first provided a sum of money (20 units). He then has the choice in terms of how much to invest in a fictional computer-generated trustee. The trustee then sends some percentage back to the subject ('investor'), and the game iterates over 20 trials (rounds). We computed the investment ratio as the ratio of the actual investment and the maximum allowed amount of 20 units, and analogously for the repayment ratio. Malevolent rounds were defined as those with decreased investment ratios even after an increased repayment ratio.

Secondary outcomes(1)
  1. Functional Connectivity Between OFC and AMY

    Time frame · Within two weeks of enrollment completion.

    Registry description

    During functional scans, subjects participated in an interactive neuroeconomic game, an iterative version of the classical "Trust Study." Subjects participated in an interactive neuroeconomic game, an iterative version of the classical "Trust Study." During this game, the subject ('investor') is first provided a sum of money (20 units). He then has the choice in terms of how much to invest in a fictional computer-generated trustee. The trustee then sends some percentage back to the subject ('investor'), and the game iterates over 20 trials (rounds). Using Dynamical Causal Modeling (DCM) we modeled the dynamic interaction between amygdala (AMY), nucleus accumbens (NAcc) and the orbitofrontal cortex (OFC). We observed altered connectivity strength between AMY and OFC under OT as compared to PL conditions.

Posted results

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

Primary outcome results

Primary outcomeMean· Immediately after completion of the study, for each subject.

Number of Benevolent Rounds

GroupValue (number of rounds)Spread
Oxytocin6.82.0
Placebo6.82.3
Primary outcomeMean· Immediately after completion of the study, for each subject.

Number of Malevolent Rounds

GroupValue (number of rounds)Spread
Oxytocin2.81.5
Placebo3.02.1
Secondary and other outcome results(1)
Secondary outcomeMean· Within two weeks of enrollment completion.

Functional Connectivity Between OFC and AMY

GroupValue (Hz)Spread
Oxytocin0.45NA
Placebo0.18NA

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Oxytocin, Then PlaceboSubjects who received oxytocin before their first scan, and placebo before their second scan.–0 / 200 / 20
Placebo, Then OxytocinSubjects who received placebo before their first scan, and oxytocin before their second scan.–0 / 190 / 19

Each cell reads participants affected / participants at risk, as the registry posted them.

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

Studies22

Studies that cite this trial.

Studies with results

11 studies on this page

Indexing hint: Clinical trial · 2011

3 results

Oxytocin can hinder trust and cooperation in borderline personality disorder.

Bartz et al. 2011Social cognitive and affective neurosciencecited by 266

PMID 21115541PMC3190211DOI 10.1093/scan/nsq085PUB-21115541

Rights unknown3 results

Indexing hint: Randomized controlled trial · 2011

2 results

Oxytocin promotes human ethnocentrism.

De Dreu et al. 2011Proceedings of the National Academy of Sciences of the United States of Americacited by 379

PMID 21220339PMC3029708DOI 10.1073/pnas.1015316108PUB-21220339

Rights unknown2 results

Indexing hint: Systematic review · 2011

3 results

A review of safety, side-effects and subjective reactions to intranasal oxytocin in human research.

MacDonald et al. 2011Psychoneuroendocrinologycited by 276

PMID 21429671DOI 10.1016/j.psyneuen.2011.02.015PUB-21429671

Full text at the publisher3 results

Indexing hint: Randomized controlled trial · 2010

2 results

Intranasal oxytocin improves emotion recognition for youth with autism spectrum disorders.

Guastella et al. 2010Biological psychiatrycited by 686

PMID 19897177DOI 10.1016/j.biopsych.2009.09.020PUB-19897177

Full text at the publisher2 results

Indexing hint: Systematic review · 2009

1 result

Novel and emerging treatments for autism spectrum disorders: a systematic review.

Rossignol et al. 2009Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatristscited by 85

PMID 19917212DOI 10.1177/104012370902100404PUB-19917212

Full text at the publisher1 result

Indexing hint: Randomized controlled trial · 2008

4 results

Oxytocin shapes the neural circuitry of trust and trust adaptation in humans.

Baumgartner et al. 2008Neuroncited by 700

PMID 18498743DOI 10.1016/j.neuron.2008.04.009PUB-18498743

Rights unknown4 results

Indexing hint: Randomized controlled trial · 2008

3 results

Effects of oxytocin and prosocial behavior on brain responses to direct and vicariously experienced pain.

Singer et al. 2008Emotion (Washington, D.C.)cited by 172

PMID 19102589PMC2672051DOI 10.1037/a0014195PUB-19102589

Rights unknown3 results

Indexing hint: Randomized controlled trial · 2007

2 results

Oxytocin improves "mind-reading" in humans.

Domes et al. 2007Biological psychiatrycited by 826

PMID 17137561DOI 10.1016/j.biopsych.2006.07.015PUB-17137561

Full text at the publisher2 results

Indexing hint: Randomized controlled trial · 2007

2 results

Oxytocin attenuates amygdala responses to emotional faces regardless of valence.

Domes et al. 2007Biological psychiatrycited by 588

PMID 17617382DOI 10.1016/j.biopsych.2007.03.025PUB-17617382

Full text at the publisher2 results

Indexing hint: Clinical trial · 2005

3 results

Oxytocin increases trust in humans.

Kosfeld et al. 2005Naturecited by 1,701

PMID 15931222DOI 10.1038/nature03701PUB-15931222

Full text at the publisher3 results

Indexing hint: Observational study · 2005

2 results

Oxytocin modulates neural circuitry for social cognition and fear in humans.

Kirsch et al. 2005The Journal of neuroscience : the official journal of the Society for Neurosciencecited by 1,030

PMID 16339042PMC6725903DOI 10.1523/jneurosci.3984-05.2005PUB-16339042

Free to read · publisher termsCC BY-NC2 results

More studies

11 studies on this page

PubMed tag: none · 2010

Effects of intranasal oxytocin on emotional face processing in women.

Domes et al. 2010Psychoneuroendocrinologycited by 418

PMID 19632787DOI 10.1016/j.psyneuen.2009.06.016PUB-19632787

Full text at the publisher
Publisher page

PubMed tag: none · 2010

Evidence for the involvement of genetic variation in the oxytocin receptor gene (OXTR) in the etiology of autistic disorders on high-functioning level.

Wermter et al. 2010American journal of medical genetics. Part B, Neuropsychiatric genetics : the official publication of the International Society of Psychiatric Geneticscited by 116

PMID 19777562DOI 10.1002/ajmg.b.31032PUB-19777562

Full text at the publisher
Publisher page

PubMed tag: none · 2010

Promoting social behavior with oxytocin in high-functioning autism spectrum disorders.

Andari et al. 2010Proceedings of the National Academy of Sciences of the United States of Americacited by 637

PMID 20160081PMC2840168DOI 10.1073/pnas.0910249107PUB-20160081

Rights unknown
Source link

Indexing hint: Review · 2010

The challenge of translation in social neuroscience: a review of oxytocin, vasopressin, and affiliative behavior.

Insel et al. 2010Neuroncited by 736

PMID 20346754PMC2847497DOI 10.1016/j.neuron.2010.03.005PUB-20346754

Rights unknown
Source link

PubMed tag: none · 2010

Evidence that genetic variation in the oxytocin receptor (OXTR) gene influences social cognition in ADHD.

Park et al. 2010Progress in neuro-psychopharmacology & biological psychiatrycited by 58

PMID 20347913DOI 10.1016/j.pnpbp.2010.03.029PUB-20347913

Full text at the publisher
Publisher page

Indexing hint: Review · 2010

Oxytocin and the salience of social cues.

Averbeck et al. 2010Proceedings of the National Academy of Sciences of the United States of Americacited by 50

PMID 20448196PMC2889126DOI 10.1073/pnas.1004892107PUB-20448196

Rights unknown
Source link

PubMed tag: none · 2010

Effects of oxytocin on recollections of maternal care and closeness.

Bartz et al. 2010Proceedings of the National Academy of Sciences of the United States of Americacited by 165

PMID 21115834PMC3003037DOI 10.1073/pnas.1012669107PUB-21115834

Rights unknown
Source link

PubMed tag: none · 2010

Inverse effects of oxytocin on attributing mental activity to others in depressed and healthy subjects: a double-blind placebo controlled FMRI study.

Pincus et al. 2010Frontiers in psychiatrycited by 69

PMID 21423444PMC3059627DOI 10.3389/fpsyt.2010.00134PUB-21423444

Rights unknown
Source link

PubMed tag: none · 2009

Genomic and epigenetic evidence for oxytocin receptor deficiency in autism.

Gregory et al. 2009BMC medicinecited by 418

PMID 19845972PMC2774338DOI 10.1186/1741-7015-7-62PUB-19845972

CC BY
Download PDF

PubMed tag: none · 2008

Fool me once, shame on you; fool me twice, shame on oxytocin.

Delgado et al. 2008Neuroncited by 11

PMID 18498730DOI 10.1016/j.neuron.2008.05.005PUB-18498730

Full text at the publisher
Publisher page

PubMed tag: none · 2008

Oxytocin attenuates affective evaluations of conditioned faces and amygdala activity.

Petrovic et al. 2008The Journal of neuroscience : the official journal of the Society for Neurosciencecited by 322

PMID 18579733PMC2647078DOI 10.1523/jneurosci.4572-07.2008PUB-18579733

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 18-45 years of age Exclusion Criteria: * any significant known medical condition, including mental disorders (confounds interpretation of brain activity) * metal in the body or claustrophobia (contraindicated for fMRI) * current use of any type of psychotropic medication (confounds interpretation of brain activity) * body mass index of greater than 30 (to permit matched dosing across subjects) * pregnancy (contraindicated for OT) * breastfeeding (lactation endogenously triggers OT, which would not permit a placebo condition) * smoking (affects use of nasal spray) * use of drugs of abuse (confounds interpretation of brain activity) * blood pressure above the normal range (140/90 mm Hg) or controlled with medication (may theoretically increase risk for OT side-effects) * anosmia (affects use of nasal spray)

PepBank is a research reference. Talk to a doctor before you use any peptide.