Brain Dynamics in Healthy AdultsPhase 1NCT01834261

Brain Dynamics of Oxytocin

A Phase 1 study testing Syntocinon Nasal Spray, 40IU in people with Brain Dynamics in Healthy Adults, run by Stony Brook University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Brain Dynamics in Healthy Adults
What is being tested?: Syntocinon Nasal Spray, 40IU
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 51 participants
Where: 3 sitesUnited States
Study dates: Apr 2013to May 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

18-45 years of age

Who cannot join

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)

Show all 10Show fewer

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)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Martinos Imaging Center at the McGovern Institute for Brain Research at MIT
Cambridge, Massachusetts, 02139
Martinos Center for Biomedical Research, Building 149, 13th Street
Charlestown, Massachusetts, 02129
Bioengineering Building , Stony Brook University
Stony Brook, New York, 11794

Other trials in United States

About this study

Official title: Computational Modeling of Oxytocin in the Regulation of Trust

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.

Read the detailed description

The purpose of the study is to understand how oxytocin affects brain and behavior. The study will compare Syntocinon Nasal Spray to placebo. The specific aims are to:

Determine the default circuitry of oxytocin (OT).
Determine time-course and gender differences for default neural response to OT.
Using an iterative version of the classical neuroeconomic game (Trust Study), behaviorally test whether OT down-regulates reward learning, thereby enhancing the effects of kinship bias, to account for the polarizing effects (in which OT increases trust for 'in-groups' and increases aggression for 'out-groups').
Identify the down-regulation of reward learning neurobiologically, via data-driven control systems modeling of the reward circuit using MRI (fMRI: time-series analysis of the orbitofrontal cortex, amygdala, anterior and posterior cingulate, and nucleus accumbens, and magnetic resonance spectroscopy: focusing on gamma-Aminobutyric acid neurotransmitters within the nucleus accumbens) and magnetoencephalography (focusing on the dynamics within the prefrontal cortex). FMRI and MRS will be conducted during the same MRI scan, while MEG will be conducted separately.

STUDY PROCEDURES:

Nasal Obstruction/Anosmia Screening: All potential subjects will be screened for total or partial anosmia and nasal congestion using the University of Pennsylvania Smell Identification Test (Psychological Assessment Resources, Lutz FL).

Pregnancy and Lactation Screening: Oxytocin is often used clinically to trigger labor in late-stage pregnancy. Although none of our subjects will be in late-stage pregnancy and subjects will be receiving dosages far smaller that those used to trigger labor, to be safe all potential female subjects will be urine screened for pregnancy immediately during the history and physical. Lactation screening will be performed via self-report, and is conducted to avoid confounds due to endogenously produced OT during the milk-ejection reflex.

Oxytocin/Placebo Procedures: Oxytocin intranasal spray is manufactured as the Syntocinon Nasal Spray. The typical dose oxytocin of for short-term intranasal use is 40IU, and has an expected half-life of 20 minutes. Placebos, identical in preparation except for the oxytocin component, will be administered in the same manner in a double blind procedure. To avoid bleed-through between conditions while controlling for order effects, sessions will not be mixed between drug and placebo conditions: each session, conducted on separate days, will be either 'drug' or 'placebo.'

Scanning Procedures: Scanning procedure for MRI will include: structural scan (6 minutes), fMRI or MRS resting state (10 minutes), and a neuroeconomic task scan (10 minutes). Scanning procedure for MEG will include: resting state (10 minutes), and a neuroeconomic task scan (20 minutes).

Behavioral Task: During scans, subjects will participate 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. He then has the choice in terms of how much to invest in a fictional computer-generated trustee or, in forced-choice versions, to choose between different trustees. The trustee then sends some percentage back to the subject ('investor'), and the game iterates over many trials. Previous research has shown that OT disrupts participant's use of the optimal solution, eliciting greater "trust" in the trustee than would be expected by Nash Equilibrium. To modulate reward learning, algorithms for trustee behavior will be modulated towards greater and lesser generosity. To modulate kinship bias, trustees will be represented on the screen using faces of greater and lesser similarity to that of the subject, created using MorphMan video-editing software (STOIK Imaging, Moscow Russia).

Conditions: Brain Dynamics in Healthy Adults
Being tested: Syntocinon Nasal Spray, 40IU, Syntocinon Placebo Formulation, 40IU
Keywords: oxytocin, trust, kinship, kin selection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Syntocinon Nasal Spray, 40IUDrug
Subjects will be scanned twice. Prior to first brain scanning session, they will be randomly assigned to receive either Syntocinon or Placebo. Prior to second scanning session, they will receive what they have not received in the first session; i.e., same subjects will be receiving both Syntocinon and placebo on two different days.
Syntocinon Placebo Formulation, 40IUDrug
Subjects will be scanned twice. Prior to first brain scanning session, they will be randomly assigned to receive either Syntocinon or Placebo. Prior to second scanning session, they will receive what they have not received in the first session; i.e., same subjects will be receiving both Syntocinon and placebo on two different days.

Study groups in NCT01834261
Study group	Role	What they receive
Oxytocin	Active comparator	Healthy adult subjects will receive several puffs of Syntocinon Nasal Spray, 40IU, once, prior to MRI and/or MEG scanning. Receives: Drug: Syntocinon Nasal Spray, 40IU; Drug: Syntocinon Placebo Formulation, 40IU
Placebo	Placebo comparator	Healthy adult subjects will receive several puffs of Syntocinon Placebo Formulation, 40IU, once, prior to MRI and/or MEG scanning. Receives: Drug: Syntocinon Nasal Spray, 40IU; Drug: Syntocinon Placebo Formulation, 40IU

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Benevolent Rounds
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.
Measured: Immediately after completion of the study, for each subject.
Number of Malevolent Rounds
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.
Measured: Immediately after completion of the study, for each subject.

Secondary outcomes (1)

Functional Connectivity Between OFC and AMY
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.
Measured: Within two weeks of enrollment completion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013May 2015

First posted17 Apr 2013 (estimated)
Study startApr 2013
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Brain Dynamics in Healthy AdultsStudies of the same condition, open and under way.
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
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01834261
Sponsor's protocol ID: 293408
Other IDs: N000141210393
Status last verified: Jan 2017
First submitted: 12 Apr 2013
Last updated: 17 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Averbeck BB. Oxytocin and the salience of social cues. Proc Natl Acad Sci U S A. 2010 May 18;107(20):9033-4. doi: 10.1073/pnas.1004892107. Epub 2010 May 6. No abstract available.
PubMed 20448196
Insel TR. The challenge of translation in social neuroscience: a review of oxytocin, vasopressin, and affiliative behavior. Neuron. 2010 Mar 25;65(6):768-79. doi: 10.1016/j.neuron.2010.03.005.
PubMed 20346754
Baumgartner T, Heinrichs M, Vonlanthen A, Fischbacher U, Fehr E. Oxytocin shapes the neural circuitry of trust and trust adaptation in humans. Neuron. 2008 May 22;58(4):639-50. doi: 10.1016/j.neuron.2008.04.009.
PubMed 18498743
Delgado MR. Fool me once, shame on you; fool me twice, shame on oxytocin. Neuron. 2008 May 22;58(4):470-1. doi: 10.1016/j.neuron.2008.05.005.
PubMed 18498730
Kosfeld M, Heinrichs M, Zak PJ, Fischbacher U, Fehr E. Oxytocin increases trust in humans. Nature. 2005 Jun 2;435(7042):673-6. doi: 10.1038/nature03701.
PubMed 15931222
Wermter AK, Kamp-Becker I, Hesse P, Schulte-Korne G, Strauch K, Remschmidt H. Evidence for the involvement of genetic variation in the oxytocin receptor gene (OXTR) in the etiology of autistic disorders on high-functioning level. Am J Med Genet B Neuropsychiatr Genet. 2010 Mar 5;153B(2):629-639. doi: 10.1002/ajmg.b.31032.
PubMed 19777562
Park J, Willmott M, Vetuz G, Toye C, Kirley A, Hawi Z, Brookes KJ, Gill M, Kent L. Evidence that genetic variation in the oxytocin receptor (OXTR) gene influences social cognition in ADHD. Prog Neuropsychopharmacol Biol Psychiatry. 2010 May 30;34(4):697-702. doi: 10.1016/j.pnpbp.2010.03.029. Epub 2010 Mar 27.
PubMed 20347913
Gregory SG, Connelly JJ, Towers AJ, Johnson J, Biscocho D, Markunas CA, Lintas C, Abramson RK, Wright HH, Ellis P, Langford CF, Worley G, Delong GR, Murphy SK, Cuccaro ML, Persico A, Pericak-Vance MA. Genomic and epigenetic evidence for oxytocin receptor deficiency in autism. BMC Med. 2009 Oct 22;7:62. doi: 10.1186/1741-7015-7-62.
PubMed 19845972
Andari E, Duhamel JR, Zalla T, Herbrecht E, Leboyer M, Sirigu A. Promoting social behavior with oxytocin in high-functioning autism spectrum disorders. Proc Natl Acad Sci U S A. 2010 Mar 2;107(9):4389-94. doi: 10.1073/pnas.0910249107. Epub 2010 Feb 16.
PubMed 20160081
Guastella AJ, Einfeld SL, Gray KM, Rinehart NJ, Tonge BJ, Lambert TJ, Hickie IB. Intranasal oxytocin improves emotion recognition for youth with autism spectrum disorders. Biol Psychiatry. 2010 Apr 1;67(7):692-4. doi: 10.1016/j.biopsych.2009.09.020. Epub 2009 Nov 7.
PubMed 19897177
Rossignol DA. Novel and emerging treatments for autism spectrum disorders: a systematic review. Ann Clin Psychiatry. 2009 Oct-Dec;21(4):213-36.
PubMed 19917212
Opar A. Search for potential autism treatments turns to 'trust hormone'. Nat Med. 2008 Apr;14(4):353. doi: 10.1038/nm0408-353. No abstract available.
PubMed 18391923
Bartz J, Simeon D, Hamilton H, Kim S, Crystal S, Braun A, Vicens V, Hollander E. Oxytocin can hinder trust and cooperation in borderline personality disorder. Soc Cogn Affect Neurosci. 2011 Oct;6(5):556-63. doi: 10.1093/scan/nsq085. Epub 2010 Nov 29.
PubMed 21115541
Bartz JA, Zaki J, Ochsner KN, Bolger N, Kolevzon A, Ludwig N, Lydon JE. Effects of oxytocin on recollections of maternal care and closeness. Proc Natl Acad Sci U S A. 2010 Dec 14;107(50):21371-5. doi: 10.1073/pnas.1012669107. Epub 2010 Nov 29.
PubMed 21115834
Hahn-Holbrook J, Holt-Lunstad J, Holbrook C, Coyne SM, Lawson ET. Maternal defense: breast feeding increases aggression by reducing stress. Psychol Sci. 2011 Oct;22(10):1288-95. doi: 10.1177/0956797611420729. Epub 2011 Aug 26.
PubMed 21873570

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Computational Modeling of Oxytocin in the Regulation of Trust
ClinicalTrials.gov ID: NCT01834261
Acronym / sponsor ID: 293408
Conditions: Brain Dynamics in Healthy Adults
Keywords: oxytocin, trust, kinship, kin selection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Stony Brook UniversityUniversity, hospital or other
Collaborators: Martinos Center for Biomedical Imaging
Study start: Apr 2013
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 17 Apr 2013 (estimated)
Results: Posted 17 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The purpose of the study is to understand how oxytocin affects brain and behavior. The study will compare Syntocinon Nasal Spray to placebo. The specific aims are to:

Determine the default circuitry of oxytocin (OT).
Determine time-course and gender differences for default neural response to OT.
Using an iterative version of the classical neuroeconomic game (Trust Study), behaviorally test whether OT down-regulates reward learning, thereby enhancing the effects of kinship bias, to account for the polarizing effects (in which OT increases trust for 'in-groups' and increases aggression for 'out-groups').
Identify the down-regulation of reward learning neurobiologically, via data-driven control systems modeling of the reward circuit using MRI (fMRI: time-series analysis of the orbitofrontal cortex, amygdala, anterior and posterior cingulate, and nucleus accumbens, and magnetic resonance spectroscopy: focusing on gamma-Aminobutyric acid neurotransmitters within the nucleus accumbens) and magnetoencephalography (focusing on the dynamics within the prefrontal cortex). FMRI and MRS will be conducted during the same MRI scan, while MEG will be conducted separately.

STUDY PROCEDURES:

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Oxytocin	Active comparator	Drug: Syntocinon Nasal Spray, 40IU, Drug: Syntocinon Placebo Formulation, 40IUHealthy adult subjects will receive several puffs of Syntocinon Nasal Spray, 40IU, once, prior to MRI and/or MEG scanning.
Placebo	Placebo comparator	Drug: Syntocinon Nasal Spray, 40IU, Drug: Syntocinon Placebo Formulation, 40IUHealthy adult subjects will receive several puffs of Syntocinon Placebo Formulation, 40IU, once, prior to MRI and/or MEG scanning.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

18-45 years of age

Key exclusion criteria (10 listed)

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)

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
Syntocinon Nasal Spray, 40IUSubjects will be scanned twice. Prior to first brain scanning session, they will be randomly assigned to receive either Syntocinon or Placebo. Prior to second scanning session, they will receive what they have not received in the first session; i.e., same subjects will be receiving both Syntocinon and placebo on two different days.	Drug	Oxytocin, Placebo
Syntocinon Placebo Formulation, 40IUSubjects will be scanned twice. Prior to first brain scanning session, they will be randomly assigned to receive either Syntocinon or Placebo. Prior to second scanning session, they will receive what they have not received in the first session; i.e., same subjects will be receiving both Syntocinon and placebo on two different days.	Drug	Oxytocin, Placebo

Primary outcome

Number of Benevolent Rounds
Time frame: Immediately after completion of the study, for each subject.
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.
Number of Malevolent Rounds
Time frame: Immediately after completion of the study, for each subject.
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.

1 secondary outcome

Functional Connectivity Between OFC and AMY
Time frame: Within two weeks of enrollment completion.

Results and safety

Results posted to the registry on 17 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxytocin, Then Placebo	11	10
Placebo, Then Oxytocin	10	9

Primary outcome: Number of Benevolent Rounds

Time frame: Immediately after completion of the study, for each subject.. Mean (Standard Deviation). Unit: number of rounds

Measure	Oxytocin n = 17	Placebo n = 17
Value	6.8 (2.0)	6.8 (2.3)

Population analysed: Healthy adult men.

Primary outcome: Number of Malevolent Rounds

Time frame: Immediately after completion of the study, for each subject.. Mean (Standard Deviation). Unit: number of rounds

Measure	Oxytocin n = 17	Placebo n = 17
Value	2.8 (1.5)	3.0 (2.1)

Population analysed: Healthy adult men.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxytocin, Then Placebo	0 of 20 (0%)	0 of 20 (0%)	Not reported
Placebo, Then Oxytocin	0 of 19 (0%)	0 of 19 (0%)	Not reported

Limitations and caveats (from the sponsor): Data collection has been completed, but data analysis is ongoing.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20448196Averbeck BB. Oxytocin and the salience of social cues. Proc Natl Acad Sci U S A. 2010 May 18;107(20):9033-4. doi: 10.1073/pnas.1004892107. Epub 2010 May 6. No abstract available.
Background: PubMed 20346754Insel TR. The challenge of translation in social neuroscience: a review of oxytocin, vasopressin, and affiliative behavior. Neuron. 2010 Mar 25;65(6):768-79. doi: 10.1016/j.neuron.2010.03.005.
Background: PubMed 18498743Baumgartner T, Heinrichs M, Vonlanthen A, Fischbacher U, Fehr E. Oxytocin shapes the neural circuitry of trust and trust adaptation in humans. Neuron. 2008 May 22;58(4):639-50. doi: 10.1016/j.neuron.2008.04.009.
Background: PubMed 18498730Delgado MR. Fool me once, shame on you; fool me twice, shame on oxytocin. Neuron. 2008 May 22;58(4):470-1. doi: 10.1016/j.neuron.2008.05.005.
Background: PubMed 15931222Kosfeld M, Heinrichs M, Zak PJ, Fischbacher U, Fehr E. Oxytocin increases trust in humans. Nature. 2005 Jun 2;435(7042):673-6. doi: 10.1038/nature03701.
Background: PubMed 19777562Wermter AK, Kamp-Becker I, Hesse P, Schulte-Korne G, Strauch K, Remschmidt H. Evidence for the involvement of genetic variation in the oxytocin receptor gene (OXTR) in the etiology of autistic disorders on high-functioning level. Am J Med Genet B Neuropsychiatr Genet. 2010 Mar 5;153B(2):629-639. doi: 10.1002/ajmg.b.31032.
Background: PubMed 20347913Park J, Willmott M, Vetuz G, Toye C, Kirley A, Hawi Z, Brookes KJ, Gill M, Kent L. Evidence that genetic variation in the oxytocin receptor (OXTR) gene influences social cognition in ADHD. Prog Neuropsychopharmacol Biol Psychiatry. 2010 May 30;34(4):697-702. doi: 10.1016/j.pnpbp.2010.03.029. Epub 2010 Mar 27.
Background: PubMed 19845972Gregory SG, Connelly JJ, Towers AJ, Johnson J, Biscocho D, Markunas CA, Lintas C, Abramson RK, Wright HH, Ellis P, Langford CF, Worley G, Delong GR, Murphy SK, Cuccaro ML, Persico A, Pericak-Vance MA. Genomic and epigenetic evidence for oxytocin receptor deficiency in autism. BMC Med. 2009 Oct 22;7:62. doi: 10.1186/1741-7015-7-62.
Background: PubMed 20160081Andari E, Duhamel JR, Zalla T, Herbrecht E, Leboyer M, Sirigu A. Promoting social behavior with oxytocin in high-functioning autism spectrum disorders. Proc Natl Acad Sci U S A. 2010 Mar 2;107(9):4389-94. doi: 10.1073/pnas.0910249107. Epub 2010 Feb 16.
Background: PubMed 19897177Guastella AJ, Einfeld SL, Gray KM, Rinehart NJ, Tonge BJ, Lambert TJ, Hickie IB. Intranasal oxytocin improves emotion recognition for youth with autism spectrum disorders. Biol Psychiatry. 2010 Apr 1;67(7):692-4. doi: 10.1016/j.biopsych.2009.09.020. Epub 2009 Nov 7.
Background: PubMed 19917212Rossignol DA. Novel and emerging treatments for autism spectrum disorders: a systematic review. Ann Clin Psychiatry. 2009 Oct-Dec;21(4):213-36.
Background: PubMed 18391923Opar A. Search for potential autism treatments turns to 'trust hormone'. Nat Med. 2008 Apr;14(4):353. doi: 10.1038/nm0408-353. No abstract available.
Lab WebsiteLink provided by the sponsor.

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.

Lilianne Mujica-Parodi, PhD principal investigator

Stony Brook University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Syntocinon Nasal Spray, 40IU in people with Brain Dynamics in Healthy Adults, run by Stony Brook University at 3 sites 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Benevolent Rounds (time frame: Immediately after completion of the study, for each subject.). 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 NCT01834261, which also lists 25 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 17 Mar 2017.