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Trial · Interventional

CompletedEarly phase 1Registry data

Oxytocin and the Social Brain

Overview

Status
Completed
Phase
Early phase 1
Enrollment
161 participants (actual)
Sponsor
University of California, Los Angeles · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Jan 2015
Primary completion
Jul 2016
Completion
Jul 2016
First posted
19 Mar 2015 (estimated)
Last update posted
10 Aug 2017
Conditions
Social Psychology

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017
  1. Ph Early 1

    Oxytocin and the Social Brain

    NCT02393456

    Jan 2015 to Jul 2016

Registry summary

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

It has long been established that interpersonal relationships can have a profound impact on health and well-being. Yet, the investigators are still learning about the complex biological processes that contribute to positive social interactions and the ability to develop and maintain social relationships. Recent research has begun to focus on oxytocin, a neuropeptide that is naturally produced in the hypothalamus, because administration of this neuropeptide has been associated with increased trust, generosity, empathy, cooperation, memory of social stimuli (e.g., faces), and brain activity in neural regions associated with social and emotional processes. To date, several aspects of oxytocin's effects on social behavior have been unexplored. As such, the overarching goal of this project is to examine the effects of intranasal oxytocin on several tasks involving social processes. In addition, the investigators will explore associated neural activity through functional magnetic resonance imaging (fMRI). Understanding how oxytocin influences these aspects of social functioning will help to inform research that has begun to establish the potential for use of this neuropeptide in education as well as psychiatric disorders such as autism spectrum disorders and schizophrenia that are characterized by social deficits. The investigators hypothesize that compared to placebo, oxytocin will improve deception detection, increase empathy and altruism, and enhance responses to photo stimuli of primary caregivers. These effects will manifest in behavioral and neural activity. It is also hypothesized that main effects will not be found for oxytocin, but rather, analyses of relevant moderators will elucidate these findings.

Interventions

  • Intranasal oxytocinDrug
  • Intranasal placeboDrug

Arms2

  • Experimental

    Intranasal oxytocin

    Participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).

  • Placebo comparator

    Intranasal placebo

    2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter. Participants will self-administer 5 puffs per nostril.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Changes in neural brain activity, as observed by fMRI, when observing others during social inclusion vs. exclusion

    Time frame · Between 40-115 minutes post administration

    Registry description

    Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the oxytocin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater during the exclusion portion of the cyberball task versus the inclusion portion. A first-level analysis will compare \[(friend exclusion\>friend inclusion)\>(stranger exclusion\>stranger inclusion)\] for each participant. A second-level group analysis will compare these first-level contrasts between the oxytocin and placebo groups.

Secondary outcomes(5)
  1. Ratings of empathic concern after witnessing social exclusion in a friend or a stranger

    Time frame · Between 40-115 minutes post administration

    Registry description

    Ratings of empathic concern will be calculated for each participant by deriving a composite from self-report ratings of sympathy and compassion. Using a mixed 2 (friend, stranger) x 2 (oxytocin, placebo) factorial design, comparisons of these ratings will then be made for those in the oxytocin vs. placebo groups. Main effects of drug condition (oxytocin, placebo) as well as the interaction between drug condition and target (friend, stranger) will be analyzed at a significance level of p\<.05.

  2. Altruism and punishment as measured by number of points given to excluders and those excluded

    Time frame · Between 40-115 minutes post administration

    Registry description

    Ratings of altruism and punishment will be calculated by examining how many point (1-10) participants decide to allocate towards the friend-excluder, stranger-excluder, excluded friend, and excluded stranger after watching each social exclusion game. Using a mixed 2 (friend, stranger) x 2 (oxytocin, placebo) factorial design, comparisons of these ratings will then be made for those in the oxytocin vs. placebo groups. Main effects of drug condition (oxytocin, placebo) and target (friend, stranger), as well as an interaction between drug condition and target will be analyzed at a significance level of p\<.05.

  3. Changes in neural brain activity, as observed by fMRI, while attempting to detect deception

    Time frame · Between 40-115 minutes post administration

    Registry description

    Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the oxytocin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater during the deception detection task versus a control task. A first-level analysis will compare deception-detection\>control for each participant. A second-level group analysis will compare this first-level contrast between the oxytocin and placebo groups.

  4. Accuracy of deception detection as measured by self-report

    Time frame · Between 40-115 minutes post administration

    Registry description

    We will compare the percentage of correct deception detection trials for participants in the oxytocin group to those in the placebo group by running a two-tailed t-test with a statistical cutoff of p\<.05 to determine significance.

  5. Changes in neural brain activity, as observed by fMRI, when viewing images of primary caregivers versus strangers

    Time frame · Between 40-115 minutes post administration

    Registry description

    Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the oxytocin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater while viewing photo stimuli of ones primary caregivers versus viewing photo stimuli of matched strangers. A first-level analysis will compare primary-caregiver-viewing\>stranger-viewing for each participant. A second-level group analysis will compare this first-level contrast between the oxytocin and placebo groups.

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.

Completed trials do not always post results.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

5 results

Null results of oxytocin and vasopressin administration on mentalizing in a large fMRI sample: evidence from a randomized controlled trial.

Straccia et al. 2023Psychological medicinecited by 17

PMID 37310308PMC10123837DOI 10.1017/s0033291721004104PUB-37310308

CC BY5 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 30 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 18-30 years of age * Healthy (see below) * Fluent in English * Right-handed Exclusion Criteria: * Women who gave birth in the last six months, are currently pregnant, planning to become pregnant in the next 6 months, or currently breastfeeding women * Symptoms of runny nose due to allergies/cold or other reason * Current restricted fluid intake for any reason * Heart disease * Hypertension * History of myocardial infarction * History of cardiac arrhythmia * Kidney or liver disease * Vascular disease * Epilepsy * Migraine * Asthma * Nephritis * Diabetes and other endocrine diseases * Frequent or unexplained fainting * History of stroke * Aneurysm or brain hemorrhage * Active psychiatric diagnosis * Current psychopharmacologic treatment * Drug or alcohol abuse * Medical or neurological illness * Regular use of medication (e.g., vasoconstrictive medications) * Medication intake less than 2 weeks prior to study (5 weeks for fluoxetine) including daily non-steroidal anti-inflammatory drugs * Smoking more than 15 cigarettes a day * Consumption of any alcoholic beverages in the past 24 hours will be excluded * Elevated blood pressure (\>135/90) * Low blood pressure (\<90/55) * Body temperature \>100.1 F * Left-handed * Claustrophobia * Presence of metal in their body

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