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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Biological Basis of Individual Variation in Social Cooperation

NCTNCT01566539 (opens ClinicalTrials.gov in a new tab)Other idIRB00007905Other id1R01MH084068-01A1Other idMH087721-01A1

Overview

Status
Completed
Phase
Not applicable
Enrollment
707 participants (actual)
Sponsor
Emory University · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Apr 2008
Primary completion
Nov 2016
Completion
Nov 2016
First posted
29 Mar 2012 (estimated)
Last update posted
25 Sept 2017
Conditions
Healthy

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082010201220142016
  1. N/A

    Biological Basis of Individual Variation in Social Cooperation

    NCT01566539

    Apr 2008 to Nov 2016

Registry summary

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

The project has three overall objectives. The first is to determine whether and how administration of intranasal oxytocin (OT) and intranasal vasopressin (AVP) influence cooperative decision-making and neural responses to cooperative and un-cooperative social interactions. The second is to determine whether and how intranasal vasopressin influences subjective evaluations of and neural responses to same and opposite-sex face stimuli and to determine if any of these effects persist beyond the period of AVP exposure. The third objective is to determine if intranasal OT influences empathy-related behavior and associated brain activity.

Interventions

  • Intranasal Oxytocin (OT) 24 IUDrug
  • Intranasal Vasopressin (AVP)Drug
  • Intranasal PlaceboDrug
  • Intranasal Vasopressin (AVP) 40 IUDrug
  • LorazepamDrug

Arms11

  • Experimental

    Healthy Volunteers - Intranasal Vasopressin (AVP)

    The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.

  • Experimental

    Healthy Volunteers - Intranasal Oxytocin (OT)

    The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.

  • Placebo comparator

    Healthy Volunteers - Intranasal Placebo

    The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.

  • Experimental

    Within Subject Group

    Some healthy volunteer participants who received drug in their first session will receive placebo in their second session and vice-versa prior to completing the PD task. For each gender, half will receive AVP in one session and placebo in the other session, and half will receive OT in one session and placebo in the second session. In each group, half of the subjects will receive drug first and half will receive placebo first. Additionally, a group of subjects who receive placebo the first time will receive placebo the second time.

  • Experimental

    Faces Task - Vasopressin (AVP)

    Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.

  • Placebo comparator

    Faces Task - Placebo

    Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.

  • Experimental

    Empathy Task - Oxytocin (OT)

    Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and OT at scan 2 prior to completing an empathy task.

  • Placebo comparator

    Empathy Task - Placebo

    Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and placebo at scan 2 prior to completing an empathy task.

  • Experimental

    Anxious and Depressed Subjects - OT

    Depressed or anxious men between the ages of 18 and 22 will receive intranasal OT prior to completing the Prisoner's Dilemma game task and MRI scan.

  • Placebo comparator

    Anxious and Depressed Subjects - Placebo

    Depressed or anxious men between the ages of 18 and 22 will receive intranasal placebo prior to completing the Prisoner's Dilemma game task and MRI scan.

  • Experimental

    Healthy Volunteers - Lorazepam

    Healthy normal men between the ages of 18 and 22 will receive lorazepam prior to completing the Prisoner's Dilemma game task and MRI scan.

Primary outcomes5

Outcomes the sponsor listed as primary.

  1. Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men

    Time frame · Visit 1 (40-100 Minutes Post-Intervention)

    Registry description

    The effect of the drug treatment will be assessed by determining differences in brain activation between OT and placebo groups in the right caudate nucleus region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.

  2. Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Women

    Time frame · Visit 1 (40-100 Minutes Post-Intervention)

    Registry description

    The effect of the drug treatment will be assessed by determining differences in brain activation between OT and placebo groups in the right caudate nucleus region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.

  3. Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Men

    Time frame · Visit 1 (40-100 Minutes Post-Intervention)

    Registry description

    The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and placebo groups in the left insula region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.

  4. Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Women

    Time frame · Visit 1 (40-100 Minutes Post-Intervention)

    Registry description

    The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and placebo groups in the left insula during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.

  5. Within Subject Group: Mean Percent Signal Change in Left Caudate Nucleus in Men and Women

    Time frame · Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)

    Registry description

    The effect of the drug will be assessed by determining changes in brain activation between the visit where the participant received drug and the visit where the participant received PL in the right caudate during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.

Secondary outcomes(12)
  1. Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Men During the Prisoners Dilemma Game

    Time frame · Visit 1 (40-100 Minutes Post-Intervention)

    Registry description

    The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered "cooperative". The higher the total number, the more cooperative choices made.

  2. Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Women During the Prisoners Dilemma Game

    Time frame · Visit 1 (40-100 Minutes Post-Intervention)

    Registry description

    The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered "cooperative". The higher the total number, the more cooperative choices made.

  3. Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Male During the Prisoners Dilemma Game

    Time frame · Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)

    Registry description

    The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered "cooperative". The higher the total number, the more cooperative choices made.

  4. Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Female During the Prisoners Dilemma Game

    Time frame · Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)

    Registry description

    The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered "cooperative". The higher the total number, the more cooperative choices made.

  5. Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Men

    Time frame · Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)

    Registry description

    The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.

  6. Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Women

    Time frame · Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)

    Registry description

    The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.

  7. Faces Task Groups: Mean Approachability Rating of Faces in Men

    Time frame · Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)

    Registry description

    Approachability is rated by a study specific seven point scale where -3 indicates threatening and unapproachable and +3 indicates friendly and approachable. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in approachability ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.

  8. Faces Task Group: Mean Approachability Rating of Faces in Women

    Time frame · Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)

    Registry description

    Approachability is rated by a study specific seven point scale where -3 indicates threatening and unapproachable and +3 indicates friendly and approachable. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in approachability ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.

  9. Faces Task Groups: Mean Attractiveness Rating of Faces in Men

    Time frame · Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)

    Registry description

    Attractiveness is rated by a study specific seven point scale where -3 indicates least attractive and +3 indicates most attractive. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in attractiveness ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.

  10. Faces Task Groups: Mean Attractiveness Rating of Faces in Women

    Time frame · Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)

    Registry description

    Attractiveness is rated by a study specific seven point scale where -3 indicates least attractive and +3 indicates most attractive. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in attractiveness ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.

  11. Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Women

    Time frame · Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month)

    Registry description

    The effect of the drug treatment will be assessed by determining differences in brain activation between OT and PL group when participants are viewing animations.

  12. Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Men

    Time frame · Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month)

    Registry description

    The effect of the drug treatment will be assessed by determining differences in brain activation between OT and PL group when participants are viewing animations.

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· Visit 1 (40-100 Minutes Post-Intervention)

Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men

GroupValue (percent signal change)Spread
Healthy Volunteers - Intranasal Oxytocin (OT)0.210.03
Healthy Volunteers - Intranasal Placebo0.070.02
Primary outcomeMean· Visit 1 (40-100 Minutes Post-Intervention)

Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Women

GroupValue (percent signal change)Spread
Healthy Volunteers - Intranasal Oxytocin (OT)0.040.02
Healthy Volunteers - Intranasal Placebo0.150.02
Primary outcomeMean· Visit 1 (40-100 Minutes Post-Intervention)

Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Men

GroupValue (percent signal change)Spread
Healthy Volunteers - Intranasal Vasopressin (AVP)0.130.02
Healthy Volunteers - Intranasal Placebo-0.020.02
Primary outcomeMean· Visit 1 (40-100 Minutes Post-Intervention)

Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Women

GroupValue (percent signal change)Spread
Healthy Volunteers - Intranasal Vasopressin (AVP)-0.050.03
Healthy Volunteers - Intranasal Placebo0.100.03
Primary outcomeMean· Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)

Within Subject Group: Mean Percent Signal Change in Left Caudate Nucleus in Men and Women

GroupValue (percent signal change)Spread
Within Subject Group0.210.19
Secondary and other outcome results(3)
Secondary outcomeMean· Visit 1 (40-100 Minutes Post-Intervention)

Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Men During the Prisoners Dilemma Game

GroupValue (number of choices)Spread
Healthy Volunteers - Intranasal Vasopressin (AVP)15.710.98
Healthy Volunteers - Intranasal Oxytocin (OT)16.181.01
Healthy Volunteers - Intranasal Placebo17.680.93
Secondary outcomeMean· Visit 1 (40-100 Minutes Post-Intervention)

Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Women During the Prisoners Dilemma Game

GroupValue (number of choices)Spread
Healthy Volunteers - Intranasal Vasopressin (AVP)15.840.76
Healthy Volunteers - Intranasal Oxytocin (OT)18.141.03
Healthy Volunteers - Intranasal Placebo16.920.98
Secondary outcomeMean· Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)

Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Male During the Prisoners Dilemma Game

GroupValue (number of choices)Spread
Within Subject Group-1.105.21

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Healthy Volunteers - Intranasal Vasopressin (AVP)The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task. Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).0 / 1010 / 1013 / 101
Healthy Volunteers - Intranasal Oxytocin (OT)The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task. Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.0 / 1000 / 1004 / 100
Healthy Volunteers - Intranasal PlaceboThe placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task. Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.0 / 1040 / 10412 / 104
Within Subject GroupSome healthy volunteer participants who received drug in their first session will receive placebo in their second session and vice-versa prior to completing the PD task. For each gender, half will receive AVP in one session and placebo in the other session, and half will receive OT in one session and placebo in the second session. In each group, half of the subjects will receive drug first and half will receive placebo first. Additionally, a group of subjects who receive placebo the first time will receive placebo the second time. Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total. Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total). Intranasal Placebo: Participants will receive placebo sprays that are pH0 / 1560 / 1560 / 156
Faces Task - Vasopressin (AVP)Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning. Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP.0 / 400 / 400 / 40
Faces Task - PlaceboHealthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning. Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.0 / 430 / 431 / 43
Empathy Task - Oxytocin (OT)Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and OT at scan 2 prior to completing an empathy task. Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total. Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.0 / 300 / 300 / 30
Empathy Task - PlaceboHealthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and placebo at scan 2 prior to completing an empathy task. Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.0 / 300 / 300 / 30
Healthy Volunteers - LorazepamHealthy normal men between the ages of 18 and 22 will receive lorazepam prior to completing the Prisoner's Dilemma game task and MRI scan. Lorazepam: Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan.0 / 10 / 10 / 1

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

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

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 * 21-30 for Faces component * Normal or corrected-to-normal vision of 20/40 * Unmedicated depressed or anxious men between 18-22 years of age for Anxious and Depressed component Exclusion Criteria: * Pregnancy, recent birth, or breastfeeding * History of seizures * Neurological Disorder * Current psychiatric disorder * Previous psychiatric disorder (can be included as discretion of PI) * Current use of psychoactive drugs * Previous use of psychoactive drugs (can be included as discretion of PI) * Previous head trauma (can be included at discretion of PI) * Alcoholism or substance abuse * Hypertension * Cardiovascular Disease * Nephritis * Diabetes * Endocrine disease or malignancy * Asthma (can be included as discretion of PI, if episodes are infrequent, nonmedicated, and no active problems at time of study) * Migraines (can be included as discretion of PI, if episodes are infrequent, nonmedicated, and no active problems at time of study) * Claustrophobia (at discretion of PI) Additional exclusion criteria for Lorazepam arm * Acute narrow-angle glaucoma * Compromised respiratory function (e.g. sleep apnea and chronic obstructive pulmonary disease) * Impaired renal and hepatic function

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