HealthyNCT01566539
Biological Basis of Individual Variation in Social Cooperation
A study testing Intranasal Oxytocin (OT) 24 IU, Intranasal Vasopressin (AVP) and Intranasal Vasopressin (AVP) 40 IU in people with Healthy, run by Emory University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Intranasal Oxytocin (OT) 24 IU, Intranasal Vasopressin (AVP) and Intranasal Vasopressin (AVP) 40 IU
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 707 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Nov 2016
- Phase
- Interventional
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Hospital
Atlanta, Georgia, 30307
Emory University 1462 Clifton Rd
Atlanta, Georgia, 30322
About this study
Official title: The Biological Basis of Individual Variation in Social Cooperation
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.
Read the detailed description
There are several objective to the study.
Objective 1: In this double-blind, placebo-controlled, pharmaco- fMRI study, men and women will be randomized to treatment with either 24 IU intranasal OT, 20 IU intranasal AVP, or placebo (PL). Approximately 40 minutes later, brain function will be imaged with fMRI as participants play an iterated Prisoner's Dilemma game with same-sex partners. The resulting data will be analyzed to investigate OT and AVP effects on cooperative behavior and the neural response to cooperative social interactions.
In addition to this cross-sectional design, a subset of participants will return on a second day for a within-subject study.
Objective 2: Men and healthy women will be randomized to treatment with either 40 IU intranasal AVP or a saline placebo approximately 30 minutes before their brain function is measured with fMRI as they view same and other-sex faces. All subjects will be scanned a second time several days later with no treatment to evaluate the persistence of AVP effects over time. The resulting data will be analyzed to investigate AVP effects on subjective evaluations and neural responses to viewing same and opposite sex faces.
Objective 3: Healthy men and healthy women will receive either 24IU intranasal OT or PL approximately 40 minutes before their brain function is measured with fMRI as they view animations of geometric shapes depicting either random movement or social interactions such as playing, chasing, fighting. All participants will receive PL on scan 1 and will be randomized to either 24IU intranasal OT or PL on scan 2. The resulting data will be analyzed to investigate OT effects on subjective evaluations and neural responses to the animations.
- Conditions
- Healthy
- Being tested
- Intranasal Oxytocin (OT) 24 IU, Intranasal Vasopressin (AVP), Intranasal Placebo, Intranasal Vasopressin (AVP) 40 IU, Lorazepam
- Keywords
- Social cooperation, Oxytocin, Vasopressin, Prisoner's Dilemma game, Empathy, fMRI
- Medical subject headings
- Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal Oxytocin (OT) 24 IUDrug
Also called Oxytocin: Syntocinon Nasal Spray
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)Drug
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 PlaceboDrug
Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.
Intranasal Vasopressin (AVP) 40 IUDrug
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.
LorazepamDrug
Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers - Intranasal Vasopressin (AVP) | Experimental | The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task. Receives: Drug: Intranasal Vasopressin (AVP) |
| Healthy Volunteers - Intranasal Oxytocin (OT) | Experimental | The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task. Receives: Drug: Intranasal Oxytocin (OT) 24 IU |
| Healthy Volunteers - Intranasal Placebo | Placebo comparator | The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task. Receives: Drug: Intranasal Placebo |
| Within Subject Group | Experimental | 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. Receives: Drug: Intranasal Oxytocin (OT) 24 IU; Drug: Intranasal Vasopressin (AVP); Drug: Intranasal Placebo |
| Faces Task - Vasopressin (AVP) | Experimental | Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning. Receives: Drug: Intranasal Vasopressin (AVP) 40 IU |
| Faces Task - Placebo | Placebo comparator | Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning. Receives: Drug: Intranasal Placebo |
| Empathy Task - Oxytocin (OT) | Experimental | 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. Receives: Drug: Intranasal Oxytocin (OT) 24 IU; Drug: Intranasal Placebo |
| Empathy Task - Placebo | Placebo comparator | 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. Receives: Drug: Intranasal Placebo |
| Anxious and Depressed Subjects - OT | Experimental | 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. Receives: Drug: Intranasal Oxytocin (OT) 24 IU |
| Anxious and Depressed Subjects - Placebo | Placebo comparator | 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. Receives: Drug: Intranasal Placebo |
| Healthy Volunteers - Lorazepam | Experimental | 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. Receives: Drug: Lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men
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.
Measured: Visit 1 (40-100 Minutes Post-Intervention)
Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Women
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.
Measured: Visit 1 (40-100 Minutes Post-Intervention)
Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Men
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.
Measured: Visit 1 (40-100 Minutes Post-Intervention)
Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Women
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.
Measured: Visit 1 (40-100 Minutes Post-Intervention)
Within Subject Group: Mean Percent Signal Change in Left Caudate Nucleus in Men and Women
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.
Measured: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)
Secondary outcomes (12)
Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Men During the Prisoners Dilemma Game
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.
Measured: Visit 1 (40-100 Minutes Post-Intervention)
Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Women During the Prisoners Dilemma Game
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.
Measured: Visit 1 (40-100 Minutes Post-Intervention)
Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Male During the Prisoners Dilemma Game
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.
Measured: 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 Female During the Prisoners Dilemma Game
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.
Measured: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)
Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Men
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.
Measured: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)
Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Women
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.
Measured: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)
Faces Task Groups: Mean Approachability Rating of Faces in Men
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.
Measured: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)
Faces Task Group: Mean Approachability Rating of Faces in Women
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.
Measured: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)
Faces Task Groups: Mean Attractiveness Rating of Faces in Men
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.
Measured: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)
Faces Task Groups: Mean Attractiveness Rating of Faces in Women
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.
Measured: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)
Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Women
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.
Measured: Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month)
Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Men
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.
Measured: Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startApr 2008
- Primary completionNov 2016
- Study completionNov 2016
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 (6)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 707 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), John Templeton Foundation
- Responsible party
- Principal investigator, James K. Rilling, PhD, Emory University
- Investigators
- James K Rilling, Ph.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566539
- Sponsor's protocol ID
- IRB00007905
- Other IDs
- 1R01MH084068-01A1, MH087721-01A1
- Status last verified
- Sep 2017
- First submitted
- 26 Mar 2012
- Last updated
- 25 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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 15931222Fisher H, Aron A, Brown LL. Romantic love: an fMRI study of a neural mechanism for mate choice. J Comp Neurol. 2005 Dec 5;493(1):58-62. doi: 10.1002/cne.20772.
PubMed 16255001Thompson RR, George K, Walton JC, Orr SP, Benson J. Sex-specific influences of vasopressin on human social communication. Proc Natl Acad Sci U S A. 2006 May 16;103(20):7889-94. doi: 10.1073/pnas.0600406103. Epub 2006 May 8.
PubMed 16682649Vrticka P, Andersson F, Sander D, Vuilleumier P. Memory for friends or foes: the social context of past encounters with faces modulates their subsequent neural traces in the brain. Soc Neurosci. 2009;4(5):384-401. doi: 10.1080/17470910902941793. Epub 2009 Jul 27.
PubMed 19637101Singer T, Kiebel SJ, Winston JS, Dolan RJ, Frith CD. Brain responses to the acquired moral status of faces. Neuron. 2004 Feb 19;41(4):653-62. doi: 10.1016/s0896-6273(04)00014-5.
PubMed 14980212Guroglu B, Haselager GJ, van Lieshout CF, Takashima A, Rijpkema M, Fernandez G. Why are friends special? Implementing a social interaction simulation task to probe the neural correlates of friendship. Neuroimage. 2008 Jan 15;39(2):903-10. doi: 10.1016/j.neuroimage.2007.09.007. Epub 2007 Sep 15.
PubMed 17964185
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biological Basis of Individual Variation in Social Cooperation
- ClinicalTrials.gov ID
- NCT01566539
- Acronym / sponsor ID
- IRB00007905
- Conditions
- Healthy
- Keywords
- Social cooperation, Oxytocin, Vasopressin, Prisoner's Dilemma game, Empathy, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 707 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), John Templeton Foundation
- Study start
- Apr 2008
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Posted 25 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are several objective to the study.
Objective 1: In this double-blind, placebo-controlled, pharmaco- fMRI study, men and women will be randomized to treatment with either 24 IU intranasal OT, 20 IU intranasal AVP, or placebo (PL). Approximately 40 minutes later, brain function will be imaged with fMRI as participants play an iterated Prisoner's Dilemma game with same-sex partners. The resulting data will be analyzed to investigate OT and AVP effects on cooperative behavior and the neural response to cooperative social interactions.
In addition to this cross-sectional design, a subset of participants will return on a second day for a within-subject study.
Objective 2: Men and healthy women will be randomized to treatment with either 40 IU intranasal AVP or a saline placebo approximately 30 minutes before their brain function is measured with fMRI as they view same and other-sex faces. All subjects will be scanned a second time several days later with no treatment to evaluate the persistence of AVP effects over time. The resulting data will be analyzed to investigate AVP effects on subjective evaluations and neural responses to viewing same and opposite sex faces.
Objective 3: Healthy men and healthy women will receive either 24IU intranasal OT or PL approximately 40 minutes before their brain function is measured with fMRI as they view animations of geometric shapes depicting either random movement or social interactions such as playing, chasing, fighting. All participants will receive PL on scan 1 and will be randomized to either 24IU intranasal OT or PL on scan 2. The resulting data will be analyzed to investigate OT effects on subjective evaluations and neural responses to the animations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers - Intranasal Vasopressin (AVP) | Experimental | Drug: Intranasal Vasopressin (AVP)The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task. |
| Healthy Volunteers - Intranasal Oxytocin (OT) | Experimental | Drug: Intranasal Oxytocin (OT) 24 IUThe OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task. |
| Healthy Volunteers - Intranasal Placebo | Placebo comparator | Drug: Intranasal PlaceboThe placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task. |
| Within Subject Group | Experimental | Drug: Intranasal Oxytocin (OT) 24 IU, Drug: Intranasal Vasopressin (AVP), Drug: Intranasal PlaceboSome 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. |
| Faces Task - Vasopressin (AVP) | Experimental | Drug: Intranasal Vasopressin (AVP) 40 IUHealthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning. |
| Faces Task - Placebo | Placebo comparator | Drug: Intranasal PlaceboHealthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning. |
| Empathy Task - Oxytocin (OT) | Experimental | Drug: Intranasal Oxytocin (OT) 24 IU, Drug: Intranasal PlaceboHealthy 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. |
| Empathy Task - Placebo | Placebo comparator | Drug: Intranasal 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. |
| Anxious and Depressed Subjects - OT | Experimental | Drug: Intranasal Oxytocin (OT) 24 IUDepressed 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. |
| Anxious and Depressed Subjects - Placebo | Placebo comparator | Drug: Intranasal PlaceboDepressed 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. |
| Healthy Volunteers - Lorazepam | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- Pregnancy, recent birth, or breastfeeding
- History of seizures
- Neurological Disorder
- Current psychiatric disorder
- Previous psychiatric disorder (can be included as discretion of PI)
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 |
|---|---|---|
| Intranasal Oxytocin (OT) 24 IUAlso: Oxytocin: Syntocinon Nasal SprayParticipants 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. | Drug | Anxious and Depressed Subjects - OT, Empathy Task - Oxytocin (OT), Healthy Volunteers - Intranasal Oxytocin (OT), Within Subject Group |
| 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). | Drug | Healthy Volunteers - Intranasal Vasopressin (AVP), Within Subject Group |
| Intranasal PlaceboParticipants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total. | Drug | Anxious and Depressed Subjects - Placebo, Empathy Task - Oxytocin (OT), Empathy Task - Placebo, Faces Task - Placebo, Healthy Volunteers - Intranasal Placebo, Within Subject Group |
| Intranasal Vasopressin (AVP) 40 IUParticipants 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. | Drug | Faces Task - Vasopressin (AVP) |
| LorazepamSubjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan. | Drug | Healthy Volunteers - Lorazepam |
Primary outcome
Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men
Time frame: Visit 1 (40-100 Minutes Post-Intervention)
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.
Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Women
Time frame: Visit 1 (40-100 Minutes Post-Intervention)
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.
Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Men
Time frame: Visit 1 (40-100 Minutes Post-Intervention)
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.
Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Women
Time frame: Visit 1 (40-100 Minutes Post-Intervention)
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.
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)
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.
12 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 16255001Fisher H, Aron A, Brown LL. Romantic love: an fMRI study of a neural mechanism for mate choice. J Comp Neurol. 2005 Dec 5;493(1):58-62. doi: 10.1002/cne.20772.
- Background: PubMed 16682649Thompson RR, George K, Walton JC, Orr SP, Benson J. Sex-specific influences of vasopressin on human social communication. Proc Natl Acad Sci U S A. 2006 May 16;103(20):7889-94. doi: 10.1073/pnas.0600406103. Epub 2006 May 8.
- Background: PubMed 19637101Vrticka P, Andersson F, Sander D, Vuilleumier P. Memory for friends or foes: the social context of past encounters with faces modulates their subsequent neural traces in the brain. Soc Neurosci. 2009;4(5):384-401. doi: 10.1080/17470910902941793. Epub 2009 Jul 27.
- Background: PubMed 14980212Singer T, Kiebel SJ, Winston JS, Dolan RJ, Frith CD. Brain responses to the acquired moral status of faces. Neuron. 2004 Feb 19;41(4):653-62. doi: 10.1016/s0896-6273(04)00014-5.
- Background: PubMed 17964185Guroglu B, Haselager GJ, van Lieshout CF, Takashima A, Rijpkema M, Fernandez G. Why are friends special? Implementing a social interaction simulation task to probe the neural correlates of friendship. Neuroimage. 2008 Jan 15;39(2):903-10. doi: 10.1016/j.neuroimage.2007.09.007. Epub 2007 Sep 15.
- Related InfoLink provided by the sponsor.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
James K Rilling, Ph.D. principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intranasal Oxytocin (OT) 24 IU, Intranasal Vasopressin (AVP) and Intranasal Vasopressin (AVP) 40 IU in people with Healthy, run by Emory University at 2 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 4 inclusion and 21 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 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 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?
Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men (time frame: Visit 1 (40-100 Minutes Post-Intervention)). The study lists 5 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 NCT01566539, which also lists 6 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 25 Sep 2017.