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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH084068-01A1 | U.S. NIH Grant/Contract | View source | |
| MH087721-01A1 | Other Identifier | NIMH |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| John Templeton Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers - Intranasal Vasopressin (AVP) | Experimental | The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task. |
|
| Healthy Volunteers - Intranasal Oxytocin (OT) | Experimental | The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task. |
|
| Healthy Volunteers - Intranasal Placebo | Placebo Comparator | The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Oxytocin (OT) 24 IU | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 1 (40-100 Minutes Post-Intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Healthy Volunteers Groups: Mean Vasopressin (AVP) Plasma Level | Peripheral levels of AVP will be assessed via assay of plasma collected. | Visit 1 (Up to 3 Hours) |
| Healthy Volunteers Groups: Mean Oxytocin (OT) Plasma Level |
Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criteria for Lorazepam arm
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| Name | Affiliation | Role |
|---|---|---|
| James K Rilling, Ph.D. | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30307 | United States | ||
| Emory University 1462 Clifton Rd |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15931222 | Background | 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. | |
| 16255001 | Background | Fisher 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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The study team did not recruit any participants for the "Anxious and Depressed Subjects - OT", or "Anxious and Depressed Subjects - Placebo" arms.Therefore, these arms have been removed from the record.
A total of 707 signed the consent form, 449 started the main study period.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| FG002 | Healthy Volunteers - Intranasal Placebo | The 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. |
| FG003 | 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. 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 pH |
| FG004 | 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. |
| FG005 | Faces Task - Placebo | Healthy 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. |
| FG006 | 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. |
| FG007 | 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. 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. |
| FG008 | 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. Lorazepam: Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study Period |
| |||||||||||||
| Within Subject Group |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis was completed in the Healthy Volunteers - Intranasal Oxytocin (OT) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis. | Posted | Mean | Standard Error | percent signal change | Visit 1 (40-100 Minutes Post-Intervention) |
|
Adverse event were collected throughout the duration of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| claustrophobia | Psychiatric disorders | Systematic Assessment | participants have claustrophobia and cannot enter a MRI scanner |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Rilling | Emory University | 404-727-3062 | jrillin@emory.edu |
Not provided
| ID | Term |
|---|---|
| D003919 | Diabetes Insipidus |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
|
| 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 Placebo | Drug | 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 IU | Drug | 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. |
|
| Lorazepam | Drug | Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan. |
|
| Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks) |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month) |
Peripheral levels of OT will be assessed via assay of plasma collected.
| Visit 1 (Up to 3 Hours) |
| Healthy Volunteers Groups: Mean Testosterone Plasma Level | Peripherals levels of testosterone will be assessed via assay of plasma collected. | Visit 1 (Up to 3 Hours) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| 16682649 | Background | Thompson 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. |
| 19637101 | Background | Vrticka 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. |
| 14980212 | Background | Singer 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. |
| 17964185 | Background | Guroglu 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 |
| 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. |
| BG002 | Healthy Volunteers - Intranasal Placebo | The 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. |
| BG003 | 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. |
| BG004 | Faces Task - Placebo | Healthy 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. |
| BG005 | 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. |
| BG006 | 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. 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. |
| BG007 | 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. Lorazepam: Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan. |
| BG008 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Healthy Volunteers - Intranasal Placebo | The 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. |
|
|
| Primary | 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. | Analysis was completed in the Healthy Volunteers - Intranasal Oxytocin (OT) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis. | Posted | Mean | Standard Error | percent signal change | Visit 1 (40-100 Minutes Post-Intervention) |
|
|
|
| Primary | 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. | Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis. | Posted | Mean | Standard Error | percent signal change | Visit 1 (40-100 Minutes Post-Intervention) |
|
|
|
| Primary | 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. | Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis. | Posted | Mean | Standard Error | percent signal change | Visit 1 (40-100 Minutes Post-Intervention) |
|
|
|
| Primary | 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. | Analysis was completed for the within subject group per protocol. Subjects with excessive motion during scanning were excluded from the analysis. | Posted | Mean | Standard Deviation | percent signal change | Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks) |
|
|
|
| Secondary | 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. | Analysis was completed for the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with missing data were excluded from the analysis. | Posted | Mean | Standard Error | number of choices | Visit 1 (40-100 Minutes Post-Intervention) |
|
|
|
| Secondary | 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. | Analysis was completed for the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with missing data were excluded from the analysis. | Posted | Mean | Standard Error | number of choices | Visit 1 (40-100 Minutes Post-Intervention) |
|
|
|
| Secondary | 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. | Analysis was completed for the Within Subject Group per protocol. Subjects with missing data were excluded from the analysis. The difference between OT and PL visits is reported here (OT-PL). | Posted | Mean | Standard Deviation | number of choices | Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks) |
|
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| Secondary | 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. | Analysis was completed for the Within Subject Group per protocol. Subjects with missing data were excluded from the analysis. | Posted | Mean | Standard Deviation | number of choices | Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks) |
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| Secondary | 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. | Analysis was completed for the Faces Task - Vasopressin (AVP) and Faces Task - Placebo groups per protocol. Subjects with missing data were excluded from the analysis. | Posted | Mean | Standard Deviation | percent signal change | Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days) |
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| Secondary | 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. | Analysis was completed for the Faces Task - Vasopressin (AVP) and Faces Task - Placebo groups per protocol. Subjects with missing data were excluded from the analysis. | Posted | Mean | Standard Deviation | percent signal change | Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days) |
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| Secondary | 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. | Data was collected per protocol in the AVP and placebo faces groups. | Posted | Mean | Standard Deviation | units on a scale | Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days) |
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| Secondary | 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. | Data was collected per protocol in the AVP and placebo faces groups. | Posted | Mean | Standard Deviation | units on a scale | Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days) |
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| Secondary | 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. | Data was collected per protocol in the AVP and placebo faces groups. | Posted | Mean | Standard Deviation | units on a scale | Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days) |
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| Secondary | 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. | Data was collected per protocol in the AVP and placebo faces groups. | Posted | Mean | Standard Deviation | units on a scale | Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days) |
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| Secondary | 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. | Data was collected per protocol in the OT and placebo empathy task groups. | Posted | Mean | Standard Deviation | percent signal change | Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month) |
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| Secondary | 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. | Data was collected per protocol in the OT and placebo empathy task groups. | Posted | Mean | Standard Deviation | percent signal change | Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month) |
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| Other Pre-specified | Healthy Volunteers Groups: Mean Vasopressin (AVP) Plasma Level | Peripheral levels of AVP will be assessed via assay of plasma collected. | Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with unreliable or missing data were excluded from the analysis. | Posted | Mean | Standard Error | pg/ml | Visit 1 (Up to 3 Hours) |
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| Other Pre-specified | Healthy Volunteers Groups: Mean Oxytocin (OT) Plasma Level | Peripheral levels of OT will be assessed via assay of plasma collected. | Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with unreliable or missing data were excluded from the analysis. | Posted | Mean | Standard Error | pg/ml | Visit 1 (Up to 3 Hours) |
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| Other Pre-specified | Healthy Volunteers Groups: Mean Testosterone Plasma Level | Peripherals levels of testosterone will be assessed via assay of plasma collected. | Analysis was completed in the first batch of data collection from Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Due to the lack of funds, no subsequent analysis has been done on the samples collected. | Posted | Mean | Standard Deviation | ng/dl | Visit 1 (Up to 3 Hours) |
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| 0 |
| 101 |
| 0 |
| 101 |
| 3 |
| 101 |
| EG001 | 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 | 100 | 0 | 100 | 4 | 100 |
| EG002 | Healthy Volunteers - Intranasal Placebo | The 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 | 104 | 0 | 104 | 12 | 104 |
| EG003 | 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. 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 pH | 0 | 156 | 0 | 156 | 0 | 156 |
| EG004 | 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 | 40 | 0 | 40 | 0 | 40 |
| EG005 | Faces Task - Placebo | Healthy 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 | 43 | 0 | 43 | 1 | 43 |
| EG006 | 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 | 30 | 0 | 30 | 0 | 30 |
| EG007 | 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. 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 | 30 | 0 | 30 | 0 | 30 |
| EG008 | 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. Lorazepam: Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan. | 0 | 1 | 0 | 1 | 0 | 1 |
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| fever | General disorders | Systematic Assessment | Participant came in with a fever and was scheduled for later date. No procedures were done to the participant. |
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| high blood pressure or heart rate post-drug administration | Vascular disorders | Systematic Assessment | Subjects experience high blood pressure (above 140/90) or heart rate (above 100 bpm) post drug administration. Per protocol, subjects rested for 5-10 minutes and blood pressure and heart rate was retaken. They returned normal. Study proceeded. |
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| felt faint after blood draw | General disorders | Systematic Assessment | subject felt faint after first blood draw. After resting, subject recovered and the study continued. |
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| nose bleed | General disorders | Systematic Assessment | subject experience nose bleed prior to drug administration, probably due to dry weather. |
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| nausea | General disorders | Systematic Assessment | Subject experience nausea after drug administration.The subject believed it was due to hunger. Study physician was contacted and subject was provided some food. Once fed, the nausea subsided. He reported no side-effects. |
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Not provided
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
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| Placebo treatment in women |
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| viewing same-sex faces scan 2 |
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| viewing other-sex faces scan 2 |
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| viewing same-sex faces scan 2 |
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| viewing other-sex faces scan 2 |
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| viewing same-sex faces scan 2 |
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| viewing other-sex faces scan 2 |
|
| viewing same-sex faces scan 2 |
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| viewing other-sex faces scan 2 |
|