Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men
| Group | Value (percent signal change) | Spread |
|---|---|---|
| Healthy Volunteers - Intranasal Oxytocin (OT) | 0.21 | 0.03 |
| Healthy Volunteers - Intranasal Placebo | 0.07 | 0.02 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
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.
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.
Outcomes the sponsor listed as primary.
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percent signal change) | Spread |
|---|---|---|
| Healthy Volunteers - Intranasal Oxytocin (OT) | 0.21 | 0.03 |
| Healthy Volunteers - Intranasal Placebo | 0.07 | 0.02 |
| Group | Value (percent signal change) | Spread |
|---|---|---|
| Healthy Volunteers - Intranasal Oxytocin (OT) | 0.04 | 0.02 |
| Healthy Volunteers - Intranasal Placebo | 0.15 | 0.02 |
| Group | Value (percent signal change) | Spread |
|---|---|---|
| Healthy Volunteers - Intranasal Vasopressin (AVP) | 0.13 | 0.02 |
| Healthy Volunteers - Intranasal Placebo | -0.02 | 0.02 |
| Group | Value (percent signal change) | Spread |
|---|---|---|
| Healthy Volunteers - Intranasal Vasopressin (AVP) | -0.05 | 0.03 |
| Healthy Volunteers - Intranasal Placebo | 0.10 | 0.03 |
| Group | Value (percent signal change) | Spread |
|---|---|---|
| Within Subject Group | 0.21 | 0.19 |
| Group | Value (number of choices) | Spread |
|---|---|---|
| Healthy Volunteers - Intranasal Vasopressin (AVP) | 15.71 | 0.98 |
| Healthy Volunteers - Intranasal Oxytocin (OT) | 16.18 | 1.01 |
| Healthy Volunteers - Intranasal Placebo | 17.68 | 0.93 |
| Group | Value (number of choices) | Spread |
|---|---|---|
| Healthy Volunteers - Intranasal Vasopressin (AVP) | 15.84 | 0.76 |
| Healthy Volunteers - Intranasal Oxytocin (OT) | 18.14 | 1.03 |
| Healthy Volunteers - Intranasal Placebo | 16.92 | 0.98 |
| Group | Value (number of choices) | Spread |
|---|---|---|
| Within Subject Group | -1.10 | 5.21 |
| Group | Deaths | Serious events | Other 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 / 101 | 0 / 101 | 3 / 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 / 100 | 0 / 100 | 4 / 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 / 104 | 0 / 104 | 12 / 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 pH | 0 / 156 | 0 / 156 | 0 / 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 / 40 | 0 / 40 | 0 / 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 / 43 | 0 / 43 | 1 / 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 / 30 | 0 / 30 | 0 / 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 / 30 | 0 / 30 | 0 / 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 / 1 | 0 / 1 | 0 / 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
Studies that cite this trial.
1 study on this page
Indexing hint: Clinical trial · 2005
Kosfeld et al. 2005Naturecited by 1,701
PMID 15931222DOI 10.1038/nature03701PUB-15931222
Who could join, as posted.
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