Trial Outcomes & Findings for Biological Basis of Individual Variation in Social Cooperation (NCT NCT01566539)
NCT ID: NCT01566539
Last Updated: 2017-09-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
707 participants
Primary outcome timeframe
Visit 1 (40-100 Minutes Post-Intervention)
Results posted on
2017-09-25
Participant Flow
A total of 707 signed the consent form, 449 started the main study period.
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.
Participant milestones
| Measure |
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).
|
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.
|
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.
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Main Study Period
STARTED
|
101
|
100
|
104
|
0
|
40
|
43
|
30
|
30
|
1
|
|
Main Study Period
COMPLETED
|
100
|
100
|
104
|
0
|
40
|
40
|
30
|
30
|
1
|
|
Main Study Period
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Within Subject Group
STARTED
|
0
|
0
|
0
|
156
|
0
|
0
|
0
|
0
|
0
|
|
Within Subject Group
COMPLETED
|
0
|
0
|
0
|
153
|
0
|
0
|
0
|
0
|
0
|
|
Within Subject Group
NOT COMPLETED
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Biological Basis of Individual Variation in Social Cooperation
Baseline characteristics by cohort
| Measure |
Healthy Volunteers - Intranasal Vasopressin (AVP)
n=101 Participants
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).
|
Healthy Volunteers - Intranasal Oxytocin (OT)
n=100 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=104 Participants
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.
|
Faces Task - Vasopressin (AVP)
n=40 Participants
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.
|
Faces Task - Placebo
n=43 Participants
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.
|
Empathy Task - Oxytocin (OT)
n=30 Participants
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.
|
Empathy Task - Placebo
n=30 Participants
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.
|
Healthy Volunteers - Lorazepam
n=1 Participants
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.
|
Total
n=449 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
101 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
449 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
223 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
226 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
101 participants
n=5 Participants
|
100 participants
n=7 Participants
|
104 participants
n=5 Participants
|
40 participants
n=4 Participants
|
43 participants
n=21 Participants
|
30 participants
n=10 Participants
|
30 participants
n=115 Participants
|
1 participants
n=24 Participants
|
449 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (40-100 Minutes Post-Intervention)Population: 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.
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.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=43 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=48 Participants
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.
|
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.
|
|---|---|---|---|
|
Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men
|
0.21 percent signal change
Standard Error 0.03
|
0.07 percent signal change
Standard Error 0.02
|
—
|
PRIMARY outcome
Timeframe: Visit 1 (40-100 Minutes Post-Intervention)Population: 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.
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.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=47 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=46 Participants
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.
|
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.
|
|---|---|---|---|
|
Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Women
|
0.04 percent signal change
Standard Error 0.02
|
0.15 percent signal change
Standard Error 0.02
|
—
|
PRIMARY outcome
Timeframe: Visit 1 (40-100 Minutes Post-Intervention)Population: 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.
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.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=44 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=48 Participants
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.
|
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.
|
|---|---|---|---|
|
Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Men
|
0.13 percent signal change
Standard Error 0.02
|
-0.02 percent signal change
Standard Error 0.02
|
—
|
PRIMARY outcome
Timeframe: Visit 1 (40-100 Minutes Post-Intervention)Population: 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.
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.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=49 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=46 Participants
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.
|
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.
|
|---|---|---|---|
|
Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Women
|
-0.05 percent signal change
Standard Error 0.03
|
0.10 percent signal change
Standard Error 0.03
|
—
|
PRIMARY outcome
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)Population: Analysis was completed for the within subject group per protocol. Subjects with excessive motion during scanning were excluded from the analysis.
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.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=57 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
Within Subject Group: Mean Percent Signal Change in Left Caudate Nucleus in Men and Women
Oxytocin treatment in men
|
0.21 percent signal change
Standard Deviation 0.19
|
—
|
—
|
|
Within Subject Group: Mean Percent Signal Change in Left Caudate Nucleus in Men and Women
Placebo treatment in men
|
0.19 percent signal change
Standard Deviation 0.29
|
—
|
—
|
|
Within Subject Group: Mean Percent Signal Change in Left Caudate Nucleus in Men and Women
Oxytocin treatment in women
|
0.06 percent signal change
Standard Deviation 0.21
|
—
|
—
|
|
Within Subject Group: Mean Percent Signal Change in Left Caudate Nucleus in Men and Women
Placebo treatment in women
|
0.10 percent signal change
Standard Deviation 0.18
|
—
|
—
|
SECONDARY outcome
Timeframe: Visit 1 (40-100 Minutes Post-Intervention)Population: 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.
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.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=49 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=50 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=53 Participants
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.
|
|---|---|---|---|
|
Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Men During the Prisoners Dilemma Game
|
15.71 number of choices
Standard Error 0.98
|
16.18 number of choices
Standard Error 1.01
|
17.68 number of choices
Standard Error 0.93
|
SECONDARY outcome
Timeframe: Visit 1 (40-100 Minutes Post-Intervention)Population: 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.
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.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=51 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=50 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=50 Participants
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.
|
|---|---|---|---|
|
Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Women During the Prisoners Dilemma Game
|
15.84 number of choices
Standard Error 0.76
|
18.14 number of choices
Standard Error 1.03
|
16.92 number of choices
Standard Error 0.98
|
SECONDARY outcome
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)Population: 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).
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.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=29 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Male During the Prisoners Dilemma Game
|
-1.10 number of choices
Standard Deviation 5.21
|
—
|
—
|
SECONDARY outcome
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)Population: Analysis was completed for the Within Subject Group per protocol. Subjects with missing data were excluded from the analysis.
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.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=30 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Female During the Prisoners Dilemma Game
Placebo treatment
|
15.53 number of choices
Standard Deviation 6.70
|
—
|
—
|
|
Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Female During the Prisoners Dilemma Game
Oxytocin treatment
|
16.13 number of choices
Standard Deviation 6.87
|
—
|
—
|
SECONDARY outcome
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)Population: 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.
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.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=20 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=20 Participants
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.
|
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.
|
|---|---|---|---|
|
Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Men
viewing same-sex faces
|
0.03 percent signal change
Standard Deviation 0.30
|
-0.14 percent signal change
Standard Deviation 0.22
|
—
|
|
Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Men
viewing other-sex faces
|
0.14 percent signal change
Standard Deviation 0.33
|
-0.13 percent signal change
Standard Deviation 0.30
|
—
|
SECONDARY outcome
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)Population: 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.
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.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=20 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=19 Participants
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.
|
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.
|
|---|---|---|---|
|
Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Women
viewing same-sex faces
|
-0.08 percent signal change
Standard Deviation 0.31
|
0.12 percent signal change
Standard Deviation 0.22
|
—
|
|
Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Women
viewing other-sex faces
|
0.003 percent signal change
Standard Deviation 0.16
|
0.13 percent signal change
Standard Deviation 0.22
|
—
|
SECONDARY outcome
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)Population: Data was collected per protocol in the AVP and placebo faces groups.
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.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=20 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=20 Participants
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.
|
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.
|
|---|---|---|---|
|
Faces Task Groups: Mean Approachability Rating of Faces in Men
viewing same-sex faces scan 1
|
0.31 units on a scale
Standard Deviation 0.96
|
-0.06 units on a scale
Standard Deviation 0.96
|
—
|
|
Faces Task Groups: Mean Approachability Rating of Faces in Men
viewing other-sex faces scan 1
|
1.00 units on a scale
Standard Deviation 1.09
|
0.81 units on a scale
Standard Deviation 0.92
|
—
|
|
Faces Task Groups: Mean Approachability Rating of Faces in Men
viewing same-sex faces scan 2
|
0.78 units on a scale
Standard Deviation 0.88
|
0.25 units on a scale
Standard Deviation 0.99
|
—
|
|
Faces Task Groups: Mean Approachability Rating of Faces in Men
viewing other-sex faces scan 2
|
1.19 units on a scale
Standard Deviation 1.04
|
0.89 units on a scale
Standard Deviation 0.98
|
—
|
SECONDARY outcome
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)Population: Data was collected per protocol in the AVP and placebo faces groups.
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.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=20 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=20 Participants
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.
|
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.
|
|---|---|---|---|
|
Faces Task Group: Mean Approachability Rating of Faces in Women
viewing same-sex faces scan 1
|
0.37 units on a scale
Standard Deviation 0.57
|
0.21 units on a scale
Standard Deviation 0.86
|
—
|
|
Faces Task Group: Mean Approachability Rating of Faces in Women
viewing other-sex faces scan 1
|
-0.04 units on a scale
Standard Deviation 0.83
|
0.28 units on a scale
Standard Deviation 0.61
|
—
|
|
Faces Task Group: Mean Approachability Rating of Faces in Women
viewing same-sex faces scan 2
|
0.37 units on a scale
Standard Deviation 0.57
|
0.23 units on a scale
Standard Deviation 0.88
|
—
|
|
Faces Task Group: Mean Approachability Rating of Faces in Women
viewing other-sex faces scan 2
|
0.12 units on a scale
Standard Deviation 0.66
|
0.22 units on a scale
Standard Deviation 0.63
|
—
|
SECONDARY outcome
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)Population: Data was collected per protocol in the AVP and placebo faces groups.
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.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=20 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=20 Participants
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.
|
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.
|
|---|---|---|---|
|
Faces Task Groups: Mean Attractiveness Rating of Faces in Men
viewing same-sex faces scan 1
|
0.35 units on a scale
Standard Deviation 0.78
|
-0.06 units on a scale
Standard Deviation 0.77
|
—
|
|
Faces Task Groups: Mean Attractiveness Rating of Faces in Men
viewing other-sex faces scan 1
|
1.79 units on a scale
Standard Deviation 0.58
|
1.60 units on a scale
Standard Deviation 0.46
|
—
|
|
Faces Task Groups: Mean Attractiveness Rating of Faces in Men
viewing same-sex faces scan 2
|
0.52 units on a scale
Standard Deviation 0.86
|
-0.08 units on a scale
Standard Deviation 0.79
|
—
|
|
Faces Task Groups: Mean Attractiveness Rating of Faces in Men
viewing other-sex faces scan 2
|
1.70 units on a scale
Standard Deviation 0.69
|
1.43 units on a scale
Standard Deviation 0.64
|
—
|
SECONDARY outcome
Timeframe: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)Population: Data was collected per protocol in the AVP and placebo faces groups.
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.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=20 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=20 Participants
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.
|
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.
|
|---|---|---|---|
|
Faces Task Groups: Mean Attractiveness Rating of Faces in Women
viewing same-sex faces scan 1
|
1.56 units on a scale
Standard Deviation 0.54
|
1.02 units on a scale
Standard Deviation 0.80
|
—
|
|
Faces Task Groups: Mean Attractiveness Rating of Faces in Women
viewing other-sex faces scan 1
|
0.55 units on a scale
Standard Deviation 1.16
|
0.61 units on a scale
Standard Deviation 0.62
|
—
|
|
Faces Task Groups: Mean Attractiveness Rating of Faces in Women
viewing same-sex faces scan 2
|
1.29 units on a scale
Standard Deviation 0.68
|
0.82 units on a scale
Standard Deviation 0.92
|
—
|
|
Faces Task Groups: Mean Attractiveness Rating of Faces in Women
viewing other-sex faces scan 2
|
0.53 units on a scale
Standard Deviation 1.04
|
0.28 units on a scale
Standard Deviation 0.51
|
—
|
SECONDARY outcome
Timeframe: Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month)Population: Data was collected per protocol in the OT and placebo empathy task groups.
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.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=15 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=15 Participants
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.
|
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.
|
|---|---|---|---|
|
Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Women
|
-.910 percent signal change
Standard Deviation .417
|
-.377 percent signal change
Standard Deviation .656
|
—
|
SECONDARY outcome
Timeframe: Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month)Population: Data was collected per protocol in the OT and placebo empathy task groups.
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.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=15 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=15 Participants
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.
|
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.
|
|---|---|---|---|
|
Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Men
|
-.429 percent signal change
Standard Deviation .711
|
-.382 percent signal change
Standard Deviation 1.012
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (Up to 3 Hours)Population: 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.
Peripheral levels of AVP will be assessed via assay of plasma collected.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=27 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=27 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=36 Participants
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.
|
|---|---|---|---|
|
Healthy Volunteers Groups: Mean Vasopressin (AVP) Plasma Level
|
4.5 pg/ml
Standard Error 0.49
|
3.5 pg/ml
Standard Error 0.34
|
3.1 pg/ml
Standard Error 0.40
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (Up to 3 Hours)Population: 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.
Peripheral levels of OT will be assessed via assay of plasma collected.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=27 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=27 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=36 Participants
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.
|
|---|---|---|---|
|
Healthy Volunteers Groups: Mean Oxytocin (OT) Plasma Level
|
120.6 pg/ml
Standard Error 7.3
|
134.7 pg/ml
Standard Error 10.2
|
129.4 pg/ml
Standard Error 12.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (Up to 3 Hours)Population: 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.
Peripherals levels of testosterone will be assessed via assay of plasma collected.
Outcome measures
| Measure |
Healthy Volunteers - Intranasal Oxytocin (OT)
n=25 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=30 Participants
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.
|
Healthy Volunteers - Intranasal Placebo
n=31 Participants
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.
|
|---|---|---|---|
|
Healthy Volunteers Groups: Mean Testosterone Plasma Level
|
214.92 ng/dl
Standard Deviation 125.42
|
475.82 ng/dl
Standard Deviation 134.76
|
437.99 ng/dl
Standard Deviation 160.36
|
Adverse Events
Healthy Volunteers - Intranasal Vasopressin (AVP)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Healthy Volunteers - Intranasal Oxytocin (OT)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Healthy Volunteers - Intranasal Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Within Subject Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Faces Task - Vasopressin (AVP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Faces Task - Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Empathy Task - Oxytocin (OT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Empathy Task - Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Volunteers - Lorazepam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Volunteers - Intranasal Vasopressin (AVP)
n=101 participants at risk
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).
|
Healthy Volunteers - Intranasal Oxytocin (OT)
n=100 participants at risk
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.
|
Healthy Volunteers - Intranasal Placebo
n=104 participants at risk
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.
|
Within Subject Group
n=156 participants at risk
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
|
Faces Task - Vasopressin (AVP)
n=40 participants at risk
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.
|
Faces Task - Placebo
n=43 participants at risk
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.
|
Empathy Task - Oxytocin (OT)
n=30 participants at risk
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.
|
Empathy Task - Placebo
n=30 participants at risk
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.
|
Healthy Volunteers - Lorazepam
n=1 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
claustrophobia
|
0.00%
0/101 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/100 • Adverse event were collected throughout the duration of the study.
|
0.96%
1/104 • Number of events 1 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/156 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/40 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/43 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/30 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/30 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/1 • Adverse event were collected throughout the duration of the study.
|
|
General disorders
fever
|
0.00%
0/101 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/100 • Adverse event were collected throughout the duration of the study.
|
0.96%
1/104 • Number of events 1 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/156 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/40 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/43 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/30 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/30 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/1 • Adverse event were collected throughout the duration of the study.
|
|
Vascular disorders
high blood pressure or heart rate post-drug administration
|
3.0%
3/101 • Number of events 3 • Adverse event were collected throughout the duration of the study.
|
3.0%
3/100 • Number of events 3 • Adverse event were collected throughout the duration of the study.
|
8.7%
9/104 • Number of events 9 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/156 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/40 • Adverse event were collected throughout the duration of the study.
|
2.3%
1/43 • Number of events 1 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/30 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/30 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/1 • Adverse event were collected throughout the duration of the study.
|
|
General disorders
felt faint after blood draw
|
0.00%
0/101 • Adverse event were collected throughout the duration of the study.
|
1.0%
1/100 • Number of events 1 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/104 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/156 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/40 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/43 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/30 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/30 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/1 • Adverse event were collected throughout the duration of the study.
|
|
General disorders
nose bleed
|
0.99%
1/101 • Number of events 1 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/100 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/104 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/156 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/40 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/43 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/30 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/30 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/1 • Adverse event were collected throughout the duration of the study.
|
|
General disorders
nausea
|
0.00%
0/101 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/100 • Adverse event were collected throughout the duration of the study.
|
0.96%
1/104 • Number of events 1 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/156 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/40 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/43 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/30 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/30 • Adverse event were collected throughout the duration of the study.
|
0.00%
0/1 • Adverse event were collected throughout the duration of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place