Trial Outcomes & Findings for Brain Dynamics of Oxytocin (NCT NCT01834261)
NCT ID: NCT01834261
Last Updated: 2017-03-17
Results Overview
This study recruited healthy adults. Subjects participated in an interactive neuroeconomic game, an iterative version of the classical "Trust Study." During this game, the subject ('investor') is first provided a sum of money (20 units). He then has the choice in terms of how much to invest in a fictional computer-generated trustee. The trustee then sends some percentage back to the subject ('investor'), and the game iterates over 20 trials (rounds). We computed the investment ratio as the ratio of the actual investment and the maximum allowed amount of 20 units, and analogously for the repayment ratio. Benevolent rounds were defined as those with increased investment ratios even after a decreased repayment ratio.
COMPLETED
PHASE1
51 participants
Immediately after completion of the study, for each subject.
2017-03-17
Participant Flow
Subjects were recruited at MIT and at MGH (distinct populations of participants). They randomly received Syntocinon or Placebo (40 IU) first. 51 subjects consented. 10 dropped out prior to receiving either drug. 21 at MIT and 20 at MGH completed at least one visit where they received either placebo/oxytocin. A total of 39 completed both.
All subjects who consented and passed history and physical examination received both oxytocin and placebo on different days. Exclusion criteria included any significant known medical conditions, metal in the body or claustrophobia, current use of psychotropic medications, BMI \> 30, pregnancy, breastfeeding, smoking, high blood pressure and anosmia.
Participant milestones
| Measure |
Oxytocin, Then Placebo
Healthy adult subjects who received oxytocin before their first scan, and placebo before their second scan.
|
Placebo, Then Oxytocin
Healthy adult subjects who received placebo before their first scan, and oxytocin before their second scan.
|
|---|---|---|
|
MIT fMRI and MEG Resting State Study
STARTED
|
11
|
10
|
|
MIT fMRI and MEG Resting State Study
COMPLETED
|
10
|
9
|
|
MIT fMRI and MEG Resting State Study
NOT COMPLETED
|
1
|
1
|
|
MGH Rest + Nueroeconomic Task fMRI
STARTED
|
10
|
10
|
|
MGH Rest + Nueroeconomic Task fMRI
COMPLETED
|
10
|
10
|
|
MGH Rest + Nueroeconomic Task fMRI
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brain Dynamics of Oxytocin
Baseline characteristics by cohort
| Measure |
Oxytocin, Then Placebo
n=20 Participants
Healthy adult subjects received several puffs of Syntocinon Nasal Spray, 40IU, once, prior to MRI and/or MEG scanning.
This group contains subjects who received oxytocin prior to first scan and placebo prior to second scan.
|
Placebo, Then Oxytocin
n=19 Participants
Healthy adult subjects received several puffs of Syntocinon Placebo Formulation, 40IU, once, prior to MRI and/or MEG scanning.
This group contains subjects who received placebo prior to first scan and oxytocin prior to second scan.
|
Total
n=39 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
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.1 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
28.1 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
27.6 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately after completion of the study, for each subject.Population: Healthy adult men.
This study recruited healthy adults. Subjects participated in an interactive neuroeconomic game, an iterative version of the classical "Trust Study." During this game, the subject ('investor') is first provided a sum of money (20 units). He then has the choice in terms of how much to invest in a fictional computer-generated trustee. The trustee then sends some percentage back to the subject ('investor'), and the game iterates over 20 trials (rounds). We computed the investment ratio as the ratio of the actual investment and the maximum allowed amount of 20 units, and analogously for the repayment ratio. Benevolent rounds were defined as those with increased investment ratios even after a decreased repayment ratio.
Outcome measures
| Measure |
Oxytocin
n=17 Participants
Subjects received oxytocin prior to the scan.
|
Placebo
n=17 Participants
Subjects received placebo prior to the scan.
|
|---|---|---|
|
Number of Benevolent Rounds
|
6.8 number of rounds
Standard Deviation 2.0
|
6.8 number of rounds
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Immediately after completion of the study, for each subject.Population: Healthy adult men.
This study recruited healthy adults. Subjects participated in an interactive neuroeconomic game, an iterative version of the classical "Trust Study." During this game, the subject ('investor') is first provided a sum of money (20 units). He then has the choice in terms of how much to invest in a fictional computer-generated trustee. The trustee then sends some percentage back to the subject ('investor'), and the game iterates over 20 trials (rounds). We computed the investment ratio as the ratio of the actual investment and the maximum allowed amount of 20 units, and analogously for the repayment ratio. Malevolent rounds were defined as those with decreased investment ratios even after an increased repayment ratio.
Outcome measures
| Measure |
Oxytocin
n=17 Participants
Subjects received oxytocin prior to the scan.
|
Placebo
n=17 Participants
Subjects received placebo prior to the scan.
|
|---|---|---|
|
Number of Malevolent Rounds
|
2.8 number of rounds
Standard Deviation 1.5
|
3.0 number of rounds
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Within two weeks of enrollment completion.Population: Healthy adult men (17 subjects completed the task fMRI (Trust Study) at MGH, remaining 3 subjects at MGH did not complete the task). The values reported for connections strengths below (0.45 and 0.18) are from the Bayesian Parameter Averaging. The measure of precision is the associated posterior probability, which is 1 for both.
During functional scans, subjects participated in an interactive neuroeconomic game, an iterative version of the classical "Trust Study." Subjects participated in an interactive neuroeconomic game, an iterative version of the classical "Trust Study." During this game, the subject ('investor') is first provided a sum of money (20 units). He then has the choice in terms of how much to invest in a fictional computer-generated trustee. The trustee then sends some percentage back to the subject ('investor'), and the game iterates over 20 trials (rounds). Using Dynamical Causal Modeling (DCM) we modeled the dynamic interaction between amygdala (AMY), nucleus accumbens (NAcc) and the orbitofrontal cortex (OFC). We observed altered connectivity strength between AMY and OFC under OT as compared to PL conditions.
Outcome measures
| Measure |
Oxytocin
n=17 Participants
Subjects received oxytocin prior to the scan.
|
Placebo
n=17 Participants
Subjects received placebo prior to the scan.
|
|---|---|---|
|
Functional Connectivity Between OFC and AMY
|
0.45 Hz
Standard Deviation NA
The value reported for connections strength (0.45 ) is from the Bayesian Parameter Averaging. The measure of precision is the associated posterior probability, which, in this case, is 1.
|
0.18 Hz
Standard Deviation NA
The value reported for connections strength (0.18) is from the Bayesian Parameter Averaging. The measure of precision is the associated posterior probability, which, in this case, is 1.
|
Adverse Events
Oxytocin, Then Placebo
Placebo, Then Oxytocin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lilianne Mujica Parodi, PhD / Study Principal Investigator
Stony Brook University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place