Trial Outcomes & Findings for Deciphering the Role of Oxytocin in Motivation: an fMRI Study (NCT NCT01722071)
NCT ID: NCT01722071
Last Updated: 2016-01-29
Results Overview
Drug effect will be assessed by ascertaining changes in brain activity between placebo and oxytocin sessions. Imaging data will be analyzed from all subjects in a final analysis. Individual subject analyses will be done on a bimonthly basis. Results represent neural responses to the anticipation of an uncertain reward within the Nucleus Accumbens (Bilateral). These are given as beta values (i.e. parameter estimates).
COMPLETED
PHASE2
20 participants
Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).
2016-01-29
Participant Flow
Participant milestones
| Measure |
Placebo Then Oxytocin
These participants were first studied using fMRI following self-administration of placebo (followed by another scanning session with oxytocin).
Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.
|
Oxytocin Then Placebo
These participants were first studied using fMRI following self-administration of oxytocin (followed by another scanning session with placebo).
Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo Then Oxytocin
These participants were first studied using fMRI following self-administration of placebo (followed by another scanning session with oxytocin).
Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.
|
Oxytocin Then Placebo
These participants were first studied using fMRI following self-administration of oxytocin (followed by another scanning session with placebo).
Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Deciphering the Role of Oxytocin in Motivation: an fMRI Study
Baseline characteristics by cohort
| Measure |
Participants
n=20 Participants
Each participant will complete baseline assessments prior to being studied using fMRI
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
22 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).Population: Only 8 participants' BOLD data were included in the final group analysis in the Placebo then Oxytocin arm -- 1 participant was excluded from the study prior to scanning, 1 participant was scanned but due to technical issues the BOLD data was not used.
Drug effect will be assessed by ascertaining changes in brain activity between placebo and oxytocin sessions. Imaging data will be analyzed from all subjects in a final analysis. Individual subject analyses will be done on a bimonthly basis. Results represent neural responses to the anticipation of an uncertain reward within the Nucleus Accumbens (Bilateral). These are given as beta values (i.e. parameter estimates).
Outcome measures
| Measure |
Placebo Then Oxytocin
n=8 Participants
Each participant will be studied using fMRI following self-administration of placebo.
Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.
|
Oxytocin Then Placebo
n=10 Participants
Each participant will be studied using fMRI following self-administration of oxytocin.
Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.
|
|---|---|---|
|
Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.
Placebo
|
0.7944 BOLD signal change (beta values)
Standard Error 0.3252
|
0.5790 BOLD signal change (beta values)
Standard Error 0.2515
|
|
Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.
Oxytocin
|
0.6119 BOLD signal change (beta values)
Standard Error 0.2040
|
0.6688 BOLD signal change (beta values)
Standard Error 0.3642
|
Adverse Events
Placebo Then Oxytocin
Oxytocin Then Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place