- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03085628
Sex- and Context-dependent Effects of Oxytocin on Social Reward Processing
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In a double-blind, randomized, placebo-controlled, between-subject design healthy volunteers will receive either oxytocin or placebo nasal spray (40IU in 10 puffs).
Subjects will come to the experiment in pairs (two friends of the same sex). 45 min after drug administration, the two subjects will simultaneously undergo a social reward task - during the task, functional magnetic resonance imaging (fMRI) data will be acquired from one of them. During the social reward task subjects will be asked to rate the valence and arousal of emotional pictures in three different conditions: alone, share with a stranger and share with their friend.
Before treatment, subjects will complete a range of validated questionnaires to control for potential confounders, such as level of depression (assessed using the BDI) and to explore associations between relevant personality factors and treatment effects, such as adult attachment style (assessed using the AAS).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Keith Kendrick, Dr
- Email: kkendrick@uestc.edu.cn
Study Contact Backup
- Name: Benjamin Becker, Dr
- Email: ben_becker@gmx.de
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 611731
- Recruiting
- School of Life Science and Technology, University of Electronic Science and Technology of China
-
Contact:
- Qin Li, Master
- Email: helenlee@uestc.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy subjects without past or current psychiatric or neurological disorder, right-handed, had normal or corrected-to normal vision.
Exclusion Criteria:
- self-reported medication use, substance abuse, and presence of medical or psychiatric disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo nasal spray
|
40IU
|
Experimental: Oxytocin
Oxytoxin nasal spray
|
40IU
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fMRI: neural activity during social reward processing
Time Frame: 45-115 minutes after administration
|
Main effects of treatment will be analyzed on fMRI activity during a social reward processing paradigm.
|
45-115 minutes after administration
|
Modulatory effects of sex on fMRI based neural indices during social reward processing
Time Frame: 45-115 minutes after administration
|
Interaction between treatment effects and sex will be analyzed on fMRI indices acquired during reward processing
|
45-115 minutes after administration
|
fMRI: functional connectivity during social reward processing
Time Frame: 45-115 minutes after administration
|
Main effects of treatment will be analyzed on fMRI connectivity during a social reward processing paradigm.
|
45-115 minutes after administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavior: arousal ratings during social reward processing
Time Frame: 45-115 minutes after administration
|
Main effects of treatment will be analyzed on behavioral ratings of arousal acquired during the social reward processing paradigm.
|
45-115 minutes after administration
|
Behavior: valence rating during social reward processing
Time Frame: 45-115 minutes after administration
|
Main effects of treatment will be analyzed on behavioral ratings of valence acquired during the social reward processing paradigm.
|
45-115 minutes after administration
|
Modulatory effects of sex on arousal ratings during social reward processing
Time Frame: 45-115 minutes after administration
|
Interactions between treatment and sex will be analyzed on behavioral arousal ratings acquired during the social reward processing paradigm.
|
45-115 minutes after administration
|
Modulatory effects of sex on valence ratings during social reward processing
Time Frame: 45-115 minutes after administration
|
Interactions between treatment and sex will be analyzed on behavioral valence ratings acquired during the social reward processing paradigm.
|
45-115 minutes after administration
|
Pre-treatment modulators: attachment style (AAS)
Time Frame: 45-115 minutes after administration
|
Associations between neural and behavioral effects of treatment with pre-treatment attachment style as assessed by the Adult Attachment Scale (AAS)
|
45-115 minutes after administration
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UESTC-neuSCAN-08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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