Mental Health Wellness 1NCT03085628
Sex- and Context-dependent Effects of Oxytocin on Social Reward Processing
A study testing Oxytocin in people with Mental Health Wellness 1 and Social Behavior, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
The aim of the present study is to examine whether the neuropeptide oxytocin (OXT) influences social reward processing and whether the effects are context- and sex-dependent. Read more about this study
- Who is it for?
- Ages 17 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, Social Behavior, Emotion
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy subjects without past or current psychiatric or neurological disorder, right-handed, had normal or corrected-to normal vision.
Who cannot join
- self-reported medication use, substance abuse, and presence of medical or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Keith Kendrick, Dr contact
Benjamin Becker, Dr contact
China1 site, 1 recruiting
- Recruiting
school of life science and technology, University of Electronic Science and Technology of China
Chengdu, Sichuan, 611731
Qin Li, Master, helenlee@uestc.edu.cn
About this study
The aim of the present study is to examine whether the neuropeptide oxytocin (OXT) influences social reward processing and whether the effects are context- and sex-dependent.
Read the 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).
- Conditions
- Mental Health Wellness 1, Social Behavior, Emotion
- Being tested
- Oxytocin, Placebo
- Keywords
- social sharing, social reward, functional magnetic resonance imaging, reward circuit
- Medical subject headings
- Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
40IU
PlaceboDrug
40IU
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Oxytoxin nasal spray Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Placebo nasal spray Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI: neural activity during social reward processing
Main effects of treatment will be analyzed on fMRI activity during a social reward processing paradigm.
Measured: 45-115 minutes after administration
Modulatory effects of sex on fMRI based neural indices during social reward processing
Interaction between treatment effects and sex will be analyzed on fMRI indices acquired during reward processing
Measured: 45-115 minutes after administration
fMRI: functional connectivity during social reward processing
Main effects of treatment will be analyzed on fMRI connectivity during a social reward processing paradigm.
Measured: 45-115 minutes after administration
Secondary outcomes (5)
Behavior: arousal ratings during social reward processing
Main effects of treatment will be analyzed on behavioral ratings of arousal acquired during the social reward processing paradigm.
Measured: 45-115 minutes after administration
Behavior: valence rating during social reward processing
Main effects of treatment will be analyzed on behavioral ratings of valence acquired during the social reward processing paradigm.
Measured: 45-115 minutes after administration
Modulatory effects of sex on arousal ratings during social reward processing
Interactions between treatment and sex will be analyzed on behavioral arousal ratings acquired during the social reward processing paradigm.
Measured: 45-115 minutes after administration
Modulatory effects of sex on valence ratings during social reward processing
Interactions between treatment and sex will be analyzed on behavioral valence ratings acquired during the social reward processing paradigm.
Measured: 45-115 minutes after administration
Pre-treatment modulators: attachment style (AAS)
Associations between neural and behavioral effects of treatment with pre-treatment attachment style as assessed by the Adult Attachment Scale (AAS)
Measured: 45-115 minutes after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study startJul 2016
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085628
- Sponsor's protocol ID
- UESTC-neuSCAN-08
- Status last verified
- Feb 2018
- First submitted
- 2 Mar 2017
- Last updated
- 7 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ma X, Zhao W, Luo R, Zhou F, Geng Y, Xu L, Gao Z, Zheng X, Becker B, Kendrick KM. Sex- and context-dependent effects of oxytocin on social sharing. Neuroimage. 2018 Dec;183:62-72. doi: 10.1016/j.neuroimage.2018.08.004. Epub 2018 Aug 4.
PubMed 30086408
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex- and Context-dependent Effects of Oxytocin on Social Reward Processing
- ClinicalTrials.gov ID
- NCT03085628
- Acronym / sponsor ID
- UESTC-neuSCAN-08
- Conditions
- Mental Health Wellness 1, Social Behavior, Emotion
- Keywords
- social sharing, social reward, functional magnetic resonance imaging, reward circuit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to examine whether the neuropeptide oxytocin (OXT) influences social reward processing and whether the effects are context- and sex-dependent.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: OxytocinOxytoxin nasal spray |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo nasal spray |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy subjects without past or current psychiatric or neurological disorder, right-handed, had normal or corrected-to normal vision.
Key exclusion criteria (1 listed)
- self-reported medication use, substance abuse, and presence of medical or psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin40IU | Drug | Oxytocin |
| Placebo40IU | Drug | Placebo |
Primary outcome
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.
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
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.
5 secondary outcomes
Behavior: arousal ratings during social reward processing
Time frame: 45-115 minutes after administration
Behavior: valence rating during social reward processing
Time frame: 45-115 minutes after administration
Modulatory effects of sex on arousal ratings during social reward processing
Time frame: 45-115 minutes after administration
Modulatory effects of sex on valence ratings during social reward processing
Time frame: 45-115 minutes after administration
Pre-treatment modulators: attachment style (AAS)
Time frame: 45-115 minutes after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Derived from this study: PubMed 30086408Ma X, Zhao W, Luo R, Zhou F, Geng Y, Xu L, Gao Z, Zheng X, Becker B, Kendrick KM. Sex- and context-dependent effects of oxytocin on social sharing. Neuroimage. 2018 Dec;183:62-72. doi: 10.1016/j.neuroimage.2018.08.004. Epub 2018 Aug 4.
- Individual participant dataSharing planned: Undecided
Related trials for Mental Health Wellness 1
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
RecruitingObservational study
Friends/Family of Individuals at Risk of Suicide Training Program
Caregiver, Caregiver Mental Health
Recruiting
GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Wellness in Adults
Sleep Disturbance, Stress
Not yet recruitingPhase 1
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
Schizophrenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Kendrick, Dr contact
Benjamin Becker, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Mental Health Wellness 1 and Social Behavior, run by University of Electronic Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keith Kendrick, Dr (kkendrick@uestc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI: neural activity during social reward processing (time frame: 45-115 minutes after administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03085628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.