HealthyEarly Phase 1NCT03084029
The Neural Basis of Oxytocin's Effects on Empathy
A Early Phase 1 study testing Oxytocin in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
The main focus of this study is to examine oxytocin effects on behavioral and neural indices of empathy processing. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Sep 2017
- Phase
- Early Phase 1
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without past or current psychiatric or neurological disorders
- no smoking at least 12 hours before experiment
- no alcohol, coffee or other stimulant drinking at least 12 hours before experiment
Who cannot join
- mental implants
- pregnancy
- uterine cavity operations
- use of medication
- acute physical disorder
Trial locations and contacts
1 site in 1 country.
China1 site
School of Life Science and Technology,University of Electronic Science and Technology
Chengdu, Sichuan
About this study
The main focus of this study is to examine oxytocin effects on behavioral and neural indices of empathy processing.
Read the detailed description
The neuropeptide oxytocin (OXT) has been demonstrated to modulate empathy in previous behavioural studies. The present study aims at replicating previous findings on OXT on empathy as well as to determine the neural basis of these effects.
In a between-subject, randomized double-blind design, subjects will be either administered intranasal OXT or placebo nasal spray (40 IU). 45 minutes after administration subjects will undergo (fMRI) tasks of empathic processing.
During the tasks subjects will be shown empathy inducing stimuli, and the behavioral and neural response in terms of cognitive, emotional and indirect emotional empathy will be assessed.
Before the administration of treatment, validated questionnaires assessing potential confounding variables, such as depression (Becks Depression Inventory (BDI)) or mood (Positive And Negative Affect Scale (PANAS)) will be administered to the subjects.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Oxytocin Treatment
40 international units
PlaceboDrug
Also called Placebo treatment
40 international units
| Study group | Role | What they receive |
|---|---|---|
| male participants - oxytocin nasal spray | Experimental | male participants - receiving a single dose of 40 IU intranasal oxytocin Receives: Drug: Oxytocin |
| female participants - oxytocin nasal spray | Experimental | female participants - receiving a single dose of 40 IU intranasal oxytocin Receives: Drug: Oxytocin |
| male participants - placebo nasal spray | Placebo comparator | male participants - receiving a single dose of 40 IU intranasal placebo Receives: Drug: Placebo |
| female participants - placebo nasal spray | Placebo comparator | female participants - receiving a single dose of 40 IU intranasal placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural processing of empathy as assessed using fMRI
Main effects of treatment and interaction between treatment effects and sex will be assessed on brain activity and connectivity in core regions of the empathy networks during processing of empathy inducing pictures
Measured: 45-115 minutes after single dose administration
Secondary outcomes (1)
Behavioral ratings of subjective experienced empathy processing
Main effects of treatment and interaction between treatment effects and sex will be assessed on subjective feelings of empathy (ratings on a Likert scale in response to empathy inducing pictures).
Measured: 45-115 minutes after single dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study startJan 2016
- Primary completionJun 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Kendrick, University of Electronic Science and Technology of China
- Investigators
- Keith Kendrick, PhD, Principal investigator, China,Sichuan, School of Life Science and Technology,University of Electronic Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084029
- Sponsor's protocol ID
- UESTC-neuSCAN-03
- Status last verified
- Feb 2018
- First submitted
- 15 Apr 2016
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neural Basis of Oxytocin's Effects on Empathy
- ClinicalTrials.gov ID
- NCT03084029
- Acronym / sponsor ID
- UESTC-neuSCAN-03
- Conditions
- Healthy
- Keywords
- oxytocin, fMRI, empathy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 20 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 main focus of this study is to examine oxytocin effects on behavioral and neural indices of empathy processing.
Detailed description
The neuropeptide oxytocin (OXT) has been demonstrated to modulate empathy in previous behavioural studies. The present study aims at replicating previous findings on OXT on empathy as well as to determine the neural basis of these effects.
In a between-subject, randomized double-blind design, subjects will be either administered intranasal OXT or placebo nasal spray (40 IU). 45 minutes after administration subjects will undergo (fMRI) tasks of empathic processing.
During the tasks subjects will be shown empathy inducing stimuli, and the behavioral and neural response in terms of cognitive, emotional and indirect emotional empathy will be assessed.
Before the administration of treatment, validated questionnaires assessing potential confounding variables, such as depression (Becks Depression Inventory (BDI)) or mood (Positive And Negative Affect Scale (PANAS)) will be administered to the subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| male participants - oxytocin nasal spray | Experimental | Drug: Oxytocinmale participants - receiving a single dose of 40 IU intranasal oxytocin |
| female participants - oxytocin nasal spray | Experimental | Drug: Oxytocinfemale participants - receiving a single dose of 40 IU intranasal oxytocin |
| male participants - placebo nasal spray | Placebo comparator | Drug: Placebomale participants - receiving a single dose of 40 IU intranasal placebo |
| female participants - placebo nasal spray | Placebo comparator | Drug: Placebofemale participants - receiving a single dose of 40 IU intranasal placebo |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects without past or current psychiatric or neurological disorders
- no smoking at least 12 hours before experiment
- no alcohol, coffee or other stimulant drinking at least 12 hours before experiment
Key exclusion criteria (5 listed)
- mental implants
- pregnancy
- uterine cavity operations
- use of medication
- acute physical disorder
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 |
|---|---|---|
| OxytocinAlso: Oxytocin Treatment40 international units | Drug | female participants - oxytocin nasal spray, male participants - oxytocin nasal spray |
| PlaceboAlso: Placebo treatment40 international units | Drug | female participants - placebo nasal spray, male participants - placebo nasal spray |
Primary outcome
Neural processing of empathy as assessed using fMRI
Time frame: 45-115 minutes after single dose administration
Main effects of treatment and interaction between treatment effects and sex will be assessed on brain activity and connectivity in core regions of the empathy networks during processing of empathy inducing pictures
1 secondary outcome
Behavioral ratings of subjective experienced empathy processing
Time frame: 45-115 minutes after single dose administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Individual participant dataSharing planned: No
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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, PhD principal investigator
China,Sichuan, School of Life Science and Technology,University of Electronic Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oxytocin in people with Healthy, 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 6 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural processing of empathy as assessed using fMRI (time frame: 45-115 minutes after single dose administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2018.