HealthyEarly Phase 1NCT02740101
The Role of Oxytocin in Modulating the Effects of Social Feedback on Achieving Personal Goals
A Early Phase 1 study testing oxytocin treatment in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
To examine potential differential effects of receiving various social feedback on achieving personal goals,and whether oxytocin would modulate these effects. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- oxytocin treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Oct 2015
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without past or current psychiatric or neurological disorders.
Who cannot join
- Taking oral contraceptives;
- No history of head injury and medical or psychiatric illness.
Trial locations and contacts
1 site in 1 country.
China1 site
school of life science and technology, University of Electronic Science and Technology of China
Chengdu, Sichuan, 610054
About this study
To examine potential differential effects of receiving various social feedback on achieving personal goals,and whether oxytocin would modulate these effects.
Read the detailed description
In the present study, 62 healthy male participants participated in the double-blind, placebo-controlled experiment. Investigators aimed to test the idea that whether oxytocin would modulate subjective responses during receiving various social reward and social punishment about the future outcomes of pursuing personal goals.
- Conditions
- Healthy
- Being tested
- oxytocin treatment, placebo treatment
- Keywords
- oxytocin, social reward, social punishment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocin treatmentDrug
intranasal administration of oxytocin (40 IU)
placebo treatmentDrug
intranasal administration of placebo (40 IU)
| Study group | Role | What they receive |
|---|---|---|
| oxytocin nasal spray | Experimental | subjects administrating oxytocin were divided into experimental group Receives: Drug: oxytocin treatment |
| placebo nasal spray | Placebo comparator | subjects administrating placebo were divided into controlled group Receives: Drug: placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating of Encouragement after receiving specific social feedback
There're 96 different social feedback totally for four goals which were divided into four runs consisting of 24 different feedback separately for each goal video.Therefore,subjects were instructed to complete the encouragement rating after receiving each specific feedback. To measure the rating,the investigators used the 9-point likert scale in which one refers to the minimum encouragement while nine refers to maximum encouragement.
Measured: one hour
Secondary outcomes (1)
Rating of Likeability after receiving specific social feedback
There're 96 social feedback totally for four goals which were divided into four runs consisting of 24 feedback separately for each goal video.Therefore,subjects were instructed to complete the likeability rating after receiving each specific feedback. To measure the rating,the investigators used the 9-point likert scale in which one refers to the minimum likeability while nine refers to maximum likeability.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startNov 2014
- Primary completionAug 2015
- Study completionOct 2015
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 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, Dr., Principal investigator, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740101
- Sponsor's protocol ID
- UESTC-neuSCAN-14
- Status last verified
- Mar 2017
- First submitted
- 21 Mar 2016
- Last updated
- 6 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Oxytocin in Modulating the Effects of Social Feedback on Achieving Personal Goals
- ClinicalTrials.gov ID
- NCT02740101
- Acronym / sponsor ID
- UESTC-neuSCAN-14
- Conditions
- Healthy
- Keywords
- oxytocin, social reward, social punishment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Apr 2016 (estimated)
- 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.
To examine potential differential effects of receiving various social feedback on achieving personal goals,and whether oxytocin would modulate these effects.
Detailed description
In the present study, 62 healthy male participants participated in the double-blind, placebo-controlled experiment. Investigators aimed to test the idea that whether oxytocin would modulate subjective responses during receiving various social reward and social punishment about the future outcomes of pursuing personal goals.
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 nasal spray | Experimental | Drug: oxytocin treatmentsubjects administrating oxytocin were divided into experimental group |
| placebo nasal spray | Placebo comparator | Drug: placebo treatmentsubjects administrating placebo were divided into controlled group |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects without past or current psychiatric or neurological disorders.
Key exclusion criteria (2 listed)
- Taking oral contraceptives;
- No history of head injury and medical or psychiatric illness.
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 |
|---|---|---|
| oxytocin treatmentintranasal administration of oxytocin (40 IU) | Drug | oxytocin nasal spray |
| placebo treatmentintranasal administration of placebo (40 IU) | Drug | placebo nasal spray |
Primary outcome
Rating of Encouragement after receiving specific social feedback
Time frame: one hour
There're 96 different social feedback totally for four goals which were divided into four runs consisting of 24 different feedback separately for each goal video.Therefore,subjects were instructed to complete the encouragement rating after receiving each specific feedback. To measure the rating,the investigators used the 9-point likert scale in which one refers to the minimum encouragement while nine refers to maximum encouragement.
1 secondary outcome
Rating of Likeability after receiving specific social feedback
Time frame: one hour
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 Mar 2017.
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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, Dr. principal investigator
University of Electronic Science and Technology of China
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 treatment 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 1 inclusion and 2 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 Mar 2017. 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?
Rating of Encouragement after receiving specific social feedback (time frame: one hour). 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 Mar 2017.