Facial ExpressionsEarly Phase 1NCT02183948
Effect of Oxytocin on Masked Facial Expressions: an fMRI Study
A Early Phase 1 study testing Oxytocin in people with Facial Expressions, run by University of Electronic Science and Technology of China.
Trial summary
The purpose is to test whether oxytocin has an effect on masked facial expressions Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Facial Expressions
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Dec 2014
- 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 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy subjects, no smoke or drink alcohol, coffee or other stimulants during the day before Experiment.
Who cannot join
- history of head injury; pregnancy; uterine cavity operations were took within one year; medical or psychiatric illness; rhinitis in case they may not fully absorb the spray.
About this study
The purpose is to test whether oxytocin has an effect on masked facial expressions
Read the detailed description
The neuropeptide oxytocin (OXT) has been shown to modulate several aspects of human social cognition. Although the exact mechanisms behind these effects remain unclear, recent research suggests that OXT modulates the perception of cues that are important for interpersonal processing, particularly emotional facial expressions. Using a backward masking procedure and functional magnetic resonance imaging, we investigated the modulatory effects of intranasal OXT on the processing of sub-liminally presented emotional faces. In a double-blind placebo-controlled between-subject pharmaco-fMRI experiment healthy volunteers received either 24IU of intranasal oxytocin or placebo 45mins before they were presented emotional (happy, angry, fearful, sad, disgusting) faces and mirror-reversed neutral faces masked by neutral faces of the same individual. To ensure attentional processing of the faces subjects were required to perform a simple gender decision task in the scanner and a recognition memory task afterwards. All subjects were additionally assessed for their state and trait anxiety and depression as well as empathy. For the analysis, we will use matlab, SPM and SPSS to conduct structural ROI analysis and two Sample t test.
- Conditions
- Facial Expressions
- Being tested
- Oxytocin, Placebo
- Keywords
- treatment, mask face exoressions, genier
- Medical subject headings
- Facial Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| oxytocin | Experimental | nasal spray Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | nasal spray Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with neuro activity to facial expressions
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial ExpressionsStudies 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
- 86 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183948
- Sponsor's protocol ID
- UESTC-SCAN-01
- Other IDs
- UESTC-SCAN-01
- Status last verified
- Mar 2017
- First submitted
- 30 Jun 2014
- Last updated
- 7 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oxytocin on Masked Facial Expressions: an fMRI Study
- ClinicalTrials.gov ID
- NCT02183948
- Acronym / sponsor ID
- UESTC-SCAN-01
- Conditions
- Facial Expressions
- Keywords
- treatment, mask face exoressions, genier
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Jul 2014 (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.
The purpose is to test whether oxytocin has an effect on masked facial expressions
Detailed description
The neuropeptide oxytocin (OXT) has been shown to modulate several aspects of human social cognition. Although the exact mechanisms behind these effects remain unclear, recent research suggests that OXT modulates the perception of cues that are important for interpersonal processing, particularly emotional facial expressions. Using a backward masking procedure and functional magnetic resonance imaging, we investigated the modulatory effects of intranasal OXT on the processing of sub-liminally presented emotional faces. In a double-blind placebo-controlled between-subject pharmaco-fMRI experiment healthy volunteers received either 24IU of intranasal oxytocin or placebo 45mins before they were presented emotional (happy, angry, fearful, sad, disgusting) faces and mirror-reversed neutral faces masked by neutral faces of the same individual. To ensure attentional processing of the faces subjects were required to perform a simple gender decision task in the scanner and a recognition memory task afterwards. All subjects were additionally assessed for their state and trait anxiety and depression as well as empathy. For the analysis, we will use matlab, SPM and SPSS to conduct structural ROI analysis and two Sample t test.
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: Oxytocinnasal spray |
| Placebo | Placebo comparator | Drug: Placebonasal spray |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects, no smoke or drink alcohol, coffee or other stimulants during the day before Experiment.
Key exclusion criteria (1 listed)
- history of head injury; pregnancy; uterine cavity operations were took within one year; medical or psychiatric illness; rhinitis in case they may not fully absorb the spray.
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 | Drug | oxytocin |
| Placebo | Drug | Placebo |
Primary outcome
Number of participants with neuro activity to facial expressions
Time frame: one week
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 7 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oxytocin in people with Facial Expressions, run by University of Electronic Science and Technology of 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: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of participants with neuro activity to facial expressions (time frame: one week). 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 7 Mar 2017.