Social CognitionEarly Phase 1NCT02228031
Oxytocin, Emotions and Mirror Neurons
A Early Phase 1 study testing Oxytocin in people with Social Cognition and Expressed Emotion, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this project is to investigate the possible effect of intranasally administered Oxytocin (OT) on specific mirror neuron areas in human brain. The mirror neuron system (MNS) is thought to be involved in action perception and understanding, and may also underlie more complex cognitive processes such as… 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
- Social Cognition, Expressed Emotion
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Aug 2016
- 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
- Right-hand dominant
- Sufficient spoken English so as to be able to complete testing validly and give informed consent
Who cannot join
- Currently taking any psychotropic or cognition enhancing medication
- History of schizophrenia or any other psychotic disorder, including Bipolar Disorder
- Family history of psychosis
- Neurological disease or clinically significant head injury
- Physical disability that substantially impairs motor function
- Current diagnosis of polydypsic-induced hyponatremia
- Substance dependence or abuse in the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Child Development Lab, University of Maryland
College Park, Maryland, 20742
About this study
Official title: The Influence of Oxytocin on the Mirror Neuron System: Developing Brain Imaging Paradigms for Future Therapeutic Interventions
The purpose of this project is to investigate the possible effect of intranasally administered Oxytocin (OT) on specific mirror neuron areas in human brain. The mirror neuron system (MNS) is thought to be involved in action perception and understanding, and may also underlie more complex cognitive processes such as imitation. We will use electroencephalographic (EEG) investigations to examine brain activity while participants complete two different tasks, consisting of the observation and imitation of emotional facial expressions (video presented) and the observation and execution of simple grasping actions (live presented), respectively. In addition, before the beginning of the EEG recording session, subjects will be randomly assigned to two different groups (Oxytocin or Placebo group) and will receive a dose of either intranasal Oxytocin or Placebo solution. Oxytocin is a polypeptide hormone that plays a critical role in social behavior. We will identify mu and beta rhythm from the ongoing EEG and examine suppression as a function of emotion and goal directed action perception and imitation/execution.
- Conditions
- Social Cognition, Expressed Emotion
- Being tested
- Oxytocin, Placebo
- Keywords
- Mirror neurons, Imitation, Oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon nasal spray
The experimental oxytocin group will receive 24 international units (IU) of oxytocin using an intranasal administration (self-administered nasal spray) one time before the experimental session
PlaceboOther
The placebo comparator group will receive sterile saline through intranasal administration, consisting of the same salt solution in which the hormone will be dissolved , but lacking the hormone itself.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | The experimental oxytocin group will receive 24 international units (IU) of oxytocin using an intranasal administration (self-administered nasal spray) one time before the experimental session. Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | The placebo comparator group will receive sterile saline through intranasal administration, consisting of the same salt solution in which the hormone will be dissolved , but lacking the hormone itself. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG mu rhythm suppression
The EEG mu rhythm suppression is an index of the human mirror neuron system (alpha and lower beta band activity (8-13 and ~20Hz) recorded over the sensorimotor cortex. EEG will be recorded during the performance of an emotion imitation task (Carr et al., 2003) in which participants will be asked to imitate and internally generate facial emotions seen on a computer screen, or to simply observe, as well as performing a simple grasping action task. Changes in the mu suppression while the performance of these tasks, before and after oxytocin/placebo administration, will be the primary outcome measure.
Measured: Before oxytocin/placebo administration and 45 minutes after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2016
- Study completionAug 2016
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 Social CognitionStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, College Park
- Responsible party
- Principal investigator, Robert Buchanan, University of Maryland, Baltimore
- Investigators
- Robert W Buchanan, MD, Principal investigator, University of Maryland, College ParkNathan Fox, PhD, Study director, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228031
- Sponsor's protocol ID
- HP-00059904
- Status last verified
- Aug 2019
- First submitted
- 15 Aug 2014
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Carr L, Iacoboni M, Dubeau MC, Mazziotta JC, Lenzi GL. Neural mechanisms of empathy in humans: a relay from neural systems for imitation to limbic areas. Proc Natl Acad Sci U S A. 2003 Apr 29;100(9):5497-502. doi: 10.1073/pnas.0935845100. Epub 2003 Apr 7.
PubMed 12682281
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Oxytocin on the Mirror Neuron System: Developing Brain Imaging Paradigms for Future Therapeutic Interventions
- ClinicalTrials.gov ID
- NCT02228031
- Acronym / sponsor ID
- HP-00059904
- Conditions
- Social Cognition, Expressed Emotion
- Keywords
- Mirror neurons, Imitation, Oxytocin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- University of Maryland, College Park
- Study start
- Oct 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 28 Aug 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 of this project is to investigate the possible effect of intranasally administered Oxytocin (OT) on specific mirror neuron areas in human brain. The mirror neuron system (MNS) is thought to be involved in action perception and understanding, and may also underlie more complex cognitive processes such as imitation. We will use electroencephalographic (EEG) investigations to examine brain activity while participants complete two different tasks, consisting of the observation and imitation of emotional facial expressions (video presented) and the observation and execution of simple grasping actions (live presented), respectively. In addition, before the beginning of the EEG recording session, subjects will be randomly assigned to two different groups (Oxytocin or Placebo group) and will receive a dose of either intranasal Oxytocin or Placebo solution. Oxytocin is a polypeptide hormone that plays a critical role in social behavior. We will identify mu and beta rhythm from the ongoing EEG and examine suppression as a function of emotion and goal directed action perception and imitation/execution.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: OxytocinThe experimental oxytocin group will receive 24 international units (IU) of oxytocin using an intranasal administration (self-administered nasal spray) one time before the experimental session. |
| Placebo | Placebo comparator | Other: PlaceboThe placebo comparator group will receive sterile saline through intranasal administration, consisting of the same salt solution in which the hormone will be dissolved , but lacking the hormone itself. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Right-hand dominant
- Sufficient spoken English so as to be able to complete testing validly and give informed consent
Key exclusion criteria (7 listed)
- Currently taking any psychotropic or cognition enhancing medication
- History of schizophrenia or any other psychotic disorder, including Bipolar Disorder
- Family history of psychosis
- Neurological disease or clinically significant head injury
- Physical disability that substantially impairs motor function
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: Syntocinon nasal sprayThe experimental oxytocin group will receive 24 international units (IU) of oxytocin using an intranasal administration (self-administered nasal spray) one time before the experimental session | Drug | Oxytocin |
| PlaceboThe placebo comparator group will receive sterile saline through intranasal administration, consisting of the same salt solution in which the hormone will be dissolved , but lacking the hormone itself. | Other | Placebo |
Primary outcome
EEG mu rhythm suppression
Time frame: Before oxytocin/placebo administration and 45 minutes after
The EEG mu rhythm suppression is an index of the human mirror neuron system (alpha and lower beta band activity (8-13 and ~20Hz) recorded over the sensorimotor cortex. EEG will be recorded during the performance of an emotion imitation task (Carr et al., 2003) in which participants will be asked to imitate and internally generate facial emotions seen on a computer screen, or to simply observe, as well as performing a simple grasping action task. Changes in the mu suppression while the performance of these tasks, before and after oxytocin/placebo administration, will be the primary outcome measure.
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 19 Aug 2019.
- Background: PubMed 12682281Carr L, Iacoboni M, Dubeau MC, Mazziotta JC, Lenzi GL. Neural mechanisms of empathy in humans: a relay from neural systems for imitation to limbic areas. Proc Natl Acad Sci U S A. 2003 Apr 29;100(9):5497-502. doi: 10.1073/pnas.0935845100. Epub 2003 Apr 7.
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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.
Robert W Buchanan, MD principal investigator
University of Maryland, College Park
Nathan Fox, PhD study director
University of Maryland, College Park
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 Social Cognition and Expressed Emotion, run by University of Maryland, Baltimore at 1 site in United States.
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 2 inclusion and 7 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 19 Aug 2019. 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 United States. 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?
EEG mu rhythm suppression (time frame: Before oxytocin/placebo administration and 45 minutes after). 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 NCT02228031, 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 19 Aug 2019.