The Impact of Oxytocin on Social CognitionPhase 2NCT02350946
Effects of Oxytocin on Emotion Recognition and Response Inhibition
A Phase 2 study testing Oxytocin in people with The Impact of Oxytocin on Social Cognition, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The purpose of this study is to shed light on the basic neurobiological mechanisms which underlie social information processing in healthy men. More specifically, we intend to examine whether a person's social competence level is related to the patterns of neural activity and his visual search strategies during… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- The Impact of Oxytocin on Social Cognition
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Jan 2017
- Phase
- Phase 2
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- MRI- eligibility
- Subject's ability to fully grasp the type, scope and individual consequences of the study
- Willingness to participate in and comply with the study procedures as indicated by signing the dated informed consent form
Who cannot join
- Left-handedness
- Smoking
- Regular intake of medication
- Hypersensitivity towards oxytocin or a chemically similar substance
- Current or previous neurological or psychiatric disorder
- Nose surgery or chronic sinus infection
- Any somatic disorder that may interfere with the experimental procedures, affect the outcome measures or pose a risk for the participant during performance of the experiment
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital RWTH Aachen
Aachen
Lisa Deuse, 02418085692, ldeuse@ukaachen.de
Gerhard Gründer
About this study
The purpose of this study is to shed light on the basic neurobiological mechanisms which underlie social information processing in healthy men. More specifically, we intend to examine whether a person's social competence level is related to the patterns of neural activity and his visual search strategies during evaluation of social scenes. Furthermore, it will be assessed whether an oxytocin-driven increase in activity in brain areas relevant to the task will facilitate social information processing and thus enhance task performance. Additionally it will be examined whether oxytocin can facilitate response inhibition in an emotional context.
- Being tested
- Oxytocin, Placebo
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 |
|---|---|---|
| Cross over Oxytocin and Placebo | Experimental | fMRI measurement and blood examinations following 26 IU Oxytocin (Syntocinon) on day 1 and following placebo on day 14 Receives: Drug: Oxytocin; Drug: Placebo |
| Cross over Placebo and Oxytocin | Experimental | fMRI measurement and blood examinations following placebo on day 1 and following 26 IU Oxytocin (Syntocinon) on day 14 Receives: Drug: Oxytocin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD response during emotion recognition in contrast with a corresponding control condition.
In the Social Detection Task, subjects' brain activity when viewing social scenes will be compared to corresponding control scenes in which no people are shown.
In the GoNoGo Task several emotional conditions will be compared to a neutral control condition.
Measured: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
BOLD response during response inhibition (Emotional Go/ Nogo) in contrast with a corresponding control condition.
Brain activation during NoGo trials will be compared to brain activation during Go trials from the same emotional condition.
Measured: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Secondary outcomes (7)
Serum levels of Oxytocin
Measured: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Serum levels of Prolaktin
Measured: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Serum levels of Cortisol
Measured: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Total length of fixations on areas of interest (AOIs) assessed via eye-tracking
In the SoDeTa stimulus set, faces, arms and hands were defined as 1st order AOIs and remaining parts of the body as 2nd order AOIs.
In the GoNoGo task, for each stimulus, the eye region of the face was chosen as AOI.
Measured: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Number of fixations on areas of interest (AOIs) assessed via eye-tracking
In the SoDeTa stimulus set, faces, arms and hands were defined as 1st order AOIs and remaining parts of the body as 2nd order AOIs.
In the GoNoGo task, for each stimulus, the eye region of the face was chosen as AOI.
Measured: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Percentage of correct responses in an emotion recognition paradigm (Social Detection Task) and a response inhibition task (Emotional Go/Nogo).
Measured: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Response time in an emotion recognition paradigm (Social Detection Task) and a response inhibition task (Emotional Go/Nogo).
Measured: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Impact of Oxytocin on Social CognitionStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350946
- Sponsor's protocol ID
- EK163/13
- Status last verified
- Jan 2015
- First submitted
- 20 Jan 2015
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oxytocin on Emotion Recognition and Response Inhibition
- ClinicalTrials.gov ID
- NCT02350946
- Acronym / sponsor ID
- EK163/13
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 30 Jan 2015 (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 study is to shed light on the basic neurobiological mechanisms which underlie social information processing in healthy men. More specifically, we intend to examine whether a person's social competence level is related to the patterns of neural activity and his visual search strategies during evaluation of social scenes. Furthermore, it will be assessed whether an oxytocin-driven increase in activity in brain areas relevant to the task will facilitate social information processing and thus enhance task performance. Additionally it will be examined whether oxytocin can facilitate response inhibition in an emotional context.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross over Oxytocin and Placebo | Experimental | Drug: Oxytocin, Drug: PlacebofMRI measurement and blood examinations following 26 IU Oxytocin (Syntocinon) on day 1 and following placebo on day 14 |
| Cross over Placebo and Oxytocin | Experimental | Drug: Oxytocin, Drug: PlacebofMRI measurement and blood examinations following placebo on day 1 and following 26 IU Oxytocin (Syntocinon) on day 14 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- MRI- eligibility
- Subject's ability to fully grasp the type, scope and individual consequences of the study
- Willingness to participate in and comply with the study procedures as indicated by signing the dated informed consent form
Key exclusion criteria (7 listed)
- Left-handedness
- Smoking
- Regular intake of medication
- Hypersensitivity towards oxytocin or a chemically similar substance
- Current or previous neurological or psychiatric 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 |
|---|---|---|
| Oxytocin | Drug | Cross over Oxytocin and Placebo, Cross over Placebo and Oxytocin |
| Placebo | Drug | Cross over Oxytocin and Placebo, Cross over Placebo and Oxytocin |
Primary outcome
BOLD response during emotion recognition in contrast with a corresponding control condition.
Time frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
In the Social Detection Task, subjects' brain activity when viewing social scenes will be compared to corresponding control scenes in which no people are shown. In the GoNoGo Task several emotional conditions will be compared to a neutral control condition.
BOLD response during response inhibition (Emotional Go/ Nogo) in contrast with a corresponding control condition.
Time frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Brain activation during NoGo trials will be compared to brain activation during Go trials from the same emotional condition.
7 secondary outcomes
Serum levels of Oxytocin
Time frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Serum levels of Prolaktin
Time frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Serum levels of Cortisol
Time frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Total length of fixations on areas of interest (AOIs) assessed via eye-tracking
Time frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Number of fixations on areas of interest (AOIs) assessed via eye-tracking
Time frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Percentage of correct responses in an emotion recognition paradigm (Social Detection Task) and a response inhibition task (Emotional Go/Nogo).
Time frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Response time in an emotion recognition paradigm (Social Detection Task) and a response inhibition task (Emotional Go/Nogo).
Time frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin in people with The Impact of Oxytocin on Social Cognition, run by RWTH Aachen University at 1 site in Germany.
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 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: status not confirmed, as of the sponsor's last update on 30 Jan 2015. 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 Germany. 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. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lisa Deuse (02418085692, ldeuse@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD response during emotion recognition in contrast with a corresponding control condition. (time frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])). The study lists 2 primary outcomes in all. 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 30 Jan 2015.