Healthy Male VolunteersPhase 1NCT01606462
Oxytocin and Social Cognition
A Phase 1 study testing Oxytocin in people with Healthy Male Volunteers, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether oxytocin influences memory of social stimuli and reaction to social stimuli. Furthermore the investigators explore the effect of oxytocin receptor (OXTR) polymorphism in terms of behavioral and neural responses to social stimuli. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Jun 2013
- Phase
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers
Who cannot join
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Tobacco smokers
- MRI contraindication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Placebo-controlled, Randomized Study: Oxytocin and OXTR-genotypes Influence Behavioral and Neural Social Reactions
The purpose of this study is to determine whether oxytocin influences memory of social stimuli and reaction to social stimuli. Furthermore the investigators explore the effect of oxytocin receptor (OXTR) polymorphism in terms of behavioral and neural responses to social stimuli.
Read the detailed description
The prevailing view of OXT as a key facilitator of prosocial behaviors has been highly influenced by a plethora of studies in healthy volunteers, which demonstrated increased interpersonal trust, generosity, social learning/empathy and positively biased social stimulus processing as a result of OXT treatment. However, this interpretation is challenged by observations that OXT also promotes envy and schadenfreude (gloating), ethno-centrism (including prejudice, xenophobia, and racial bias), and defensive aggression towards outsiders.We investigate the neural correlates of emotion perception and subsequent memory effects of aversive and neutral stimuli. Tthe oxytocin effect on personal space is questioned. Additionally the effect of OXTR polymorphism regarding behavioral and neural response is explored.
- Conditions
- Healthy Male Volunteers
- Being tested
- Oxytocin
- Keywords
- oxytocin, social cognition, fMRI, oxytocin receptor gene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Oxytocin: Syntocinon-Spray, Novartis
intranasal administration, 24 IU oxytocin; ; 3 puffs per nostril, each with 4 IU OXT
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | one application of 24 IU oxytocin per volunteer Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | sodium chloride solution, intranasal application, 3 puffs per nostril one application per volunteer Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
neural correlates of emotion perception and subsequent memory effects of aversive and neutral stimuli
MRI data are analyzed using SPM8 (Wellcome Trust Centre for Neuroimaging, London, UK). In the first level analysis the following conditions are modeled: 'neutral: subsequently remembered', 'neutral: subsequently forgotten', 'aversive: subsequently remembered', and 'aversive: subsequently forgotten'.
Measured: two years
Secondary outcomes (2)
the effect of oxytocin receptor (OXTR) polymorphism in terms of behavioral and neural responses to social stimuli
behavioral social testing, fMRI analysis using SPM8, OXTR genotyping
Measured: two years
The oxytocin effect on social behavior e.g. personal space is questioned
behavioral testing e.g. personal space
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rene Hurlemann, University Hospital, Bonn
- Investigators
- Rene Hurlemann, MSc MD PhD, Principal investigator, Department of Psychiatry, University of Bonn, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606462
- Sponsor's protocol ID
- OXT-071/10
- Status last verified
- Dec 2014
- First submitted
- 23 May 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled, Randomized Study: Oxytocin and OXTR-genotypes Influence Behavioral and Neural Social Reactions
- ClinicalTrials.gov ID
- NCT01606462
- Acronym / sponsor ID
- OXT-071/10
- Conditions
- Healthy Male Volunteers
- Keywords
- oxytocin, social cognition, fMRI, oxytocin receptor gene
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 May 2012 (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 determine whether oxytocin influences memory of social stimuli and reaction to social stimuli. Furthermore the investigators explore the effect of oxytocin receptor (OXTR) polymorphism in terms of behavioral and neural responses to social stimuli.
Detailed description
The prevailing view of OXT as a key facilitator of prosocial behaviors has been highly influenced by a plethora of studies in healthy volunteers, which demonstrated increased interpersonal trust, generosity, social learning/empathy and positively biased social stimulus processing as a result of OXT treatment. However, this interpretation is challenged by observations that OXT also promotes envy and schadenfreude (gloating), ethno-centrism (including prejudice, xenophobia, and racial bias), and defensive aggression towards outsiders.We investigate the neural correlates of emotion perception and subsequent memory effects of aversive and neutral stimuli. Tthe oxytocin effect on personal space is questioned. Additionally the effect of OXTR polymorphism regarding behavioral and neural response is explored.
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: Oxytocinone application of 24 IU oxytocin per volunteer |
| Placebo | Placebo comparator | Drug: Oxytocinsodium chloride solution, intranasal application, 3 puffs per nostril one application per volunteer |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male volunteers
Key exclusion criteria (5 listed)
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Tobacco smokers
- MRI contraindication
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: Syntocinon-Spray, Novartisintranasal administration, 24 IU oxytocin; ; 3 puffs per nostril, each with 4 IU OXT | Drug | Oxytocin, Placebo |
Primary outcome
neural correlates of emotion perception and subsequent memory effects of aversive and neutral stimuli
Time frame: two years
MRI data are analyzed using SPM8 (Wellcome Trust Centre for Neuroimaging, London, UK). In the first level analysis the following conditions are modeled: 'neutral: subsequently remembered', 'neutral: subsequently forgotten', 'aversive: subsequently remembered', and 'aversive: subsequently forgotten'.
2 secondary outcomes
the effect of oxytocin receptor (OXTR) polymorphism in terms of behavioral and neural responses to social stimuli
Time frame: two years
The oxytocin effect on social behavior e.g. personal space is questioned
Time frame: two years
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 3 Dec 2014.
- Click here for more information about the NEMO research groupLink provided by the sponsor.
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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.
Rene Hurlemann, MSc MD PhD principal investigator
Department of Psychiatry, University of Bonn, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxytocin in people with Healthy Male Volunteers, run by University Hospital, Bonn 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 1 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 3 Dec 2014. 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. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 correlates of emotion perception and subsequent memory effects of aversive and neutral stimuli (time frame: two years). 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 3 Dec 2014.