HealthyEarly Phase 1ODISNCT01701180
Neural Correlates of Empathogenic and Affiliative Actions of Oxytocin
A Early Phase 1 study testing Oxytocin in people with Healthy, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Mounting evidence indicates that the intranasal administration of the neuropeptide oxytocin has prosocial effects. However, the neural substrates of these effects are still unclear. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Aug 2013
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers
- In a heterosexual relationship
Who cannot join
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Tobacco smokers
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry, University of Bonn
Bonn, North Rhine-Westphalia, 53105
About this study
Official title: Neural Correlates of the Empathogenic and Affiliative Actions of Oxytocin
Mounting evidence indicates that the intranasal administration of the neuropeptide oxytocin has prosocial effects. However, the neural substrates of these effects are still unclear. The investigators hypothesized that a single dose administration of oxytocin should increase empathogenic and affiliative responses and that these effects are mediated by an increased insula activity.
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
24 IU; 3 puffs per nostril, each with 4 IU OXT
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | 24 IU Oxytocin, intranasal application 45 min prior to the experiment Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Intranasal application, sodium chloride solution, 3 puffs per nostril Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Empathy ratings and their neural correlates
All subjects are scanned while they view emotional and neutral faces and rate their empathy for these stimuli.
Measured: About one hour after the intranasal administration of oxytocin
Secondary outcomes (1)
Neural correlates of pair-bonding
All subjects are scanned while they view a picture of their mate and and an unknown female.
Measured: About one hour after the intranasal administration of oxytocin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionAug 2013
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 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
- René Hurlemann, MD PhD M.Sc., Principal investigator, Department of Psychiatry University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701180
- Sponsor's protocol ID
- OXT-151/12
- Other IDs
- OXT-151/12
- Acronym
- ODIS
- Status last verified
- Dec 2014
- First submitted
- 2 Oct 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
- Neural Correlates of the Empathogenic and Affiliative Actions of Oxytocin
- ClinicalTrials.gov ID
- NCT01701180
- Acronym / sponsor ID
- ODIS / OXT-151/12
- Conditions
- Healthy
- Keywords
- Male Volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Oct 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.
Mounting evidence indicates that the intranasal administration of the neuropeptide oxytocin has prosocial effects. However, the neural substrates of these effects are still unclear. The investigators hypothesized that a single dose administration of oxytocin should increase empathogenic and affiliative responses and that these effects are mediated by an increased insula activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: Oxytocin24 IU Oxytocin, intranasal application 45 min prior to the experiment |
| Placebo | Placebo comparator | Drug: PlaceboIntranasal application, sodium chloride solution, 3 puffs per nostril |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male volunteers
- In a heterosexual relationship
Key exclusion criteria (4 listed)
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Tobacco smokers
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, Novartis24 IU; 3 puffs per nostril, each with 4 IU OXT | Drug | Oxytocin |
| Placebo | Drug | Placebo |
Primary outcome
Empathy ratings and their neural correlates
Time frame: About one hour after the intranasal administration of oxytocin
All subjects are scanned while they view emotional and neutral faces and rate their empathy for these stimuli.
1 secondary outcome
Neural correlates of pair-bonding
Time frame: About one hour after the intranasal administration of oxytocin
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.
- 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.
René Hurlemann, MD PhD M.Sc. principal investigator
Department of Psychiatry University of Bonn
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 Healthy, 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 2 inclusion and 4 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?
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?
Empathy ratings and their neural correlates (time frame: About one hour after the intranasal administration of oxytocin). 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.