HealthyEarly Phase 1NCT02501837
The Influence of Oxytocin on Pair-bonding and Emotion Regulation
A Early Phase 1 study testing Syntocinon-Spray in people with Healthy, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
The neuropeptide oxytocin (OXT) has been identified as a key modulator of human social behavior and it has been recently shown that OXT also contributes to pair-bonding in men. However, it is still elusive whether OXT has similar effects in women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Syntocinon-Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2014to Jun 2015
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female volunteers
- In a heterosexual relationship
Who cannot join
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
The neuropeptide oxytocin (OXT) has been identified as a key modulator of human social behavior and it has been recently shown that OXT also contributes to pair-bonding in men. However, it is still elusive whether OXT has similar effects in women. In the present study, the investigators examine the effect of intranasal OXT on behavioral ratings of and neural responses to the male partner in female participants. In a second experiment, the modulatory effect of OXT on emotion regulation is investigated.
- Conditions
- Healthy
- Being tested
- Syntocinon-Spray
- Keywords
- Healthy women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syntocinon-SprayDrug
Intranasal administration of 24 IU Oxytocin
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | 24 IU Oxytocin (Syntocinon spray), intranasal application 30 min prior to the experiment Receives: Drug: Syntocinon-Spray |
| Placebo | Placebo comparator | Intranasal application, containing all ingredients except for the peptide, 3 puffs per nostril Receives: Drug: Syntocinon-Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural response to photographs of the partner
Neural responses will be measured by using functional magnetic resonance imaging (fMRI). In the fMRI analysis the effect of oxytocin on the neural response to the photograph of the partner will be compared with placebo.
Measured: About one hour after the intranasal administration of oxytocin
Neural response during the regulation of food craving
Neural responses will be measured by using functional magnetic resonance imaging (fMRI). In the fMRI analysis the effect of oxytocin on the neural response to the regulation of food craving will be compared with placebo.
Measured: About one hour after the intranasal administration of oxytocin
Secondary outcomes (3)
Attractiveness ratings of all stimuli
The effect of oxytocin on attractiveness ratings of the partner will be compared with placebo. Ratings will be obtained by using a visual analog scale.
Measured: About one hour after the intranasal administration of oxytocin
Arousal ratings of all stimuli
The effect of oxytocin on arousal ratings of the partner will be compared with placebo. Ratings will be obtained by using a visual analog scale.
Measured: About one hour after the intranasal administration of oxytocin
Food craving ratings
The effect of oxytocin on food craving ratings will be compared with placebo. Ratings will be obtained by using a visual analog scale.
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 posted17 Jul 2015 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJun 2015
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
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501837
- Sponsor's protocol ID
- OXT_BOND
- Status last verified
- Jul 2015
- First submitted
- 15 Jul 2015
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Oxytocin on Pair-bonding and Emotion Regulation
- ClinicalTrials.gov ID
- NCT02501837
- Acronym / sponsor ID
- OXT_BOND
- Conditions
- Healthy
- Keywords
- Healthy women
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Jul 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 neuropeptide oxytocin (OXT) has been identified as a key modulator of human social behavior and it has been recently shown that OXT also contributes to pair-bonding in men. However, it is still elusive whether OXT has similar effects in women. In the present study, the investigators examine the effect of intranasal OXT on behavioral ratings of and neural responses to the male partner in female participants. In a second experiment, the modulatory effect of OXT on emotion regulation is investigated.
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: Syntocinon-Spray24 IU Oxytocin (Syntocinon spray), intranasal application 30 min prior to the experiment |
| Placebo | Placebo comparator | Drug: Syntocinon-SprayIntranasal application, containing all ingredients except for the peptide, 3 puffs per nostril |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy female volunteers
- In a heterosexual relationship
Key exclusion criteria (4 listed)
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Pregnant or lactating
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 |
|---|---|---|
| Syntocinon-SprayIntranasal administration of 24 IU Oxytocin | Drug | Oxytocin, Placebo |
Primary outcome
Neural response to photographs of the partner
Time frame: About one hour after the intranasal administration of oxytocin
Neural responses will be measured by using functional magnetic resonance imaging (fMRI). In the fMRI analysis the effect of oxytocin on the neural response to the photograph of the partner will be compared with placebo.
Neural response during the regulation of food craving
Time frame: About one hour after the intranasal administration of oxytocin
Neural responses will be measured by using functional magnetic resonance imaging (fMRI). In the fMRI analysis the effect of oxytocin on the neural response to the regulation of food craving will be compared with placebo.
3 secondary outcomes
Attractiveness ratings of all stimuli
Time frame: About one hour after the intranasal administration of oxytocin
Arousal ratings of all stimuli
Time frame: About one hour after the intranasal administration of oxytocin
Food craving ratings
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 17 Jul 2015.
- Homepage of the 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Syntocinon-Spray 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 17 Jul 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. 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?
Neural response to photographs of the partner (time frame: About one hour after the intranasal administration of oxytocin). 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 17 Jul 2015.