HealthyPhase 1NCT03846739
Dose-dependent Effects of Oxytocin on the Amygdala and Reward System
A Phase 1 study testing Oxytocin nasal spray in people with Healthy, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala and reward system responses vary as a function of treatment dose in women in comparison to men. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oxytocin nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteGermany
- Study dates
- 3 Apr 2017to 31 Dec 2018
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female volunteers
- Right-handed
- Non-smoker
Who cannot join
- Current psychiatric or physical illness
- Hormonal contraception
- Psychoactive medication
- MRI contraindication (e.g. metal in body, claustrophobia)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose-dependent Effects of Oxytocin on the Amygdala and Reward System Vary Between Women and Men
The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala and reward system responses vary as a function of treatment dose in women in comparison to men.
Read the detailed description
The objective of the present study is to determine whether intranasal oxytocin (IN-OXT) effects on blood oxygenation level-dependent functional magnetic resonance imaging (BOLD fMRI) in the amygdala and striatal regions (putamen, nucleus accumbens, caudate, pallidum) vary as a function of dose. In particular, the investigators plan to compare effects of three different IN-OXT doses (6, 12, and 24 international units, IU) on established neural and behavioural correlates of emotion processing in women. Results will be discussed in comparison to a previous study of OXT kinetics in men.
- Conditions
- Healthy
- Being tested
- Oxytocin nasal spray, Placebo
- Keywords
- amygdala, reward, oxytocin, dose, emotion processing, sex differences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal sprayDrug
Intranasal administration, 6, 12, or 24 international units (IU) oxytocin.
PlaceboDrug
The placebo nasal sprays contain identical ingredients except for the peptide itself.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin & Placebo, 6 IU | Active comparator | Intranasal administration, 6 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration. Receives: Drug: Oxytocin nasal spray; Drug: Placebo |
| Oxytocin & Placebo, 12 IU | Active comparator | Intranasal administration,12 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration. Receives: Drug: Oxytocin nasal spray; Drug: Placebo |
| Oxytocin & Placebo, 24 IU | Active comparator | Intranasal administration, 24 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration. Receives: Drug: Oxytocin nasal spray; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala
Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli. The investigators specifically plan to investigate amygdala responses to emotional faces, because previous studies found sex-specific effects of oxytocin on amygdala activation.
Measured: 45 min after nasal spray administration
Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in striatal regions (putamen, nucleus accumbens, caudate, pallidum)
Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli. The investigators specifically plan to investigate striatal responses to emotional faces to explore sex-specific effects of OXT on reward-related brain activation.
Measured: 45 min after nasal spray administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start3 Apr 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 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, MD, PhD, Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846739
- Sponsor's protocol ID
- PROXY2
- Status last verified
- Feb 2019
- First submitted
- 15 Feb 2019
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-dependent Effects of Oxytocin on the Amygdala and Reward System Vary Between Women and Men
- ClinicalTrials.gov ID
- NCT03846739
- Acronym / sponsor ID
- PROXY2
- Conditions
- Healthy
- Keywords
- amygdala, reward, oxytocin, dose, emotion processing, sex differences
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 20 Feb 2019 (actual)
- 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 effects of intranasal oxytocin on amygdala and reward system responses vary as a function of treatment dose in women in comparison to men.
Detailed description
The objective of the present study is to determine whether intranasal oxytocin (IN-OXT) effects on blood oxygenation level-dependent functional magnetic resonance imaging (BOLD fMRI) in the amygdala and striatal regions (putamen, nucleus accumbens, caudate, pallidum) vary as a function of dose. In particular, the investigators plan to compare effects of three different IN-OXT doses (6, 12, and 24 international units, IU) on established neural and behavioural correlates of emotion processing in women. Results will be discussed in comparison to a previous study of OXT kinetics in men.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxytocin & Placebo, 6 IU | Active comparator | Drug: Oxytocin nasal spray, Drug: PlaceboIntranasal administration, 6 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration. |
| Oxytocin & Placebo, 12 IU | Active comparator | Drug: Oxytocin nasal spray, Drug: PlaceboIntranasal administration,12 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration. |
| Oxytocin & Placebo, 24 IU | Active comparator | Drug: Oxytocin nasal spray, Drug: PlaceboIntranasal administration, 24 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy female volunteers
- Right-handed
- Non-smoker
Key exclusion criteria (5 listed)
- Current psychiatric or physical illness
- Hormonal contraception
- Psychoactive medication
- MRI contraindication (e.g. metal in body, claustrophobia)
- Pregnancy
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 nasal sprayIntranasal administration, 6, 12, or 24 international units (IU) oxytocin. | Drug | Oxytocin & Placebo, 12 IU, Oxytocin & Placebo, 24 IU, Oxytocin & Placebo, 6 IU |
| PlaceboThe placebo nasal sprays contain identical ingredients except for the peptide itself. | Drug | Oxytocin & Placebo, 12 IU, Oxytocin & Placebo, 24 IU, Oxytocin & Placebo, 6 IU |
Primary outcome
Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala
Time frame: 45 min after nasal spray administration
Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli. The investigators specifically plan to investigate amygdala responses to emotional faces, because previous studies found sex-specific effects of oxytocin on amygdala activation.
Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in striatal regions (putamen, nucleus accumbens, caudate, pallidum)
Time frame: 45 min after nasal spray administration
Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli. The investigators specifically plan to investigate striatal responses to emotional faces to explore sex-specific effects of OXT on reward-related brain activation.
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 28 Feb 2019.
- Neuromodulation of Emotion (NEMO) research groupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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, MD, PhD principal investigator
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 Phase 1 study testing Oxytocin nasal 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 3 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 28 Feb 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 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 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 substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala (time frame: 45 min after nasal spray administration). 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 28 Feb 2019.