HealthyNCT02689596
Oxytocin and Resting State fMRI
A study testing Oxytocin in people with Healthy, run by University Hospital Heidelberg.
Trial summary
The goal of the study is to investigate the effects of intranasal oxytocin (OT) or placebo to resting state brain activity in healthy males. Read more about this study
- Who is it for?
- Ages 18 to 50 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
- Not given
- Where
- No sites listed yet
- Study dates
- Oct 2014to Oct 2015
- Phase
- Interventional
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Health
Who cannot join
- Chronic physical or mental illness, regular smoking or alcohol consumption and medication intake
About this study
Official title: Intranasal Oxytocin and Resting State fMRI in Healthy Volunteers
The goal of the study is to investigate the effects of intranasal oxytocin (OT) or placebo to resting state brain activity in healthy males.
Read the detailed description
Although several fMRI studies investigated the neural correlates of OT administration, only few have focused on the underlying modulatory effects of OT on baseline brain function. While functional MRI examines the neural activity during a certain task, it might be especially interesting to assess the main effect of OT on the basic activity of the human brain in rest. This resting state activity becomes typically evident in the default mode network (DMN), compromising midline structures such as medial frontal cortex, cingulate and precuneus, as well as specific resting state networks .
In fact, a recent study succeeded in demonstrating a modulatory influence of OT. Recent studies were able to show an increased functional connectivity at rest of amygdala to the medial prefrontal cortex (PFC) in a small sample of 15 subjects.
However, distinct subregions of the amygdala seem to be involved in different OT effects. To goal of the present study is to decipher the modulatory effects of OT to subregions of the amygdala in a larger sample using improved anatomical mapping of the seed regions and relate these alterations to individual traits of healthy volunteers. We expected to add evidence to the increase of amygdala - PFC connectivity under OT as well as detailed anatomical mapping of this networks.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| OT | Active comparator | Oxytocin Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting state brain activity using fMRI
Measured: 30min
Secondary outcomes (1)
Subject personality using questionnaires
Measured: 30min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startOct 2014
- Primary completionOct 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
- Phase N/A
- Primary purpose
- Basic science
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monika Eckstein, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689596
- Sponsor's protocol ID
- OT-REST14
- Status last verified
- Feb 2016
- First submitted
- 16 Feb 2016
- Last updated
- 24 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Oxytocin and Resting State fMRI in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02689596
- Acronym / sponsor ID
- OT-REST14
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- First posted
- 24 Feb 2016 (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 goal of the study is to investigate the effects of intranasal oxytocin (OT) or placebo to resting state brain activity in healthy males.
Detailed description
Although several fMRI studies investigated the neural correlates of OT administration, only few have focused on the underlying modulatory effects of OT on baseline brain function. While functional MRI examines the neural activity during a certain task, it might be especially interesting to assess the main effect of OT on the basic activity of the human brain in rest. This resting state activity becomes typically evident in the default mode network (DMN), compromising midline structures such as medial frontal cortex, cingulate and precuneus, as well as specific resting state networks .
In fact, a recent study succeeded in demonstrating a modulatory influence of OT. Recent studies were able to show an increased functional connectivity at rest of amygdala to the medial prefrontal cortex (PFC) in a small sample of 15 subjects.
However, distinct subregions of the amygdala seem to be involved in different OT effects. To goal of the present study is to decipher the modulatory effects of OT to subregions of the amygdala in a larger sample using improved anatomical mapping of the seed regions and relate these alterations to individual traits of healthy volunteers. We expected to add evidence to the increase of amygdala - PFC connectivity under OT as well as detailed anatomical mapping of this networks.
Study design
- Primary purpose
- Basic science
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OT | Active comparator | Drug: OxytocinOxytocin |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Health
Key exclusion criteria (1 listed)
- Chronic physical or mental illness, regular smoking or alcohol consumption and medication intake
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 | OT |
| Placebo | Other | Placebo |
Primary outcome
Resting state brain activity using fMRI
Time frame: 30min
1 secondary outcome
Subject personality using questionnaires
Time frame: 30min
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 24 Feb 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Healthy, run by University Hospital Heidelberg.
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 1 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 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Resting state brain activity using fMRI (time frame: 30min). 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 24 Feb 2016.