AgingNCT01823146
Oxytocin's Effect on Socioemotional Aging
A study testing Oxytocin spray in people with Aging, run by University of Florida at 1 site in United States.
Trial summary
This study will investigate the extent to which intranasal oxytocin affects changes in social decision making and evaluations of others. Oxytocin is a hormone that naturally occurs in the body and the brain and has been shown to be relevant for many behaviors, particularly in social situations. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Oxytocin spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18-30 years or 63-85 years
- English fluency
- Caucasian
- Right-handed
Who cannot join
- Pregnant or possibly pregnant
- Breastfeeding
- Claustrophobia
- Currently on vasoconstrictors, pseudoephedrine or antidiuretic medication
- Large pieces of metal in the body, particularly in the face or neck
- Piercings or metal implants that cannot be removed from the body
Show all 9Show fewer
- Surgery on the brain or any prior serious brain damage or disease
- Dementia or severe cognitive disorders
- History of hyponatremia, Syndrome of Inappropriate Antidiuretic Hormone, psychogenic polydipsia, or motion disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida
Gainesville, Florida, 32611-2250
About this study
Official title: Oxytocin and Aging: Neuro-Behavioral Effects on Social Cognition and Prosocial Behavior
This study will investigate the extent to which intranasal oxytocin affects changes in social decision making and evaluations of others. Oxytocin is a hormone that naturally occurs in the body and the brain and has been shown to be relevant for many behaviors, particularly in social situations. Research on the effects of oxytocin in aging is very scarce; therefore, the purpose of this research project is to determine the effects of oxytocin on socioemotional aging.
Read the detailed description
In order to demonstrate oxytocin as a causal mechanism in socioemotional aging, the investigators propose to temporarily elevate oxytocin levels and then measure activity in the brain while participants engage in socially relevant tasks. Participants in this study will be randomly assigned (much like flipping a coin) to receive either a single administration of oxytocin or a placebo (a substance that looks like the oxytocin but does not have any active drug). Neither participants nor the investigator will know to which condition each participant is assigned. Prior to being enrolled into the study a screening to determine eligibility will be conducted. Once the screening visit is completed and it has been determined that subjects can be randomized into the study, an appointment will be scheduled for the full study visit.
The purpose of the screening is to determine whether the individual is eligible for participation in the study and will consist of a series of questions about demographics and health history, two saliva samples, two short tasks, blood test, and brief meeting with a licensed clinician to ensure that it is safe for the individual to take part in the magnetic resonance imaging (MRI) and drug administration.
The study visit will comprise two collections of saliva for laboratory tests prior to and following the oxytocin administration in order to measure levels of the hormone in the body at baseline and after the spray. Saliva samples will also allow for an examination of how oxytocin-related genes may impact cognition and behavior during study tasks. Participants will work on various social tasks while in the MRI scanner, and response accuracy, response time, and brain activity will be recorded. After the scan, participants will complete a series of brief questionnaires on paper and on the computer.
- Conditions
- Aging
- Being tested
- Oxytocin spray, Placebo spray
- Keywords
- oxytocin, socioemotional functioning, trust, amygdala, aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin sprayDrug
single dose of 24 IU oxytocin, self-administered intranasally (IN)
Placebo sprayDrug
single dose of 24 IU placebo (same solution as oxytocin spray but without oxytocin), self-administered intranasally (IN)
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin spray | Experimental | single dose of 24 IU oxytocin, self-administered intranasally (IN) Receives: Drug: Oxytocin spray |
| Placebo spray | Placebo comparator | single dose of 24 IU placebo (same solution as oxytocin spray but without oxytocin), self-administered intranasally (IN) Receives: Drug: Placebo spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of Trust Behavior
Average amount of monetary units invested in the context of the Trust/Lottery Game.
The theoretical range was 0 to 72 monetary units across all 24 trials. Participants invested in 12 social (human person) and 12 non-social (computer) trials.The mean average amount of monetary units invested was calculated for social and non-social trials separately.
Measured: 45 minutes after drug/placebo administration
Secondary outcomes (2)
Meta-Mood
Mean self-reported level of meta-mood for the two subscales attention to feelings and clarity of feelings. Response scale ranged from 1 to 5, with higher scores indicating more attention to feelings and greater clarity of feelings, respectively. The mean score for the subscales were calculated.
Measured: 2.5 hours after drug/placebo administration
Functional Connectivity (Resting fMRI)
The functional connectivity (strength measure in units on a scale) between amygdala and medial prefrontal cortex was measured via a resting functional magnetic resonance imaging scan (participants looked at a fixation cross while images of their brain at rest were taken). Functional connectivity is the connectivity between brain regions (i.e., amygdala and medial prefrontal cortex) that share functional properties. It is defined as the temporal correlation between spatially remote neurophysiological events, expressed as deviation from statistical independence across these events in distributed neuronal groups and areas. A mean of this correlation (connectivity strength) was computed and transformed into z-scores (r to z transformation). The z-scores ranged from -2 to +2 with higher scores representing a greater resting-state functional connectivity.
Measured: 1.5 hours after oxytocin/placebo administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalie C Ebner, PhD, Principal investigator, University of Florida, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823146
- Sponsor's protocol ID
- 39-2013
- Other IDs
- UL1TR000064
- Status last verified
- Oct 2015
- First submitted
- 25 Mar 2013
- Last updated
- 25 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin and Aging: Neuro-Behavioral Effects on Social Cognition and Prosocial Behavior
- ClinicalTrials.gov ID
- NCT01823146
- Acronym / sponsor ID
- 39-2013
- Conditions
- Aging
- Keywords
- oxytocin, socioemotional functioning, trust, amygdala, aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Posted 17 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the extent to which intranasal oxytocin affects changes in social decision making and evaluations of others. Oxytocin is a hormone that naturally occurs in the body and the brain and has been shown to be relevant for many behaviors, particularly in social situations. Research on the effects of oxytocin in aging is very scarce; therefore, the purpose of this research project is to determine the effects of oxytocin on socioemotional aging.
Detailed description
In order to demonstrate oxytocin as a causal mechanism in socioemotional aging, the investigators propose to temporarily elevate oxytocin levels and then measure activity in the brain while participants engage in socially relevant tasks. Participants in this study will be randomly assigned (much like flipping a coin) to receive either a single administration of oxytocin or a placebo (a substance that looks like the oxytocin but does not have any active drug). Neither participants nor the investigator will know to which condition each participant is assigned. Prior to being enrolled into the study a screening to determine eligibility will be conducted. Once the screening visit is completed and it has been determined that subjects can be randomized into the study, an appointment will be scheduled for the full study visit.
The purpose of the screening is to determine whether the individual is eligible for participation in the study and will consist of a series of questions about demographics and health history, two saliva samples, two short tasks, blood test, and brief meeting with a licensed clinician to ensure that it is safe for the individual to take part in the magnetic resonance imaging (MRI) and drug administration.
The study visit will comprise two collections of saliva for laboratory tests prior to and following the oxytocin administration in order to measure levels of the hormone in the body at baseline and after the spray. Saliva samples will also allow for an examination of how oxytocin-related genes may impact cognition and behavior during study tasks. Participants will work on various social tasks while in the MRI scanner, and response accuracy, response time, and brain activity will be recorded. After the scan, participants will complete a series of brief questionnaires on paper and on the computer.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin spray | Experimental | Drug: Oxytocin spraysingle dose of 24 IU oxytocin, self-administered intranasally (IN) |
| Placebo spray | Placebo comparator | Drug: Placebo spraysingle dose of 24 IU placebo (same solution as oxytocin spray but without oxytocin), self-administered intranasally (IN) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between the ages of 18-30 years or 63-85 years
- English fluency
- Caucasian
- Right-handed
Key exclusion criteria (9 listed)
- Pregnant or possibly pregnant
- Breastfeeding
- Claustrophobia
- Currently on vasoconstrictors, pseudoephedrine or antidiuretic medication
- Large pieces of metal in the body, particularly in the face or neck
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 spraysingle dose of 24 IU oxytocin, self-administered intranasally (IN) | Drug | Oxytocin spray |
| Placebo spraysingle dose of 24 IU placebo (same solution as oxytocin spray but without oxytocin), self-administered intranasally (IN) | Drug | Placebo spray |
Primary outcome
Extent of Trust Behavior
Time frame: 45 minutes after drug/placebo administration
Average amount of monetary units invested in the context of the Trust/Lottery Game. The theoretical range was 0 to 72 monetary units across all 24 trials. Participants invested in 12 social (human person) and 12 non-social (computer) trials.The mean average amount of monetary units invested was calculated for social and non-social trials separately.
2 secondary outcomes
Meta-Mood
Time frame: 2.5 hours after drug/placebo administration
Functional Connectivity (Resting fMRI)
Time frame: 1.5 hours after oxytocin/placebo administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Natalie C Ebner, PhD principal investigator
University of Florida, Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin spray in people with Aging, run by University of Florida at 1 site in United States.
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 4 inclusion and 9 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 25 Aug 2016. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Extent of Trust Behavior (time frame: 45 minutes after drug/placebo administration). 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 25 Aug 2016.