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Oxytocin's Effect on Socioemotional Aging

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ClinicalTrials.gov Identifier: NCT01823146
Recruitment Status : Completed
First Posted : April 4, 2013
Results First Posted : September 17, 2015
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Aging Drug: Oxytocin spray Drug: Placebo spray Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Oxytocin and Aging: Neuro-Behavioral Effects on Social Cognition and Prosocial Behavior
Study Start Date : July 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin spray
single dose of 24 IU oxytocin, self-administered intranasally (IN)
Drug: Oxytocin spray
single dose of 24 IU oxytocin, self-administered intranasally (IN)

Placebo Comparator: Placebo spray
single dose of 24 IU placebo (same solution as oxytocin spray but without oxytocin), self-administered intranasally (IN)
Drug: Placebo spray
single dose of 24 IU placebo (same solution as oxytocin spray but without oxytocin), self-administered intranasally (IN)




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Meta-Mood [ Time Frame: 2.5 hours after drug/placebo administration ]
    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.

  2. Functional Connectivity (Resting fMRI) [ Time Frame: 1.5 hours after oxytocin/placebo administration ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between the ages of 18-30 years or 63-85 years
  • English fluency
  • Caucasian
  • Right-handed

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823146


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32611-2250
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Natalie C Ebner, PhD University of Florida, Department of Psychology

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01823146     History of Changes
Other Study ID Numbers: 39-2013
UL1TR000064 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2013    Key Record Dates
Results First Posted: September 17, 2015
Last Update Posted: August 25, 2016
Last Verified: October 2015

Keywords provided by University of Florida:
oxytocin
socioemotional functioning
trust
amygdala
aging

Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs