Clinical trial NCT01823146: Oxytocin's Effect on Socioemotional Aging
Official title: Oxytocin and Aging: Neuro-Behavioral Effects on Social Cognition and Prosocial Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: oxytocin
socioemotional functioning
trust
amygdala
aging
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Extent of Trust Behavior
timeFrame: 45 minutes after drug/placebo administration
Secondary outcomes:
measure: Meta-Mood
timeFrame: 2.5 hours after drug/placebo administration
measure: Functional Connectivity (Resting fMRI)
timeFrame: 1.5 hours after oxytocin/placebo administration
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida, Department of Psychology
name: Natalie C Ebner, PhD
role: PRINCIPAL_INVESTIGATOR
References: