Trial · Interventional

CompletedNot applicableResults postedRegistry data

Oxytocin's Effect on Socioemotional Aging

NCTNCT01823146Other id39-2013Other idUL1TR000064

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Overview

Status: Completed
Phase: Not applicable
Enrollment: 106 participants (actual)
Sponsor: University of Florida · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Jul 2013
Primary completion: Sept 2014
Completion: Sept 2014
First posted: 4 Apr 2013 (estimated)
Last update posted: 25 Aug 2016 (estimated)
Conditions: Aging

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201320142015

N/A
Oxytocin's Effect on Socioemotional Aging
NCT01823146
Jul 2013 to Sept 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Oxytocin sprayDrug
Placebo sprayDrug

Arms2

Experimental
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)

Primary outcomes1

Outcomes the sponsor listed as primary.

Extent of Trust Behavior
Time frame · 45 minutes after drug/placebo administration
Registry description
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 outcomes(2)

Meta-Mood
Time frame · 2.5 hours after drug/placebo administration
Registry description
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.
Functional Connectivity (Resting fMRI)
Time frame · 1.5 hours after oxytocin/placebo administration
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 45 minutes after drug/placebo administration

Extent of Trust Behavior

Group	Value (monetary units)	Spread
Oxytocin Spray	39.03	2.55
Placebo Spray	44.42	2.54

Secondary and other outcome results(2)

Secondary outcomeMean· 2.5 hours after drug/placebo administration

Meta-Mood

Group	Value (units on a scale)	Spread
Oxytocin Spray	3.38	.18
Placebo Spray	2.977	.19

Secondary outcomeLeast squares mean· 1.5 hours after oxytocin/placebo administration

Functional Connectivity (Resting fMRI)

Group	Value (z-scores)
Oxytocin Spray	0.58
Placebo Spray	0.48

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Oxytocin Spraysingle dose of 24 IU oxytocin, self-administered intranasally (IN) Oxytocin spray: single dose of 24 IU oxytocin, self-administered intranasally (IN)	–	0 / 55	0 / 55
Placebo Spraysingle dose of 24 IU saline, self-administered intranasally (IN) Placebo spray: single dose of 24 IU saline, self-administered intranasally (IN)	–	0 / 51	0 / 51

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 85 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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