Oxytocin's Effect on Socioemotional Aging

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT01823146
• Collaborator: (none)
• Enrollment: 106
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 7.6

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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: Jul 1, 2013
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Extent of Trust Behavior [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 [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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32611-2250

Sponsors and Collaborators

• University of Florida

Investigators

• Principal Investigator: Natalie C Ebner, PhD, University of Florida, Department of Psychology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT01823146
• Other Study ID Numbers: 39-2013; UL1TR000064
• First Posted: Apr 4, 2013
• Last Update Posted: Aug 25, 2016
• Last Verified: Oct 1, 2015

• Keywords provided by University of Florida: oxytocin; socioemotional functioning; trust; amygdala; aging
• Additional relevant MeSH terms: Oxytocin

Study Results

Participant Flow

Recruitment Details	Participants were recruited between 08/2013 and 09/2014. Recruitment phone calls were conducted at the Social-Cognitive and Affective Development Lab at University of Florida.

Arm/Group Title	Oxytocin Spray	Placebo Spray
Arm/Group Description	single dose of 24 IU oxytocin, self-administered intranasally (IN)	single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
Period Title: Overall Study
STARTED	55	51
COMPLETED	53	49
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Oxytocin Spray	Placebo Spray	Total
Arm/Group Description	single dose of 24 IU oxytocin, self-administered intranasally (IN)	single dose of 24 IU saline, self-administered intranasally (IN)	Total of all reporting groups
Overall Participants	55	51	106
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	34 61.8%	26 51%	60 56.6%
>=65 years	21 38.2%	25 49%	46 43.4%
Sex: Female, Male (Count of Participants)
Female	28 50.9%	27 52.9%	55 51.9%
Male	27 49.1%	24 47.1%	51 48.1%
Region of Enrollment (participants) [Number]
United States	55 100%	51 100%	106 100%

Outcome Measures

1. Primary Outcome

Title	Extent of Trust Behavior
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.
Time Frame	45 minutes after drug/placebo administration

Outcome Measure Data

Analysis Population Description

All study participants who had undergone the screening as well as the full visit (n = 102).

Arm/Group Title	Oxytocin Spray	Placebo Spray
Arm/Group Description	single dose of 24 IU oxytocin, self-administered intranasally (IN)	single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
Measure Participants	53	49
non-social trials	39.03 (2.55)	44.42 (2.54)
social trials	45.11 (1.86)	46.06 (2.47)

2. Secondary Outcome

Title	Meta-Mood
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.
Time Frame	2.5 hours after drug/placebo administration

Outcome Measure Data

Analysis Population Description

All study participants who had undergone the screening as well as the full visit (n = 102).

Arm/Group Title	Oxytocin Spray	Placebo Spray
Arm/Group Description	single dose of 24 IU oxytocin, self-administered intranasally (IN)	single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
Measure Participants	53	49
n = 24 older men (63 to 85 years)	3.38 (.18)	2.977 (.19)
n = 30 older women (63 to 85 years)	3.23 (.18)	3.63 (.17)
n = 25 young men (18 to 30 years)	3.54 (.17)	3.58 (.20)
n = 23 young women (18 to 30 years)	4.04 (.19)	3.68 (.21)

3. Secondary Outcome

Title	Functional Connectivity (Resting fMRI)
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.
Time Frame	1.5 hours after oxytocin/placebo administration

Outcome Measure Data

Analysis Population Description

All study participants who had undergone the screening as well as the full visit and had reliable resting fMRI scan data (e.g., low extent of head motion) (n = 79).

Arm/Group Title	Oxytocin Spray	Placebo Spray
Arm/Group Description	single dose of 24 IU oxytocin, self-administered intranasally (IN)	single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
Measure Participants	40	39
Least Squares Mean (95% Confidence Interval) [z-scores]	0.58	0.48

Adverse Events

Time Frame	1 year
Arm/Group Title	Oxytocin Spray		Placebo Spray
Arm/Group Description	single dose of 24 IU oxytocin, self-administered intranasally (IN) Oxytocin spray: single dose of 24 IU oxytocin, self-administered intranasally (IN)		single dose of 24 IU saline, self-administered intranasally (IN) Placebo spray: single dose of 24 IU saline, self-administered intranasally (IN)
All Cause Mortality
	Oxytocin Spray		Placebo Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Oxytocin Spray		Placebo Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Oxytocin Spray		Placebo Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/51 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.