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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Aging
Interventions Drug: Oxytocin spray
Drug: Placebo spray
Enrollment 106
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.
Pre-assignment Details  
Arm/Group Title Oxytocin Spray Placebo Spray
Hide 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
Reason Not Completed
Withdrawal by Subject             0             1
Lost to Follow-up             2             1
Arm/Group Title Oxytocin Spray Placebo Spray Total
Hide 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 Number of Baseline Participants 55 51 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 51 participants 106 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
34
  61.8%
26
  51.0%
60
  56.6%
>=65 years
21
  38.2%
25
  49.0%
46
  43.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 51 participants 106 participants
Female
28
  50.9%
27
  52.9%
55
  51.9%
Male
27
  49.1%
24
  47.1%
51
  48.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants 51 participants 106 participants
55 51 106
1.Primary Outcome
Title Extent of Trust Behavior
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 53 49
Mean (Standard Error)
Unit of Measure: monetary units
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 53 49
Mean (Standard Error)
Unit of Measure: units on a scale
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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 40 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: z-scores
0.58
(0.49 to 0.66)
0.48
(0.39 to 0.57)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxytocin Spray Placebo Spray
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oxytocin Spray Placebo Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/51 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oxytocin Spray Placebo Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/51 (0.00%) 
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.
Results Point of Contact
Name/Title: Dr. Natalie Ebner
Organization: University of Florida
Phone: 203 691 0371
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 Submitted: March 25, 2013
First Posted: April 4, 2013
Results First Submitted: June 24, 2015
Results First Posted: September 17, 2015
Last Update Posted: August 25, 2016