Trial Outcomes & Findings for Effects of Oxytocin Nasal Spray on Social Affiliation (NCT NCT00663039)

NCT ID: NCT00663039

Last Updated: 2019-09-09

Results Overview

In a videotaped session, research staff engages the participant in social interaction based on a role play. The tape is rated on social skills and on Positive and Negative Affect Scale. Participants are rated on a 5 point Likert scale ranging from very poor (1) to Very Good (5).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: 30 minutes
• Results posted on: 2019-09-09

Participant Flow

Participant milestones

Measure	Oxytocin, Then Placebo Participants first received 24IU of Oxytocin administered intranasally with 6 total sprays (three in each nostril) on the morning and at midday of one study visit. Then, after at least month the participants returned for a second study day and received placebo.	Placebo, Then Oxytocin Participants first received a placebo (saline nasal spray) administered intranasally with 6 total sprays (three in each nostril) on the morning and at midday of one study visit. Then, after at least month the participants returned for a second study day and received Oxytocin.
Overall Study STARTED	14	13
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Oxytocin Nasal Spray on Social Affiliation

Baseline characteristics by cohort

Measure	All Study Participants n=27 Participants Participants who were screened and met inclusion/exclusion criteria for the study.
Age, Continuous	51.9 years STANDARD_DEVIATION 10.54 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes

Population: Of the 27 ppts that were screened and deemed eligible for study participation, only 19 completed testing while receiving oxytocin and only 18 complete testing while receiving placebo.

In a videotaped session, research staff engages the participant in social interaction based on a role play. The tape is rated on social skills and on Positive and Negative Affect Scale. Participants are rated on a 5 point Likert scale ranging from very poor (1) to Very Good (5).

Outcome measures

Measure	Oxytocin n=19 Participants Oxytocin Oxytocin: 24 IU oxytocin in a total of 6 puffs (3 puffs per nostril) administer at two intervals during 1 study visit.	Placebo n=18 Participants Placebo: Single dose (plus a booster dose) drug probe study using intranasal placebo
Social Affiliation Measured by Social Affiliative Role Play Overall Affect	4.026 units on a scale Standard Deviation 0.656	4.111 units on a scale Standard Deviation 0.583
Social Affiliation Measured by Social Affiliative Role Play Overall Social Skill	4.079 units on a scale Standard Deviation 0.854	4.194 units on a scale Standard Deviation 0.622

SECONDARY outcome

Timeframe: 15 minutes

Population: Analyzable data for secondary outcomes was not available for some participants.

HVLT comes in 6 different forms. Forms 4 and 5 were used for this study with one form administered on the first study day and the other on the second and were counterbalanced between subjects. Each form contains 12 nouns, four words each from one of three semantic categories, to be learned over the course of three learning trials.

Outcome measures

Measure	Oxytocin n=16 Participants Oxytocin Oxytocin: 24 IU oxytocin in a total of 6 puffs (3 puffs per nostril) administer at two intervals during 1 study visit.	Placebo n=14 Participants Placebo: Single dose (plus a booster dose) drug probe study using intranasal placebo
Hopkins Verbal Learning Test (HVLT) Hopkins Verbal Learning Test Trial1	6.19 Number of correct responses Standard Deviation 2.23	6.57 Number of correct responses Standard Deviation 1.79
Hopkins Verbal Learning Test (HVLT) Hopkins Verbal Learning Test Trial2	8.56 Number of correct responses Standard Deviation 1.93	9.36 Number of correct responses Standard Deviation 1.78
Hopkins Verbal Learning Test (HVLT) Hopkins Verbal Learning Test Trial3	10.12 Number of correct responses Standard Deviation 2.03	10.57 Number of correct responses Standard Deviation 1.40

SECONDARY outcome

Timeframe: 20 minutes

Population: Analyzable data for secondary outcomes was not available for some participants.

Participants competed in a social trust game in which they are paired with a partner (the computer program). Over the course of 24 rounds the participant can offer up to $10 to their partner. The partner can either accept the offer, in which case the total amount offered is split equally between the participant and their partner (i.e. $10 is split into $5 each). Or the partner can reject the offer and receive an portion of the total offer for themselves and give the participant nothing ($0). The total amount of money that can be offered ranges from $0-240.

Outcome measures

Measure	Oxytocin n=16 Participants Oxytocin Oxytocin: 24 IU oxytocin in a total of 6 puffs (3 puffs per nostril) administer at two intervals during 1 study visit.	Placebo n=14 Participants Placebo: Single dose (plus a booster dose) drug probe study using intranasal placebo
Trust Game	112.5 Dollars Standard Deviation 60	134.5 Dollars Standard Deviation 68.5

SECONDARY outcome

Timeframe: 25 minutes

Population: Analyzable data for secondary outcomes was not available for some participants.

Rapid Visual Information Processing (RVIP) measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600milliseconds; the subjects respond when they see a target sequence of 3 odds or 3 even digits in a consecutive sequence. Two target sequences are separated by a minimum of 5 and maximum of 30 non-target digits

Outcome measures

Measure	Oxytocin n=16 Participants Oxytocin Oxytocin: 24 IU oxytocin in a total of 6 puffs (3 puffs per nostril) administer at two intervals during 1 study visit.	Placebo n=14 Participants Placebo: Single dose (plus a booster dose) drug probe study using intranasal placebo
RVIP Reaction Times RVIP Practice Mean Target Reaction Time	563 milliseconds Standard Deviation 103	586 milliseconds Standard Deviation 110
RVIP Reaction Times RVIP First Half Mean Target Reaction Time	588 milliseconds Standard Deviation 104.7	574.4 milliseconds Standard Deviation 82.9
RVIP Reaction Times RVIP Practice Mean False Alarms Reaction Time	306.9 milliseconds Standard Deviation 49.5	277.1 milliseconds Standard Deviation 104.4
RVIP Reaction Times RVIP First Half Mean False Alarms Reaction Time	302 milliseconds Standard Deviation 115	228 milliseconds Standard Deviation 138

SECONDARY outcome

Timeframe: 25 minutes

Population: Analyzable data for secondary outcomes was not available for some participants.

RVIP measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600ms; the subjects respond when they see a target sequence of 3 odds or 3 even digits in a consecutive sequence. Two target sequences are separated by a minimum of 5 and maximum of 30 non-target digits. There are a total of 48 target sequences during each test block. The number of correctly Identified target sequences or hits is recorded, as well as, false alarms (incorrectly identified target sequences) and reaction times.

Outcome measures

Measure	Oxytocin n=16 Participants Oxytocin Oxytocin: 24 IU oxytocin in a total of 6 puffs (3 puffs per nostril) administer at two intervals during 1 study visit.	Placebo n=14 Participants Placebo: Single dose (plus a booster dose) drug probe study using intranasal placebo
Rapid Visual Information Processing Test (RVIP) RVIP Practice Mean Target Hits	16.40 Number of responses Standard Deviation 8.58	19.15 Number of responses Standard Deviation 7.45
Rapid Visual Information Processing Test (RVIP) RVIP First Half Mean Target Hits	17.80 Number of responses Standard Deviation 6.52	21.62 Number of responses Standard Deviation 6.99
Rapid Visual Information Processing Test (RVIP) RVIP Practice Mean False Alarms	15.9 Number of responses Standard Deviation 16.5	10.2 Number of responses Standard Deviation 12.0
Rapid Visual Information Processing Test (RVIP) RVIP First Half Mean False Alarms	14.7 Number of responses Standard Deviation 19.4	12.2 Number of responses Standard Deviation 15.5

SECONDARY outcome

Timeframe: 5 minutes

Population: Analyzable data for secondary outcomes was not available for some participants.

The BACS Symbol Coding subtest will be used to assess processing speed, and the demographically corrected T score, will be used for data analysis. This test requires less than 5 minutes to administer and provides a highly reliable measure of processing speed. There are nine symbols code 1 through 9. Participants are given 90 seconds to match a series of these symbols with their corresponding number. The total correct matches is the participants score. Scores range from 0-110.

Outcome measures

Measure	Oxytocin n=16 Participants Oxytocin Oxytocin: 24 IU oxytocin in a total of 6 puffs (3 puffs per nostril) administer at two intervals during 1 study visit.	Placebo n=14 Participants Placebo: Single dose (plus a booster dose) drug probe study using intranasal placebo
Brief Assessments of Cognition for Schizophrenia	45.6 Number of correct responses Standard Deviation 13.8	47.7 Number of correct responses Standard Deviation 14.3

SECONDARY outcome

Timeframe: 5 minutes

Population: Analyzable data for secondary outcomes was not available for some participants.

The Brief Smell Identification Test (B-SIT) is a 5-minute, 12-item screening test. Participants try to identify 12 different odors with four multiple choice options given for each odor.

Outcome measures

Measure	Oxytocin n=16 Participants Oxytocin Oxytocin: 24 IU oxytocin in a total of 6 puffs (3 puffs per nostril) administer at two intervals during 1 study visit.	Placebo n=14 Participants Placebo: Single dose (plus a booster dose) drug probe study using intranasal placebo
Brief Smell Identification Test	10.06 Number of correct responses Standard Deviation 1.53	10.14 Number of correct responses Standard Deviation 1.10

SECONDARY outcome

Timeframe: 10 minutes

Population: Analyzable data for secondary outcomes was not available for some participants.

A 30 item task presents a picture of a person's eyes and the participant is ask to determine the person's mental state from 4 multiple choice options.

Outcome measures

Measure	Oxytocin n=16 Participants Oxytocin Oxytocin: 24 IU oxytocin in a total of 6 puffs (3 puffs per nostril) administer at two intervals during 1 study visit.	Placebo n=14 Participants Placebo: Single dose (plus a booster dose) drug probe study using intranasal placebo
Reading the Mind in the Eyes	24.40 Number of correct responses Standard Deviation 6.06	24.54 Number of correct responses Standard Deviation 5.78

SECONDARY outcome

Timeframe: 10 minutes

Population: Analyzable data for secondary outcomes was not available for some participants.

This computer administered test includes 40 color photographs of four universal emotions (happy, sad, angry, and fearful) balanced for the posers gender, age, and ethnicity, including four low intensity and four high-intensity facial expressions of each emotion, plus 8 neutral faces. The stimuli are presented in random order and subjects are asked to identify which stimuli were presented to them at the end. Performance on this test correlates with negative symptom severity.

Outcome measures

Measure	Oxytocin n=16 Participants Oxytocin Oxytocin: 24 IU oxytocin in a total of 6 puffs (3 puffs per nostril) administer at two intervals during 1 study visit.	Placebo n=14 Participants Placebo: Single dose (plus a booster dose) drug probe study using intranasal placebo
Facial Affect Recognition Facial Affect Recognition Total	29.79 Number of responses Standard Deviation 4.69	34.08 Number of responses Standard Deviation 5.33
Facial Affect Recognition Facial Affect Recognition Hits	12.86 Number of responses Standard Deviation 5.36	15.46 Number of responses Standard Deviation 4.22
Facial Affect Recognition Facial Affect Recognition False Alarms	6.71 Number of responses Standard Deviation 4.51	5.38 Number of responses Standard Deviation 3.01

Adverse Events

Oxytocin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Oxytocin n=19 participants at risk Oxytocin administered on study	Placebo n=18 participants at risk Placebo administered on study day
General disorders Dizziness	5.3% 1/19 • Number of events 1 • Collected over the course of 2 approximately 8 hour study days. The Side Effect Checklist was used	0.00% 0/18 • Collected over the course of 2 approximately 8 hour study days. The Side Effect Checklist was used
General disorders Drowsiness	5.3% 1/19 • Number of events 1 • Collected over the course of 2 approximately 8 hour study days. The Side Effect Checklist was used	0.00% 0/18 • Collected over the course of 2 approximately 8 hour study days. The Side Effect Checklist was used
General disorders Euphoria	5.3% 1/19 • Number of events 1 • Collected over the course of 2 approximately 8 hour study days. The Side Effect Checklist was used	0.00% 0/18 • Collected over the course of 2 approximately 8 hour study days. The Side Effect Checklist was used

Additional Information

Elliot Hong

MPRC

Phone: 410-402-6828

Email: ehong@mprc.umaryland.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place