Trial Outcomes & Findings for Oxytocin as Adjunctive Treatment of Schizophrenia (NCT NCT01568528)
NCT ID: NCT01568528
Last Updated: 2019-09-04
Results Overview
In order to assess the processing of social stimuli, subjects will be presented with a series of human faces of mixed sex and race showing neutral emotions and instructed to visually scan each face. Six regions of interest (ROIs) will be defined for each face stimulus: eyes, nose mouth, forehead, cheeks, and outside the contours of the face. The data will be processed off line for each face stimulus as the total time of fixation inside each of the ROIs. Refers to the number of fixations that occurred on the face of the stimulus presented to the participant during the eye-tracking assessment.
COMPLETED
PHASE2
39 participants
Day 1
2019-09-04
Participant Flow
Participants were recruited fom the Atlanta VA Medical Center in Atlanta, GA. Enrollment began in March 2013 and all study activities ended in March 15th, 2017. A total of 39 individuals were consented to participate in the study and passed screening, were randomly assigned to treatment arm and are included in the following results.
Two groups of participants were enrolled in the trial: Healthy controls and Schizophrenia subjects. The schizophrenia subjects were then randomized to either Oxytocin or Placebo. Note: for eye tracking and game outcomes, some subjects did not yield analyzable results due to the technical issues. Their data were therefore missing.
Participant milestones
| Measure |
Healthy Controls
Participants having no psychiatric diagnosis were controls for this project. These controls will not receive oxytocin or placebo. They will only receive psychiatric screening interview, MATRICS Consensus Cognitive Battery (MCCB) assessment, urine drug screen, vision testing, and the three social cognition tasks.
|
Oxytocin Arm
Participants receiving the intranasal oxytocin intervention received a dose of three 4 IU puffs per nostril for a total dose of 24 IU. Each puff is 0.1ml in volume so the total volume administered was 0.6 ml intranasally.
|
Placebo Arm
Participants receiving the intranasal placebo intervention consisting of the OT vehicle administered as three puffs in each nostril. Each puff is 0.1ml in volume so the total volume administered will be 0.6 ml intranasally.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
11
|
9
|
|
Overall Study
COMPLETED
|
19
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxytocin as Adjunctive Treatment of Schizophrenia
Baseline characteristics by cohort
| Measure |
Healthy Controls
n=19 Participants
Participants having no psychiatric diagnosis were controls for this project. These controls will not receive oxytocin or placebo. They will only receive psychiatric screening interview, MATRICS Consensus Cognitive Battery (MCCB) assessment, urine drug screen, vision testing, and the three social cognition tasks.
|
Oxytocin
n=11 Participants
Participants receiving the intranasal oxytocin intervention received a dose of three 4 IU puffs per nostril for a total dose of 24 IU. Each puff is 0.1ml in volume so the total volume administered was 0.6 ml intranasally.
|
Placebo
n=9 Participants
Participants receiving the intranasal placebo intervention consisting of the OT vehicle administered as three puffs in each nostril. Each puff is 0.1ml in volume so the total volume administered will be 0.6 ml intranasally.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.36 years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
50.82 years
STANDARD_DEVIATION 9.16 • n=7 Participants
|
47 years
STANDARD_DEVIATION 11.81 • n=5 Participants
|
50.21 years
STANDARD_DEVIATION 9.76 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
11 participants
n=7 Participants
|
9 participants
n=5 Participants
|
39 participants
n=4 Participants
|
|
PANSS negative
|
NA units on a scale
STANDARD_DEVIATION NA • n=5 Participants
|
13.64 units on a scale
STANDARD_DEVIATION 4.11 • n=7 Participants
|
13.55 units on a scale
STANDARD_DEVIATION 4.25 • n=5 Participants
|
13.6 units on a scale
STANDARD_DEVIATION 4.06 • n=4 Participants
|
|
PANSS positive
|
NA units on a scale
STANDARD_DEVIATION NA • n=5 Participants
|
12.09 units on a scale
STANDARD_DEVIATION 2.62 • n=7 Participants
|
11.55 units on a scale
STANDARD_DEVIATION 2.51 • n=5 Participants
|
11.85 units on a scale
STANDARD_DEVIATION 2.52 • n=4 Participants
|
|
PANSS total
|
NA units on a scale
STANDARD_DEVIATION NA • n=5 Participants
|
49.18 units on a scale
STANDARD_DEVIATION 8.15 • n=7 Participants
|
47.78 units on a scale
STANDARD_DEVIATION 7.41 • n=5 Participants
|
48.55 units on a scale
STANDARD_DEVIATION 7.65 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: The analysis includes participants for which valid measurements are available: 16 participants in the Healthy Control Group, 11 in the Oxytocin Group and 9 in the Placebo Group.
In order to assess the processing of social stimuli, subjects will be presented with a series of human faces of mixed sex and race showing neutral emotions and instructed to visually scan each face. Six regions of interest (ROIs) will be defined for each face stimulus: eyes, nose mouth, forehead, cheeks, and outside the contours of the face. The data will be processed off line for each face stimulus as the total time of fixation inside each of the ROIs. Refers to the number of fixations that occurred on the face of the stimulus presented to the participant during the eye-tracking assessment.
Outcome measures
| Measure |
Healthy Controls
n=16 Participants
Participants having no psychiatric diagnosis were controls for this project. These controls will not receive oxytocin or placebo. They will only receive psychiatric screening interview, MATRICS Consensus Cognitive Battery (MCCB) assessment, urine drug screen, vision testing, and the three social cognition tasks.
|
Oxytocin
n=11 Participants
Participants receiving the intranasal oxytocin intervention received a dose of three 4 IU puffs per nostril for a total dose of 24 IU. Each puff is 0.1ml in volume so the total volume administered was 0.6 ml intranasally.
|
Placebo
n=9 Participants
Participants receiving the intranasal placebo intervention consisting of the OT vehicle administered as three puffs in each nostril. Each puff is 0.1ml in volume so the total volume administered will be 0.6 ml intranasally.
|
|---|---|---|---|
|
Eye Tracking: Fixation Count
Eye Tracking-Gaze
|
6.78 Number of face fixations
Standard Deviation 3.74
|
9.19 Number of face fixations
Standard Deviation 4.86
|
9.88 Number of face fixations
Standard Deviation 4.83
|
|
Eye Tracking: Fixation Count
Eye Tracking-Gender
|
7.94 Number of face fixations
Standard Deviation 4.90
|
8.34 Number of face fixations
Standard Deviation 4.46
|
7.38 Number of face fixations
Standard Deviation 6.24
|
PRIMARY outcome
Timeframe: Day 1Population: The analysis includes participants for which valid measurements are available: 16 participants in the Healthy Control Group, 11 in the Oxytocin Group and 9 in the Placebo Group.
Refers to the amount of time that an individual spent looking at the face of the stimulus presented to the participant during the eye-tracking assessment.
Outcome measures
| Measure |
Healthy Controls
n=16 Participants
Participants having no psychiatric diagnosis were controls for this project. These controls will not receive oxytocin or placebo. They will only receive psychiatric screening interview, MATRICS Consensus Cognitive Battery (MCCB) assessment, urine drug screen, vision testing, and the three social cognition tasks.
|
Oxytocin
n=11 Participants
Participants receiving the intranasal oxytocin intervention received a dose of three 4 IU puffs per nostril for a total dose of 24 IU. Each puff is 0.1ml in volume so the total volume administered was 0.6 ml intranasally.
|
Placebo
n=9 Participants
Participants receiving the intranasal placebo intervention consisting of the OT vehicle administered as three puffs in each nostril. Each puff is 0.1ml in volume so the total volume administered will be 0.6 ml intranasally.
|
|---|---|---|---|
|
Eye Tracking: Dwell Duration Time
Eye-Tracking Gaze
|
1.11 milliseconds
Standard Deviation 0.75
|
1.01 milliseconds
Standard Deviation 0.57
|
1.18 milliseconds
Standard Deviation 0.52
|
|
Eye Tracking: Dwell Duration Time
Eye-Tracking Gender
|
1.26 milliseconds
Standard Deviation 0.64
|
1.04 milliseconds
Standard Deviation 0.66
|
0.99 milliseconds
Standard Deviation 0.78
|
PRIMARY outcome
Timeframe: Day 1Population: The analysis includes participants for which valid measurements are available: 16 participants in the Healthy Control Group, 11 in the Oxytocin Group and 9 in the Placebo Group.
Subjects will perform a computerized Social Reward Ball-Tossing Task in which they decide to return the ball to one of three fictional partners. The photos of the partners and their reciprocity in returning the ball to the subject will be manipulated. The number of balls sent to each of the partners will be quantified to assess socially reinforced learning. The result is expressed in number of ball tosses sent to the subject by a fictional player with a positive expression MINUS the number of ball tosses sent to the subject by a fictional player with a negative expression. These measures will be compared between the control subjects, oxytocin and placebo group.
Outcome measures
| Measure |
Healthy Controls
n=16 Participants
Participants having no psychiatric diagnosis were controls for this project. These controls will not receive oxytocin or placebo. They will only receive psychiatric screening interview, MATRICS Consensus Cognitive Battery (MCCB) assessment, urine drug screen, vision testing, and the three social cognition tasks.
|
Oxytocin
n=11 Participants
Participants receiving the intranasal oxytocin intervention received a dose of three 4 IU puffs per nostril for a total dose of 24 IU. Each puff is 0.1ml in volume so the total volume administered was 0.6 ml intranasally.
|
Placebo
n=9 Participants
Participants receiving the intranasal placebo intervention consisting of the OT vehicle administered as three puffs in each nostril. Each puff is 0.1ml in volume so the total volume administered will be 0.6 ml intranasally.
|
|---|---|---|---|
|
Social Reward Ball-tossing Task
|
8.91 Number of Ball tosses
Standard Deviation 22.68
|
15.38 Number of Ball tosses
Standard Deviation 29.19
|
25.64 Number of Ball tosses
Standard Deviation 39.59
|
PRIMARY outcome
Timeframe: Day 1Population: The analysis includes participants for which valid measurements are available: 16 participants in the Healthy Control Group, 11 in the Oxytocin Group and 9 in the Placebo Group.
Social reward trials will be interleaved with non-social trials where subjects will play with random geometric shapes or landscape scenes associated with positive and negative non-social rewards. The outcome measure reported herein is the number of ball tosses the subject sends to shape A minus the number of ball tosses sent to shape B.
Outcome measures
| Measure |
Healthy Controls
n=16 Participants
Participants having no psychiatric diagnosis were controls for this project. These controls will not receive oxytocin or placebo. They will only receive psychiatric screening interview, MATRICS Consensus Cognitive Battery (MCCB) assessment, urine drug screen, vision testing, and the three social cognition tasks.
|
Oxytocin
n=11 Participants
Participants receiving the intranasal oxytocin intervention received a dose of three 4 IU puffs per nostril for a total dose of 24 IU. Each puff is 0.1ml in volume so the total volume administered was 0.6 ml intranasally.
|
Placebo
n=9 Participants
Participants receiving the intranasal placebo intervention consisting of the OT vehicle administered as three puffs in each nostril. Each puff is 0.1ml in volume so the total volume administered will be 0.6 ml intranasally.
|
|---|---|---|---|
|
Non-Social Reward Ball-tossing Game
|
10.53 number of ball tosses
Standard Deviation 15.64
|
6.29 number of ball tosses
Standard Deviation 15.69
|
28.20 number of ball tosses
Standard Deviation 28.78
|
PRIMARY outcome
Timeframe: Day 1Population: The analysis includes participants for which valid measurements are available: 16 participants in the Healthy Control Group, 11 in the Oxytocin Group and 9 in the Placebo Group.
The stimuli are 19 standard black and white pictures of faces showing one of six different emotions (happy, sad, angry, surprise, disgusted, ashamed) that were developed by Ekman and Friesen (1976). The pictures are shown for 15 sec, with 10 sec between each face. After the presentation of each face the subject is asked to choose which of the six emotions was displayed. The score on the test is the sum of correct responses. Subjects in the two groups (oxytocin vs. placebo) will be compared.
Outcome measures
| Measure |
Healthy Controls
n=16 Participants
Participants having no psychiatric diagnosis were controls for this project. These controls will not receive oxytocin or placebo. They will only receive psychiatric screening interview, MATRICS Consensus Cognitive Battery (MCCB) assessment, urine drug screen, vision testing, and the three social cognition tasks.
|
Oxytocin
n=11 Participants
Participants receiving the intranasal oxytocin intervention received a dose of three 4 IU puffs per nostril for a total dose of 24 IU. Each puff is 0.1ml in volume so the total volume administered was 0.6 ml intranasally.
|
Placebo
n=9 Participants
Participants receiving the intranasal placebo intervention consisting of the OT vehicle administered as three puffs in each nostril. Each puff is 0.1ml in volume so the total volume administered will be 0.6 ml intranasally.
|
|---|---|---|---|
|
Facial Emotion Identification Task
|
12.16 Correct responses
Standard Deviation 2.63
|
11 Correct responses
Standard Deviation 3.58
|
9.44 Correct responses
Standard Deviation 4.10
|
Adverse Events
Healthy Controls
Oxytocin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place