Trial Outcomes & Findings for Does Acute Oxytocin Administration Enhance Social Cognition in Individuals With Schizophrenia? (NCT NCT01312272)
NCT ID: NCT01312272
Last Updated: 2014-05-02
Results Overview
Our primary outcome measure will be a composite score created by calculating the mean of the four main social cognition measures assessed in this study (two "high-level" measures and two "low-level" measures). Because these measures are not on the same scale, we will first z-score (center and scale) each of the four measures at each time point using the baseline mean and standard deviation of the whole sample and then calculate the mean of the z-scores to create the composite social cognition score.
COMPLETED
NA
24 participants
Visit 2 (baseline), Visit 3 (1 week following, post-treatment)
2014-05-02
Participant Flow
Participant milestones
| Measure |
Inactive Nasal Spray
A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time.
|
Intranasal Oxytocin
Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does Acute Oxytocin Administration Enhance Social Cognition in Individuals With Schizophrenia?
Baseline characteristics by cohort
| Measure |
Inactive Nasal Spray
n=12 Participants
A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time.
|
Intranasal Oxytocin
n=11 Participants
Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
48.6 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 2 (baseline), Visit 3 (1 week following, post-treatment)Our primary outcome measure will be a composite score created by calculating the mean of the four main social cognition measures assessed in this study (two "high-level" measures and two "low-level" measures). Because these measures are not on the same scale, we will first z-score (center and scale) each of the four measures at each time point using the baseline mean and standard deviation of the whole sample and then calculate the mean of the z-scores to create the composite social cognition score.
Outcome measures
| Measure |
Inactive Nasal Spray
n=12 Participants
A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time.
|
Intranasal Oxytocin
n=11 Participants
Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time
|
|---|---|---|
|
Social Cognition Composite Measure
|
0.10 Change in z-score
Standard Deviation 0.35
|
0.23 Change in z-score
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Visit 2 (baseline), Visit 3 (1 week following, post-treatment)The Awareness of Social Inference Test (TASIT Part III: Social Inference - Enriched) will be administered to assess theory of mind.
Outcome measures
| Measure |
Inactive Nasal Spray
n=12 Participants
A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time.
|
Intranasal Oxytocin
n=11 Participants
Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time
|
|---|---|---|
|
Theory of Mind Assessment (High Level Social Cognition)
|
-0.01 Change in z-score
Standard Deviation 0.47
|
0.18 Change in z-score
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Visit 2 (baseline), Visit 3 (1 week following, post-treatment)Empathy was assessed using the Emotional Perspective Taking Task (EPTT) (Derntl et al., 2009). In this task, subjects are presented with 60 digital images depicting two individuals in a social interaction, with one individual's face masked. Subjects are asked to infer the emotional expression of the masked face, selecting between two choices. Scenes portray 5 basic emotions as well as neutrality and each image is displayed for 4 s each.
Outcome measures
| Measure |
Inactive Nasal Spray
n=12 Participants
A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time.
|
Intranasal Oxytocin
n=11 Participants
Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time
|
|---|---|---|
|
Empathy
|
0.24 Change in z-score
Standard Deviation 0.63
|
0.61 Change in z-score
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Visit 2 (baseline), Visit 3 (1 week following, post-treatment)We will assess social perception using the Half-Profile of Nonverbal Sensitivity (Half-PONS). Brief scenes are shown that include facial expressions, voice intonations, and/or body gestures. Subjects select a label that best describes the situation. The dependent measure is the total number of correct labels.
Outcome measures
| Measure |
Inactive Nasal Spray
n=12 Participants
A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time.
|
Intranasal Oxytocin
n=11 Participants
Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time
|
|---|---|---|
|
Social Perception Assessment (Low Level Social Cognition)
|
0.15 Change in z-score
Standard Deviation 0.77
|
0 Change in z-score
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: Visit 2 (baseline), Visit 3 (1 week following, post-treatment)Participants are asked to identify facial expressions of emotion in still photographs from the standardized stimulus set developed by Ekman. The test includes digitized color photos of eight different posers displaying facial expressions of six basic emotions plus neutral expressions. On each trial, a photo and a list of the seven possible expressions are simultaneously presented on the screen. The participant verbally identifies the emotion he/she believes is correct and the experimenter enters the response. The dependent measure is the total number correct.
Outcome measures
| Measure |
Inactive Nasal Spray
n=12 Participants
A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time.
|
Intranasal Oxytocin
n=11 Participants
Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time
|
|---|---|---|
|
Facial Affect Recognition (Low Level Social Cognition)
|
0.05 Change in z-score
Standard Deviation 0.67
|
0.22 Change in z-score
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: Visit 2 (baseline), Visit 3 (1 week following, post-treatment)This is a frequently used instrument, initially developed by Kay, Opler, and Fiszbein, that assesses 30 different symptoms (categorized into positive, negative, and general psychopathology) on a scale from 1 to 7, based on clinical interview. It will be used to compare the psychopathology between the two treatment groups. The maximum Total Score on the scale is 210 and the minimum score is 30, with higher values indicating more severe symptoms. The maximum scale of 210 is the sum of the scores from each symptom category (positive symptoms = range 7 to 49; negative symptoms = range 7 to 49; general psychopathology = range to 16 to 112). Our outcome measure refers to the change in the PANSS Total Score. A greater decrease on the scale indicates greater improvement in symptoms (e.g., a participant with a change score of -20 improved more on the PANSS than a participant with a change score of -5).
Outcome measures
| Measure |
Inactive Nasal Spray
n=12 Participants
A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time.
|
Intranasal Oxytocin
n=11 Participants
Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time
|
|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS) for Schizophrenia Total Score
|
-10.83 change in units on scale
Standard Deviation 5.37
|
-8.89 change in units on scale
Standard Deviation 6.19
|
Adverse Events
Inactive Nasal Spray
Intranasal Oxytocin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Inactive Nasal Spray
n=12 participants at risk
A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.
Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time.
|
Intranasal Oxytocin
n=11 participants at risk
Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.
Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
8.3%
1/12 • 1 year, 1 month.
|
0.00%
0/11 • 1 year, 1 month.
|
|
Respiratory, thoracic and mediastinal disorders
Mild nasal tingling/irritation
|
8.3%
1/12 • 1 year, 1 month.
|
9.1%
1/11 • 1 year, 1 month.
|
|
Nervous system disorders
Drowsiness
|
0.00%
0/12 • 1 year, 1 month.
|
9.1%
1/11 • 1 year, 1 month.
|
Additional Information
Dr. Michael C. Davis
VISN 22 Mental Illness Research, Education, and Clinical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place