Trial Outcomes & Findings for Oxytocin Treatment of Schizophrenia (NCT NCT01028677)
NCT ID: NCT01028677
Last Updated: 2017-04-18
Results Overview
The Emotion Recognition-40 (ER-40; Kohler, Turner, Gur, \& Gur, 2004) consists of a series of 40 faces, shown one at a time on a computer screen. Participants choose the correct emotions based on 5 answer choices: happy, sad, anger, fear and no emotion. Participants indicate the word that best describes the emotion each faces expresses. The stimuli are presented in a randomized order each time they are administered. A scoring program automatically records accuracy and median response time. Range for each emotion (score range) is 0 (no correct responses) to 8 (all faces on each emotion category are correctly identified). The ER-40 faces were derived from the University of Pennsylvania Emotion Recognition Task, 96 faces version, and are balanced for equality and intensity of emotion, age, gender and ethnicity.
COMPLETED
NA
17 participants
6 weeks
2017-04-18
Participant Flow
Participant milestones
| Measure |
Intranasal Spray With Oxytocin
Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks
|
Intranasal Spray Without Oxytocin
Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
7
|
|
Overall Study
COMPLETED
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxytocin Treatment of Schizophrenia
Baseline characteristics by cohort
| Measure |
Intranasal Spray With Oxytocin
n=8 Participants
Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks
|
Intranasal Spray Without Oxytocin
n=6 Participants
Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.88 years
STANDARD_DEVIATION 7.22 • n=5 Participants
|
35.67 years
STANDARD_DEVIATION 9.00 • n=7 Participants
|
37.50 years
STANDARD_DEVIATION 7.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe Emotion Recognition-40 (ER-40; Kohler, Turner, Gur, \& Gur, 2004) consists of a series of 40 faces, shown one at a time on a computer screen. Participants choose the correct emotions based on 5 answer choices: happy, sad, anger, fear and no emotion. Participants indicate the word that best describes the emotion each faces expresses. The stimuli are presented in a randomized order each time they are administered. A scoring program automatically records accuracy and median response time. Range for each emotion (score range) is 0 (no correct responses) to 8 (all faces on each emotion category are correctly identified). The ER-40 faces were derived from the University of Pennsylvania Emotion Recognition Task, 96 faces version, and are balanced for equality and intensity of emotion, age, gender and ethnicity.
Outcome measures
| Measure |
Intranasal Spray With Oxytocin
n=8 Participants
Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks
|
Intranasal Spray Without Oxytocin
n=6 Participants
Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks
|
|---|---|---|
|
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point
Fear
|
7.25 number of correct responses
Standard Deviation .89
|
6.67 number of correct responses
Standard Deviation 1.86
|
|
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point
Anger
|
4.38 number of correct responses
Standard Deviation 1.30
|
6.17 number of correct responses
Standard Deviation 1.72
|
|
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point
Sad
|
7.13 number of correct responses
Standard Deviation 1.46
|
6.50 number of correct responses
Standard Deviation 1.64
|
|
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point
Happy
|
8.00 number of correct responses
Standard Deviation .00
|
7.83 number of correct responses
Standard Deviation .41
|
|
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point
Neutral
|
7.25 number of correct responses
Standard Deviation .89
|
7.17 number of correct responses
Standard Deviation .98
|
PRIMARY outcome
Timeframe: 6 weeksThe Eyes Test (Baron-Cohen, Wheelwright, Hill, Raste, \& Plumb, 2001) consists of 36 photographs where participants are asked to guess the mental state (i.e., what the person is thinking or feeling) from among four choice words. Participants are given a practice item to ensure that they understand the task. Each eye region is displayed on a computer screen with the four choice mental states shown in the four corners of the computer screen (one target word and three foil words). The score range is 0 (no correct responses) to 36 (all stimuli are correctly identified).
Outcome measures
| Measure |
Intranasal Spray With Oxytocin
n=8 Participants
Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks
|
Intranasal Spray Without Oxytocin
n=6 Participants
Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks
|
|---|---|---|
|
Theory of Mind as Measured by the Eyes Test at 6 Weeks
|
22.25 correct responses
Standard Deviation 5.29
|
22.17 correct responses
Standard Deviation 7.83
|
PRIMARY outcome
Timeframe: 6 weeksIn The Brune Test (Brune, 2003), participants are shown a series of six sets of four cartoon pictures that illustrate interactions between two or more individuals. The cartoon cards were displayed to the participant in a predetermined scrambled order. Participants are asked to rearrange the pictures in an order that conveys a logical story. After the participant arranges the cards, the examiner ensures they are in the correct sequence. If they are not in the correct order, the examiner silently arranges them so they are in the logical sequence.The participant's interpretations of the characters' beliefs are scored as correct or incorrect (zero or one), with higher scores indicating better Theory of Mind. The sum of correct answers is the outcome of interest. The participants can receive a maximum total of 23 points for the questions.
Outcome measures
| Measure |
Intranasal Spray With Oxytocin
n=8 Participants
Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks
|
Intranasal Spray Without Oxytocin
n=6 Participants
Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks
|
|---|---|---|
|
Theory of Mind as Measured by the Brune Test at 6 Weeks
|
21.13 correct responses
Standard Deviation 1.36
|
22.00 correct responses
Standard Deviation 1.27
|
PRIMARY outcome
Timeframe: 6 weeksThe Trustworthiness Task (Adolphs, Tranel, \& Damasio, 1998) is comprised of 42 black and white photographs of the faces of unfamiliar people. Participants are shown each picture individually (on a computer monitor) and asked to rate how much they would trust that person (e.g., with their money) on a seven-point scale, ranging from -3 (very untrustworthy) to +3 (very trustworthy). They are provided with a photograph of 0 or an average face (i.e., someone they would neither trust nor distrust) to refer to throughout the task (based on Adolphs et al.'s, 1998 norms). The total score is the sum of the trustworthiness ratings. Possible range is -126 to 126.
Outcome measures
| Measure |
Intranasal Spray With Oxytocin
n=8 Participants
Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks
|
Intranasal Spray Without Oxytocin
n=6 Participants
Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks
|
|---|---|---|
|
Social Perception as Measured by the Trustworthiness Task at 6 Weeks
|
1.88 rating on a scale
Standard Deviation 40.98
|
11.33 rating on a scale
Standard Deviation 34.23
|
PRIMARY outcome
Timeframe: 6 weeksThe Interpersonal Reactivity Index (IRI; Davis, 1983) is a self-report measure of cognitive and affective empathy. The IRI consists of 28 items where participants rate how well each item describes them using a five-point scale (1 to 5). The 28 items yield four subscales: perspective taking (PT), empathic concern (EC), fantasy (F), and personal distress (PD). Higher scores indicate a greater empathic response. Score range for IRI: min, max Total: 28, 140 PT: 7, 35 EC: 7, 35 F: 7, 35 PD: 7, 35
Outcome measures
| Measure |
Intranasal Spray With Oxytocin
n=5 Participants
Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks
|
Intranasal Spray Without Oxytocin
n=5 Participants
Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks
|
|---|---|---|
|
Empathy as Measured by the Interpersonal Reactivity Index (IRI) at 6 Weeks
Total Score
|
88.00 rating on a scale
Standard Deviation 13.71
|
87.00 rating on a scale
Standard Deviation 8.57
|
|
Empathy as Measured by the Interpersonal Reactivity Index (IRI) at 6 Weeks
Fantasy
|
21.60 rating on a scale
Standard Deviation 4.62
|
26.80 rating on a scale
Standard Deviation 6.26
|
|
Empathy as Measured by the Interpersonal Reactivity Index (IRI) at 6 Weeks
Emotional Empathy
|
23.80 rating on a scale
Standard Deviation 4.82
|
23.60 rating on a scale
Standard Deviation 6.88
|
|
Empathy as Measured by the Interpersonal Reactivity Index (IRI) at 6 Weeks
Perspective Taking
|
23.40 rating on a scale
Standard Deviation 2.51
|
19.40 rating on a scale
Standard Deviation 8.26
|
|
Empathy as Measured by the Interpersonal Reactivity Index (IRI) at 6 Weeks
Distress
|
19.20 rating on a scale
Standard Deviation 4.09
|
17.20 rating on a scale
Standard Deviation 4.32
|
SECONDARY outcome
Timeframe: 6 weeksThe PANSS consists of 30 items (7 positive psychotic symptoms, 7 negative psychotic symptoms, 16 general psychopathology symptoms) on which subjects are rated (1-7) based upon a semi-standardized interview. Higher scores indicate more/greater symptoms (i.e., greater symptoms of psychosis) and lower scores indicate fewer symptoms (better outcome). Possible score range: min, max Total: 30,210 Positive symptoms:7, 49 Negative symptoms:7, 49 General symptoms: 16,112
Outcome measures
| Measure |
Intranasal Spray With Oxytocin
n=8 Participants
Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks
|
Intranasal Spray Without Oxytocin
n=6 Participants
Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks
|
|---|---|---|
|
Clinical Psychiatric Symptoms as Measured by Positive and Negative Syndrome Scale (PANSS) at 6 Weeks
Positive Symptoms
|
14.00 rating on a scale
Standard Deviation 3.34
|
18.50 rating on a scale
Standard Deviation 6.22
|
|
Clinical Psychiatric Symptoms as Measured by Positive and Negative Syndrome Scale (PANSS) at 6 Weeks
Negative Symptoms
|
17.25 rating on a scale
Standard Deviation 4.20
|
17.17 rating on a scale
Standard Deviation 3.66
|
|
Clinical Psychiatric Symptoms as Measured by Positive and Negative Syndrome Scale (PANSS) at 6 Weeks
General Symptoms
|
29.88 rating on a scale
Standard Deviation 4.91
|
32.67 rating on a scale
Standard Deviation 4.13
|
Adverse Events
Intranasal Spray With Oxytocin
Intranasal Spray Without Oxytocin
Serious adverse events
| Measure |
Intranasal Spray With Oxytocin
n=10 participants at risk
Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks
|
Intranasal Spray Without Oxytocin
n=7 participants at risk
Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks
|
|---|---|---|
|
Psychiatric disorders
Serious Adverse Events
|
0.00%
0/10
|
0.00%
0/7
|
Other adverse events
| Measure |
Intranasal Spray With Oxytocin
n=10 participants at risk
Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks
|
Intranasal Spray Without Oxytocin
n=7 participants at risk
Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks
|
|---|---|---|
|
Vascular disorders
low blood pressure due to blood-draw
|
10.0%
1/10 • Number of events 1
|
0.00%
0/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place