Trial Outcomes & Findings for Oxytocin and CBSST for People With Schizophrenia (NCT NCT01752712)
NCT ID: NCT01752712
Last Updated: 2019-09-25
Results Overview
Determine if CBSST + oxytocin compared to CBSST + placebo is associated with improved social function. There are 7 individual sections, with each section asking about different aspects of social functioning. Scores for Section 1: "Social Engagement Withdrawal" range from 0-15; Section 2: "Interpersonal Communication/Relationships" ranges from 0-30; Section 3: "Prosocial Activities" range is 0-66; Section 4: "Recreation" ranges from 0-48; Section 5: "Independence (Performance)" ranges from 0-39; Section 6: "Independence (Competence)" ranges from 0-39; and Section 7: "Occupation/Employment" ranges from 0-6 if the participant is unemployed or 7-10 if the participant is employed. The minimum value possible is 0 for participants who are unemployed and 7 for those with employment. The total BSFS score is calculated by adding the total scores from each of the 7 sections, with a maximum total score of 247. A lower total score indicates a lower social function rating.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
Treatment weeks 0, 12, and 24, plus follow-up week 36
Results posted on
2019-09-25
Participant Flow
83 participants signed a consent form for the study. 4 of these subjects were deemed ineligible before starting any study procedures, and 17 participants were withdrawn from the study prior to randomization for various reasons. Therefore, 62 subjects were randomized to a study treatment group (31 CBSST+oxytocin, 31 CBSST+placebo).
Participant milestones
| Measure |
CBSST + Oxytocin
Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).
CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
CBSST + Placebo
Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).
CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxytocin and CBSST for People With Schizophrenia
Baseline characteristics by cohort
| Measure |
CBSST + Oxytocin
n=31 Participants
Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).
CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
CBSST + Placebo
n=31 Participants
Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).
CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
41.92 years
STANDARD_DEVIATION 9.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 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
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment weeks 0, 12, and 24, plus follow-up week 36Population: Only participants who were enrolled in the study and had completed a BSFS assessment were analyzed at each study time point.
Determine if CBSST + oxytocin compared to CBSST + placebo is associated with improved social function. There are 7 individual sections, with each section asking about different aspects of social functioning. Scores for Section 1: "Social Engagement Withdrawal" range from 0-15; Section 2: "Interpersonal Communication/Relationships" ranges from 0-30; Section 3: "Prosocial Activities" range is 0-66; Section 4: "Recreation" ranges from 0-48; Section 5: "Independence (Performance)" ranges from 0-39; Section 6: "Independence (Competence)" ranges from 0-39; and Section 7: "Occupation/Employment" ranges from 0-6 if the participant is unemployed or 7-10 if the participant is employed. The minimum value possible is 0 for participants who are unemployed and 7 for those with employment. The total BSFS score is calculated by adding the total scores from each of the 7 sections, with a maximum total score of 247. A lower total score indicates a lower social function rating.
Outcome measures
| Measure |
CBSST + Oxytocin
n=31 Participants
Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).
CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
CBSST + Placebo
n=31 Participants
Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).
CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
|---|---|---|
|
Birchwood Social Function Scale (BSFS) Total Score
Treatment Week 0
|
120 units on a scale
Standard Deviation 23.1
|
115.8 units on a scale
Standard Deviation 21.4
|
|
Birchwood Social Function Scale (BSFS) Total Score
Treatment Week 12
|
120.8 units on a scale
Standard Deviation 21.9
|
127 units on a scale
Standard Deviation 21.8
|
|
Birchwood Social Function Scale (BSFS) Total Score
Treatment Week 24
|
125.3 units on a scale
Standard Deviation 20.3
|
126.4 units on a scale
Standard Deviation 17.4
|
|
Birchwood Social Function Scale (BSFS) Total Score
Follow-Up Week 36
|
124 units on a scale
Standard Deviation 20.2
|
125.8 units on a scale
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: Treatment weeks 0, 12, and 24, plus follow-up week 36Population: Only participants who were enrolled in the study and had completed a DPAS assessment were analyzed at each study time point.
Determine if CBSST + oxytocin compared to CBSST + placebo is associated with defeatist performance beliefs. The total DPAS score is calculated by adding the scores for scales #1-#18. Each scale ranges from "1=Agree Totally" to "7=Disagree Totally". Total scores range from a minimum score of 18 to a maximum score of 126. Reverse scoring was applied to make higher scores indicate a stronger defeatist attitude.
Outcome measures
| Measure |
CBSST + Oxytocin
n=31 Participants
Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).
CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
CBSST + Placebo
n=31 Participants
Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).
CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
|---|---|---|
|
Defeatist Performance Attitudes Scale (DPAS) Total Score
Treatment Week 0
|
68.55 units on a scale
Standard Deviation 19.23
|
67.87 units on a scale
Standard Deviation 15.31
|
|
Defeatist Performance Attitudes Scale (DPAS) Total Score
Treatment Week 12
|
71.22 units on a scale
Standard Deviation 19.38
|
66.92 units on a scale
Standard Deviation 14.23
|
|
Defeatist Performance Attitudes Scale (DPAS) Total Score
Treatment Week 24
|
73.50 units on a scale
Standard Deviation 18.07
|
72.65 units on a scale
Standard Deviation 16.80
|
|
Defeatist Performance Attitudes Scale (DPAS) Total Score
Follow-Up Week 36
|
77.14 units on a scale
Standard Deviation 18.25
|
72.37 units on a scale
Standard Deviation 16.85
|
SECONDARY outcome
Timeframe: Treatment weeks 0, 12, and 24, plus follow-up week 36Population: Only participants who were enrolled in the study and had completed a ABS assessment were analyzed at each study time point.
Determine if CBSST + oxytocin compared to CBSST + placebo is associated with asocial beliefs. The total ABS score is calculated by adding the scores for items #1-#15. Each scale is provided a True/False response, with True responses equaling 1 point and False responses equaling 0 points. In calculating the ABS total score, four of the 15 items of the ABS were reverse scored. A lower total score indicates more severe asocial beliefs.
Outcome measures
| Measure |
CBSST + Oxytocin
n=31 Participants
Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).
CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
CBSST + Placebo
n=31 Participants
Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).
CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
|---|---|---|
|
Asocial Belief Scale (ABS) Total Score
Treatment Week 0
|
6.8 units on a scale
Standard Deviation 3.6
|
5.5 units on a scale
Standard Deviation 2.5
|
|
Asocial Belief Scale (ABS) Total Score
Treatment Week 12
|
6.8 units on a scale
Standard Deviation 3.9
|
5.8 units on a scale
Standard Deviation 3.1
|
|
Asocial Belief Scale (ABS) Total Score
Treatment Week 24
|
6.4 units on a scale
Standard Deviation 2.8
|
5.2 units on a scale
Standard Deviation 3.1
|
|
Asocial Belief Scale (ABS) Total Score
Follow-Up Week 36
|
6.6 units on a scale
Standard Deviation 3.6
|
4.9 units on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Every 4 weeks during the treatment phase, plus follow-up week 36Population: Only participants who were enrolled in the study and had completed a SANS assessment were analyzed at each study time point.
SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.
Outcome measures
| Measure |
CBSST + Oxytocin
n=31 Participants
Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).
CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
CBSST + Placebo
n=31 Participants
Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).
CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
|---|---|---|
|
Schedule for Assessment of Negative Symptoms (SANS) Total Score
Treatment Week 0
|
28.5 units on a scale
Standard Deviation 12.5
|
35.9 units on a scale
Standard Deviation 12.5
|
|
Schedule for Assessment of Negative Symptoms (SANS) Total Score
Treatment Week 4
|
25.3 units on a scale
Standard Deviation 11.1
|
32.2 units on a scale
Standard Deviation 10.6
|
|
Schedule for Assessment of Negative Symptoms (SANS) Total Score
Treatment Week 8
|
26.5 units on a scale
Standard Deviation 10.9
|
30.8 units on a scale
Standard Deviation 10.3
|
|
Schedule for Assessment of Negative Symptoms (SANS) Total Score
Treatment Week 12
|
26.0 units on a scale
Standard Deviation 9.4
|
29.0 units on a scale
Standard Deviation 11.8
|
|
Schedule for Assessment of Negative Symptoms (SANS) Total Score
Treatment Week 16
|
27 units on a scale
Standard Deviation 8.5
|
30.7 units on a scale
Standard Deviation 14.0
|
|
Schedule for Assessment of Negative Symptoms (SANS) Total Score
Treatment Week 20
|
25.5 units on a scale
Standard Deviation 9.2
|
31.9 units on a scale
Standard Deviation 14.2
|
|
Schedule for Assessment of Negative Symptoms (SANS) Total Score
Treatment Week 24
|
27.5 units on a scale
Standard Deviation 9.5
|
31.2 units on a scale
Standard Deviation 11.2
|
|
Schedule for Assessment of Negative Symptoms (SANS) Total Score
Follow-Up Week 36
|
27.1 units on a scale
Standard Deviation 10
|
30.7 units on a scale
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: Every 4 weeks during the treatment phase, plus follow-up week 36Population: Only participants who were enrolled in the study and had completed a BPRS assessment were analyzed at each study time point.
The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.
Outcome measures
| Measure |
CBSST + Oxytocin
n=31 Participants
Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).
CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
CBSST + Placebo
n=31 Participants
Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).
CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS) Total Score
Treatment Week 0
|
38.2 units on a scale
Standard Deviation 8.2
|
40.0 units on a scale
Standard Deviation 10.4
|
|
Brief Psychiatric Rating Scale (BPRS) Total Score
Treatment Week 4
|
34.5 units on a scale
Standard Deviation 6.7
|
39.1 units on a scale
Standard Deviation 8.9
|
|
Brief Psychiatric Rating Scale (BPRS) Total Score
Treatment Week 8
|
33.5 units on a scale
Standard Deviation 8.8
|
38.6 units on a scale
Standard Deviation 9.2
|
|
Brief Psychiatric Rating Scale (BPRS) Total Score
Treatment Week 12
|
31.7 units on a scale
Standard Deviation 6.0
|
37.9 units on a scale
Standard Deviation 9.2
|
|
Brief Psychiatric Rating Scale (BPRS) Total Score
Treatment Week 16
|
30.5 units on a scale
Standard Deviation 4.8
|
36.7 units on a scale
Standard Deviation 10.5
|
|
Brief Psychiatric Rating Scale (BPRS) Total Score
Treatment Week 20
|
31.3 units on a scale
Standard Deviation 7.0
|
37.2 units on a scale
Standard Deviation 10.6
|
|
Brief Psychiatric Rating Scale (BPRS) Total Score
Treatment Week 24
|
33.7 units on a scale
Standard Deviation 7.0
|
37.8 units on a scale
Standard Deviation 9.8
|
|
Brief Psychiatric Rating Scale (BPRS) Total Score
Follow-Up Week 36
|
33.7 units on a scale
Standard Deviation 5.9
|
39.0 units on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Every 4 weeks during the treatment phase, plus follow-up week 36Population: Only participants who were enrolled in the study and had completed a BPRS assessment were analyzed at each study time point.
The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.
Outcome measures
| Measure |
CBSST + Oxytocin
n=31 Participants
Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).
CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
CBSST + Placebo
n=31 Participants
Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).
CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS) Psychosis Score
Treatment Week 0
|
10.4 units on a scale
Standard Deviation 4.9
|
11.7 units on a scale
Standard Deviation 6.0
|
|
Brief Psychiatric Rating Scale (BPRS) Psychosis Score
Treatment Week 4
|
9.7 units on a scale
Standard Deviation 4.3
|
12.2 units on a scale
Standard Deviation 5.7
|
|
Brief Psychiatric Rating Scale (BPRS) Psychosis Score
Treatment Week 8
|
8.8 units on a scale
Standard Deviation 3.7
|
12.9 units on a scale
Standard Deviation 5.5
|
|
Brief Psychiatric Rating Scale (BPRS) Psychosis Score
Treatment Week 12
|
7.7 units on a scale
Standard Deviation 3.4
|
12.1 units on a scale
Standard Deviation 5.0
|
|
Brief Psychiatric Rating Scale (BPRS) Psychosis Score
Treatment Week 16
|
7.5 units on a scale
Standard Deviation 3.0
|
11.0 units on a scale
Standard Deviation 5.8
|
|
Brief Psychiatric Rating Scale (BPRS) Psychosis Score
Treatment Week 20
|
8.3 units on a scale
Standard Deviation 3.8
|
10.5 units on a scale
Standard Deviation 5.7
|
|
Brief Psychiatric Rating Scale (BPRS) Psychosis Score
Treatment Week 24
|
9.3 units on a scale
Standard Deviation 3.9
|
11.2 units on a scale
Standard Deviation 5.4
|
|
Brief Psychiatric Rating Scale (BPRS) Psychosis Score
Follow-Up Week 36
|
8.8 units on a scale
Standard Deviation 4.0
|
11.1 units on a scale
Standard Deviation 5.2
|
Adverse Events
CBSST + Oxytocin
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
CBSST + Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CBSST + Oxytocin
n=31 participants at risk
Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).
CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
CBSST + Placebo
n=31 participants at risk
Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).
CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
|---|---|---|
|
General disorders
Hospitalization
|
3.2%
1/31 • Number of events 1 • Weekly for 24 weeks
Reportable adverse events (AEs) are defined as any harm experienced by a study participant, which in the opinion of the investigator is unexpected and probably related to the research procedures. None of our AEs met these criteria. Participants are systematically monitored for any increases the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline.
|
0.00%
0/31 • Weekly for 24 weeks
Reportable adverse events (AEs) are defined as any harm experienced by a study participant, which in the opinion of the investigator is unexpected and probably related to the research procedures. None of our AEs met these criteria. Participants are systematically monitored for any increases the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline.
|
|
Psychiatric disorders
Hospitalization
|
3.2%
1/31 • Number of events 1 • Weekly for 24 weeks
Reportable adverse events (AEs) are defined as any harm experienced by a study participant, which in the opinion of the investigator is unexpected and probably related to the research procedures. None of our AEs met these criteria. Participants are systematically monitored for any increases the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline.
|
0.00%
0/31 • Weekly for 24 weeks
Reportable adverse events (AEs) are defined as any harm experienced by a study participant, which in the opinion of the investigator is unexpected and probably related to the research procedures. None of our AEs met these criteria. Participants are systematically monitored for any increases the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline.
|
Other adverse events
| Measure |
CBSST + Oxytocin
n=31 participants at risk
Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).
CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
CBSST + Placebo
n=31 participants at risk
Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).
CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
|
|---|---|---|
|
General disorders
Dry mouth
|
0.00%
0/31 • Weekly for 24 weeks
Reportable adverse events (AEs) are defined as any harm experienced by a study participant, which in the opinion of the investigator is unexpected and probably related to the research procedures. None of our AEs met these criteria. Participants are systematically monitored for any increases the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline.
|
6.5%
2/31 • Number of events 2 • Weekly for 24 weeks
Reportable adverse events (AEs) are defined as any harm experienced by a study participant, which in the opinion of the investigator is unexpected and probably related to the research procedures. None of our AEs met these criteria. Participants are systematically monitored for any increases the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline.
|
|
Ear and labyrinth disorders
Dizziness
|
0.00%
0/31 • Weekly for 24 weeks
Reportable adverse events (AEs) are defined as any harm experienced by a study participant, which in the opinion of the investigator is unexpected and probably related to the research procedures. None of our AEs met these criteria. Participants are systematically monitored for any increases the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline.
|
3.2%
1/31 • Number of events 1 • Weekly for 24 weeks
Reportable adverse events (AEs) are defined as any harm experienced by a study participant, which in the opinion of the investigator is unexpected and probably related to the research procedures. None of our AEs met these criteria. Participants are systematically monitored for any increases the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline.
|
|
General disorders
Nasal irritation
|
3.2%
1/31 • Number of events 1 • Weekly for 24 weeks
Reportable adverse events (AEs) are defined as any harm experienced by a study participant, which in the opinion of the investigator is unexpected and probably related to the research procedures. None of our AEs met these criteria. Participants are systematically monitored for any increases the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline.
|
3.2%
1/31 • Number of events 1 • Weekly for 24 weeks
Reportable adverse events (AEs) are defined as any harm experienced by a study participant, which in the opinion of the investigator is unexpected and probably related to the research procedures. None of our AEs met these criteria. Participants are systematically monitored for any increases the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline.
|
|
General disorders
Headache
|
0.00%
0/31 • Weekly for 24 weeks
Reportable adverse events (AEs) are defined as any harm experienced by a study participant, which in the opinion of the investigator is unexpected and probably related to the research procedures. None of our AEs met these criteria. Participants are systematically monitored for any increases the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline.
|
3.2%
1/31 • Number of events 3 • Weekly for 24 weeks
Reportable adverse events (AEs) are defined as any harm experienced by a study participant, which in the opinion of the investigator is unexpected and probably related to the research procedures. None of our AEs met these criteria. Participants are systematically monitored for any increases the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline.
|
|
Psychiatric disorders
Anxiety
|
6.5%
2/31 • Number of events 3 • Weekly for 24 weeks
Reportable adverse events (AEs) are defined as any harm experienced by a study participant, which in the opinion of the investigator is unexpected and probably related to the research procedures. None of our AEs met these criteria. Participants are systematically monitored for any increases the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline.
|
0.00%
0/31 • Weekly for 24 weeks
Reportable adverse events (AEs) are defined as any harm experienced by a study participant, which in the opinion of the investigator is unexpected and probably related to the research procedures. None of our AEs met these criteria. Participants are systematically monitored for any increases the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline.
|
Additional Information
Robert W. Buchanan, M.D.
Maryland Psychiatric Research Center
Phone: 410-402-7876
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place