Trial Outcomes & Findings for A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder (NCT NCT02985749)
NCT ID: NCT02985749
Last Updated: 2024-07-01
Results Overview
Change in ASD symptoms as measured by change from baseline on the Social Responsiveness Scale 2 (SRS-2) scale. The SRS-2 is a 65-item rating scale completed that is used to measure the severity of autism spectrum symptoms as they occur in natural settings. The SRS-2 School Age form is completed by a parent or guardian for patients ages 9-17 and the SRS-2 Adult Self-report is completed by patients ages 18-59. Total raw scores range from 0 to 195, with higher scores indicating increased symptom severity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
7 participants
Primary outcome timeframe
8 weeks
Results posted on
2024-07-01
Participant Flow
Participant milestones
| Measure |
Oxytocin- Participants Ages 12-17
Participants ages 12-17 enrolled to receive oxytocin treatment
Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.
Intranasal Oxytocin: This study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD).
|
Oxytocin- Participants Ages 18-55
Participants ages 18-55 enrolled to receive oxytocin treatment
Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.
Intranasal Oxytocin: This study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD).
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
5
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder
Baseline characteristics by cohort
| Measure |
Oxytocin- Participants Ages 12-17
n=2 Participants
Participants ages 12-17 enrolled to receive oxytocin treatment
Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.
Intranasal Oxytocin: This study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD).
|
Oxytocin- Participants Ages 18-55
n=5 Participants
Participants ages 18-55 enrolled to receive oxytocin treatment
Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.
Intranasal Oxytocin: This study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD).
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 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
|
13.5 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
30.0 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
25.3 years
STANDARD_DEVIATION 10.0 • 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
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksChange in ASD symptoms as measured by change from baseline on the Social Responsiveness Scale 2 (SRS-2) scale. The SRS-2 is a 65-item rating scale completed that is used to measure the severity of autism spectrum symptoms as they occur in natural settings. The SRS-2 School Age form is completed by a parent or guardian for patients ages 9-17 and the SRS-2 Adult Self-report is completed by patients ages 18-59. Total raw scores range from 0 to 195, with higher scores indicating increased symptom severity.
Outcome measures
| Measure |
Oxytocin- Participants Ages 12-17
n=2 Participants
Participants ages 12-17 enrolled to receive oxytocin treatment
Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.
Intranasal Oxytocin: This study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD).
|
Oxytocin- Participants Ages 18-55
n=3 Participants
Participants ages 18-55 enrolled to receive oxytocin treatment
Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.
Intranasal Oxytocin: This study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD).
|
|---|---|---|
|
Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale From Baseline to Week 8
|
-39.5 scores on a scale
Standard Deviation 12
|
-29 scores on a scale
Standard Deviation 9.8
|
Adverse Events
Oxytocin- Participants Ages 12-17
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Oxytocin- Participants Ages 18-55
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxytocin- Participants Ages 12-17
n=2 participants at risk
Participants ages 12-17 enrolled to receive oxytocin treatment
Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.
Intranasal Oxytocin: This study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD).
|
Oxytocin- Participants Ages 18-55
n=5 participants at risk
Participants ages 18-55 enrolled to receive oxytocin treatment
Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.
Intranasal Oxytocin: This study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD).
|
|---|---|---|
|
Ear and labyrinth disorders
Ear infection
|
0.00%
0/2 • 8 weeks (from baseline to end of study)
|
20.0%
1/5 • Number of events 3 • 8 weeks (from baseline to end of study)
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
0.00%
0/2 • 8 weeks (from baseline to end of study)
|
20.0%
1/5 • Number of events 1 • 8 weeks (from baseline to end of study)
|
|
Nervous system disorders
Faint/dizzy after blood drawn
|
0.00%
0/2 • 8 weeks (from baseline to end of study)
|
20.0%
1/5 • Number of events 1 • 8 weeks (from baseline to end of study)
|
|
Nervous system disorders
Drowsiness
|
0.00%
0/2 • 8 weeks (from baseline to end of study)
|
20.0%
1/5 • Number of events 1 • 8 weeks (from baseline to end of study)
|
|
Immune system disorders
Allergy
|
50.0%
1/2 • Number of events 1 • 8 weeks (from baseline to end of study)
|
0.00%
0/5 • 8 weeks (from baseline to end of study)
|
|
Psychiatric disorders
Increased sex drive
|
0.00%
0/2 • 8 weeks (from baseline to end of study)
|
20.0%
1/5 • Number of events 1 • 8 weeks (from baseline to end of study)
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/2 • 8 weeks (from baseline to end of study)
|
20.0%
1/5 • Number of events 1 • 8 weeks (from baseline to end of study)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place