Trial Outcomes & Findings for An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders (NCT NCT01931033)

NCT ID: NCT01931033

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: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: Week-8
• Results posted on: 2024-07-01

Participant Flow

Participant milestones

Measure	Participants Ages 11-17 Participants ages 11-17 enrolled to receive oxytocin treatment
Overall Study STARTED	8
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders

Baseline characteristics by cohort

Measure	Participants Ages 11-17 n=8 Participants Participants ages 11-17 enrolled to receive oxytocin treatment
Age, Categorical <=18 years	8 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week-8

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.

Outcome measures

Measure	Participants Ages 11-17 n=5 Participants Participants ages 11-17 enrolled to receive oxytocin treatment
Change in ASD Symptoms Social Responsiveness Scales 2 (SRS-2) Scales From Baseline to Week 8	-32.4 scores on a scale Standard Deviation 17.25688

PRIMARY outcome

Timeframe: Week-8

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. The Clinical Global Impression Improvement scale (CGI-ASD-I) is a clinician rated measure of ASD improvement. Improvement scores range from 1 (very much improved) to 7 (very much worse).

Outcome measures

Measure	Participants Ages 11-17 n=5 Participants Participants ages 11-17 enrolled to receive oxytocin treatment
Number of Participants With ≥30% Reduction in SRS Raw Score and CGI Improvement Scores of ≤ 2 at Week 8	2 Participants

Adverse Events

Participants Ages 11-17

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Participants Ages 11-17 n=8 participants at risk Participants ages 11-17 enrolled to receive oxytocin treatment
General disorders Nasal Irritation	12.5% 1/8 • Number of events 2 • 8 weeks (from baseline to end of study)
General disorders Restlessness	12.5% 1/8 • Number of events 1 • 8 weeks (from baseline to end of study)
Psychiatric disorders Mental Fatigue	12.5% 1/8 • Number of events 5 • 8 weeks (from baseline to end of study)
Psychiatric disorders Anxiety	12.5% 1/8 • Number of events 1 • 8 weeks (from baseline to end of study)
General disorders Headache	12.5% 1/8 • Number of events 2 • 8 weeks (from baseline to end of study)
General disorders Lump in Throat	12.5% 1/8 • Number of events 1 • 8 weeks (from baseline to end of study)
Nervous system disorders Tightness in Fingers	12.5% 1/8 • Number of events 1 • 8 weeks (from baseline to end of study)

Additional Information

Gagan Joshi, MD

Massachusetts General Hospital

Phone: 617-726-1541

Email: gjoshi@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place