A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder
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|ClinicalTrials.gov Identifier: NCT02985749|
Recruitment Status : Active, not recruiting
First Posted : December 7, 2016
Last Update Posted : February 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder Pervasive Developmental Disorder ASD PDD||Drug: Intranasal Oxytocin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder|
|Actual Study Start Date :||October 9, 2017|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2019|
Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.
Drug: 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).
Other Name: Syntocinon
- Social Responsiveness Scale (SRS-2 School Age form and SRS-2 Adult Self-Report) [ Time Frame: 8 weeks ]A 65-item rating scale will be completed by the participant (ages 18-55) or the participant's parent/guardian (ages 6-17) to measure the severity of autism spectrum symptoms as they occur in natural settings.
- Quality of Life Enjoyment and Satisfaction (PQ-LES-Q and Q-LES-Q) [ Time Frame: 8 weeks ]A 15-item rating scale will be completed by the participant (ages 18-55) or the participant's parent/guardian (ages 6-17) to assess the quality of life from the subject's perspective.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985749
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Gagan Joshi, MD||Massachusetts General Hospital|