A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|