An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders
|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: NCT01931033|
Recruitment Status : Active, not recruiting
First Posted : August 29, 2013
Last Update Posted : November 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders Pervasive Developmental Disorders ASD PDD||Drug: Intranasal Oxytocin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.
Drug: Intranasal Oxytocin
Other Name: Syntocinon
- Social Responsiveness Scale (SRS-2) [ Time Frame: Week-8 ]A 65-item rating scale completed by the secondary reporter used to measure the severity of autism spectrum symptoms as they occur in natural settings.
- Clinical Global Impression of PDD - Improvement (CGI-I) [ Time Frame: Week-8 ]The CGI is a measure of illness severity, improvement, and efficacy of treatment (National Institute of Mental Health, 1985). The score for Improvement ranges from 1 (very much improved) to 7 (very much worse).
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): NCT01931033
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Gagan Joshi, MD||Massachusetts General Hospital|