Status:
COMPLETED
A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Massachusetts Institute of Technology
Conditions:
Autism Spectrum Disorders
Eligibility:
MALE
18-40 years
Phase:
PHASE2
Brief Summary
This 3-year study is a trial of cognitive behavioral therapy (CBT), with or without oxytocin (OT) augmentation, in young adults with autism spectrum disorders. Participants will be randomly assigned t...
Eligibility Criteria
Inclusion
- Age 18-40
- Able to attend in person therapy sessions in Boston
- Male
- English-speaking
- Normal or corrected vision
- No history of known genetic disorder, significant motor developmental difficulties, prematurity or brain injury
- IQ \> 90, as determined by the WASI
- Score above the cutoff on the Reciprocal Social Interactions and the Restricted, Repetitive, and Stereotyped Behaviors Domains on the ADI-R, meet criteria for PDD or autism on the ADOS, and/or meet DSM-IV criteria for Autism Spectrum Disorder according to clinician interview.
Exclusion
- Current use of certain endocrinologically relevant medications
- Current dependence on substances other than tobacco or caffeine
- History of serious medical illness, including neurological, endocrine, cardiac, respiratory, and metabolic diseases that are counter-indications to oxytocin
- Severe, current psychiatric disorder (ie, current mania, severe depression, psychosis, suicidality, severe aggression)
- Long QT, as determined by baseline EKG
- Current participation in other psychotherapy
- Additional exclusion criteria for MRI scan only:
- Participants who are MRI-ineligible will be enrolled in the clinical trial portion of the study, but will not undergo the MRI scan at MIT. Exclusion criteria for MRI are:
- Presence of metal implants or other metal in the body
- History of claustrophobia or inability to tolerate MRI
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01914939
Start Date
April 1 2014
End Date
November 1 2017
Last Update
January 27 2020
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Massachusetts Institute of Technology Martinos Imaging Center
Cambridge, Massachusetts, United States, 02139