NCT01914939

A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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 to receive either a social skills-focused CBT intervention or a stress management/relaxation training CBT intervention. Participants will also be randomized to receive either a) intranasal oxytocin or b) a placebo drug, prior to the psychotherapy. The design of the study will enable examination of the efficacy of CBT for young adults with autism spectrum disorders. The design of the study will also allow examination of whether oxytocin enhances the efficacy of CBT. The investigators will perform functional (fMRI) and structural (MRI) imaging with all participants prior to treatment. This will enable examination of the relations between measures of brain function and structure, and improvements in target symptoms over the course of treatment. The aim is to discover whether there are neural characteristics that can identify which participants with autism spectrum disorders are most likely to respond to CBT interventions and/or oxytocin treatment.

Conditions

• Autism Spectrum Disorders

Interventions

Type	Name	Description
DRUG	Oxytocin
BEHAVIORAL	Social Skills focused CBT
BEHAVIORAL	Stress management/relaxation training
DRUG	placebo drug

Timeline

• Start date: 2014-04-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2013-08-02
• Last updated: 2020-01-27

Locations

2 sites across 1 country: United States