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

Phase 2

Completed

• Conditions: Autism Spectrum Disorders
• Interventions: Drug: placebo drug; Behavioral: Social Skills focused CBT; Behavioral: Stress management/relaxation training; Drug: Oxytocin

• Registration Number: NCT01914939
• Lead Sponsor: Massachusetts General Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-29
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-02
• Study Start: 2014-04
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 92

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo drug	placebo drug	Intranasal placebo drug
Social Skills Focused CBT	Social Skills focused CBT	Twelve weekly 60-minute sessions of social skills focused CBT
Stress Management/Relaxation Training	Stress management/relaxation training	Twelve weekly 60-minute sessions of stress management training
Oxytocin	Oxytocin	Intranasal administration of 24 IU of oxytocin

Primary Outcome Measures

Name	Time	Method
Changes in the Autism Diagnostic Observation Schedule (ADOS)	At baseline and after 12 weeks of treatment	The ADOS is a semi-structured standardized assessment of communication and social interaction that is considered a gold-standard assessment of autism spectrum disorders. The study will use Module 4, designed for use with adolescents and adults. The primary endpoint(dependent measure) will be the change in a global impression of social engagement by a clinician who is an experienced ADOS administrator. This will be a rating on a 10-point scale and involve expert clinical judgement of the qualities and behaviors that are at the core of the social/communicative deficits.
Clinical Global Impression Scale (CGI)	At baseline and every 4 week up to 12 weeks	Independent Evaluator rated measure of autism symptom severity and improvement

Secondary Outcome Measures

Name	Time	Method
Social Responsiveness Scale (SRS)	At baseline and every 4 weeks up to 12 weeks	65-item rating scale that measures the severity of autism spectrum symptoms
Reading the Mind in the Eyes Test (RMET)	At baseline and every 4 weeks up to 12 weeks	Computerized measure of social skills
Social Ball Tossing Task	At baseline and every 4 weeks up to 12 weeks	Computerized measure of social skills

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Massachusetts Institute of Technology Martinos Imaging Center; 🇺🇸 Cambridge, Massachusetts, United States