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

NCT01914939 | Completed Phase 2 DMC

• 2 other identifiers: W81XWH-12-1-0543Clinical Trial Award
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorders

Keywords

autism spectrum disorder; social skills deficits; cognitive behavioral therapy; oxytocin; young adult

Outcome Measures

Primary Outcomes (2)

• Changes in the Autism Diagnostic Observation Schedule (ADOS)

  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.

  At baseline and after 12 weeks of treatment

• Clinical Global Impression Scale (CGI)

  Independent Evaluator rated measure of autism symptom severity and improvement

  At baseline and every 4 week up to 12 weeks

Secondary Outcomes (3)

• Social Responsiveness Scale (SRS)

  At baseline and every 4 weeks up to 12 weeks

• Reading the Mind in the Eyes Test (RMET)

  At baseline and every 4 weeks up to 12 weeks

• Social Ball Tossing Task

  At baseline and every 4 weeks up to 12 weeks

Other Outcomes (16)

• Self-Control Behavior Scale (SCBS)

  At baseline and every 4 weeks up to 12 weeks

• Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

  At baseline and every 4 weeks up to 12 weeks

• Social Phobia and Anxiety Inventory (SPAI)

  At baseline and every 4 weeks up to 12 weeks

Study Arms (4)

Social Skills Focused CBT

EXPERIMENTAL

Twelve weekly 60-minute sessions of social skills focused CBT

Behavioral: Social Skills focused CBT

Stress Management/Relaxation Training

ACTIVE COMPARATOR

Twelve weekly 60-minute sessions of stress management training

Behavioral: Stress management/relaxation training

Oxytocin

EXPERIMENTAL

Intranasal administration of 24 IU of oxytocin

Drug: Oxytocin

placebo drug

PLACEBO COMPARATOR

Intranasal placebo drug

Drug: placebo drug

Interventions

Oxytocin DRUG

Oxytocin

Social Skills focused CBT BEHAVIORAL

Social Skills Focused CBT

Stress management/relaxation training BEHAVIORAL

Stress Management/Relaxation Training

placebo drug DRUG

placebo drug

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Presence of metal implants or other metal in the body
• History of claustrophobia or inability to tolerate MRI

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Massachusetts Institute of Technology: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Massachusetts Institute of Technology Martinos Imaging Center

Cambridge, Massachusetts, 02139, United States

Location

Related Publications (1)

• Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

  PMID: 37811711 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Oxytocin; Relaxation Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• John Gabrieli, PhD

  Massachusetts General Hospital/MIT

  PRINCIPAL INVESTIGATOR

• Aude Henin, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Child CBT Program

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: August 2, 2013
• Study Start: April 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

US (2)