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

Autism Spectrum Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914939
• Other study ID #: W81XWH-12-1-0543
• Secondary ID: Clinical Trial A
• Status: Completed
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: November 2017

Study information

• Verified date: January 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

Drug:
• Oxytocin

Behavioral:
• Social Skills focused CBT

• Stress management/relaxation training

Drug:
• placebo drug

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Massachusetts Institute of Technology Martinos Imaging Center	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Massachusetts Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-Control Behavior Scale (SCBS)	Self-report questionnaire of coping and problem-solving skills	At baseline and every 4 weeks up to 12 weeks
Other	Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)	Self-report questionnaire of psychosocial functioning	At baseline and every 4 weeks up to 12 weeks
Other	Social Phobia and Anxiety Inventory (SPAI)	Self-report questionnaire of social anxiety	At baseline and every 4 weeks up to 12 weeks
Other	Social Adjustment Scale (SAS)	Self-report and parent-rated measure of psychosocial functioning	At baseline and every 4 weeks up to 12 weeks
Other	Vineland Adaptive Behavior Scales, 2nd Edition	Measure of adaptive and functional behaviors	At baseline and every 4 weeks up to 12 weeks
Other	Beck Depression Inventory (BDI)	Self-report questionnaire of depression symptoms	At baseline and every 4 weeks up to 12 weeks
Other	Global Assessment of Functioning (GAF)	Overall rating of impairment	At baseline and every 4 weeks up to 12 weeks
Other	Safety Monitoring Uniform Report Form	Assessment of adverse effects associated with oxytocin or placebo	At baseline and every 4 weeks up to 12 weeks
Other	Autism Diagnostic Interview-Revised (ADI-R)	Parent-report, clinician-administered assessment of autism spectrum disorder symptoms in their child	Baseline
Other	Structured Clinical Interview for DSM-IV (SCID)	A semistructured, clinician-administered assessment that assesses the presence of major psychiatric disorders. It is administered to the participant and to a parent about the participant.	Baseline
Other	Wechsler Intelligence Scales (WASI and WAIS-III)	Measures of current intellectual functioning. Will be used to assess inclusion/exclusion criteria.	Baseline
Other	Care Utilization	Assessment of any treatments (including medications, naturopathic treatments, speech or occupational therapy, hospitalizations, and intensive day programs) received over the past month.	At baseline and every 4 weeks up to 12 weeks
Other	Service Evaluation Questionnaire	Self-report questionnaire about the participant's satisfaction with the psychosocial treatment they received.	After 12 weeks of treatment
Other	Participant Adherence to the Intervention	Information will be collected about a) the number of sessions attended by each participant; b) completion of homework assignments; and c) participation in the treatment sessions, using a 0-5 scale	after 12 weeks of treatment
Other	Expectancy Rating Questionnaire	Brief, self-report questionnaire about the participant's expectations of and belief in the social skills or stress management/relaxation interventions presented in the first session.	at week 1 of treatment
Other	Adaptive Behavioral Assessment Scale-3rd edition	self-report measure of adaptive functioning	at weeks, 1, 4, 8, and 12
Primary	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
Primary	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	Social Responsiveness Scale (SRS)	65-item rating scale that measures the severity of autism spectrum symptoms	At baseline and every 4 weeks up to 12 weeks
Secondary	Reading the Mind in the Eyes Test (RMET)	Computerized measure of social skills	At baseline and every 4 weeks up to 12 weeks
Secondary	Social Ball Tossing Task	Computerized measure of social skills	At baseline and every 4 weeks up to 12 weeks