Clinical trial NCT01914939: A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder
Official title: A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism Spectrum Disorders
Keywords: autism spectrum disorder
social skills deficits
cognitive behavioral therapy
oxytocin
young adult
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Institute of Technology
First posted: 2013-08-02
Enrollment: 92
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in the Autism Diagnostic Observation Schedule (ADOS)
timeFrame: At baseline and after 12 weeks of treatment
measure: Clinical Global Impression Scale (CGI)
timeFrame: At baseline and every 4 week up to 12 weeks
Secondary outcomes:
measure: Social Responsiveness Scale (SRS)
timeFrame: At baseline and every 4 weeks up to 12 weeks
measure: Reading the Mind in the Eyes Test (RMET)
timeFrame: At baseline and every 4 weeks up to 12 weeks
measure: Social Ball Tossing Task
timeFrame: At baseline and every 4 weeks up to 12 weeks
Other outcomes:
measure: Self-Control Behavior Scale (SCBS)
timeFrame: At baseline and every 4 weeks up to 12 weeks
measure: Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
timeFrame: At baseline and every 4 weeks up to 12 weeks
measure: Social Phobia and Anxiety Inventory (SPAI)
timeFrame: At baseline and every 4 weeks up to 12 weeks
measure: Social Adjustment Scale (SAS)
timeFrame: At baseline and every 4 weeks up to 12 weeks
measure: Vineland Adaptive Behavior Scales, 2nd Edition
timeFrame: At baseline and every 4 weeks up to 12 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: At baseline and every 4 weeks up to 12 weeks
measure: Global Assessment of Functioning (GAF)
timeFrame: At baseline and every 4 weeks up to 12 weeks
measure: Safety Monitoring Uniform Report Form
timeFrame: At baseline and every 4 weeks up to 12 weeks
measure: Autism Diagnostic Interview-Revised (ADI-R)
timeFrame: Baseline
measure: Structured Clinical Interview for DSM-IV (SCID)
timeFrame: Baseline
measure: Wechsler Intelligence Scales (WASI and WAIS-III)
timeFrame: Baseline
measure: Care Utilization
timeFrame: At baseline and every 4 weeks up to 12 weeks
measure: Service Evaluation Questionnaire
timeFrame: After 12 weeks of treatment
measure: Participant Adherence to the Intervention
timeFrame: after 12 weeks of treatment
measure: Expectancy Rating Questionnaire
timeFrame: at week 1 of treatment
measure: Adaptive Behavioral Assessment Scale-3rd edition
timeFrame: at weeks, 1, 4, 8, and 12
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Cambridge
country: United States
facility: Massachusetts Institute of Technology Martinos Imaging Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital/MIT
name: John Gabrieli, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Aude Henin, PhD
role: PRINCIPAL_INVESTIGATOR
References: