Autism Spectrum DisordersPhase 2NCT01914939
A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder
A Phase 2 study testing Oxytocin, Social Skills focused CBT and Stress management/relaxation training in people with Autism Spectrum Disorders, run by Massachusetts General Hospital at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Oxytocin, Social Skills focused CBT and Stress management/relaxation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Massachusetts Institute of Technology Martinos Imaging Center
Cambridge, Massachusetts, 02139
About this study
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
- Being tested
- Oxytocin, Social Skills focused CBT, Stress management/relaxation training, placebo drug
- Keywords
- autism spectrum disorder, social skills deficits, cognitive behavioral therapy, oxytocin, young adult
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Social Skills focused CBTBehavioural
Stress management/relaxation trainingBehavioural
placebo drugDrug
| Study group | Role | What they receive |
|---|---|---|
| Social Skills Focused CBT | Experimental | Twelve weekly 60-minute sessions of social skills focused CBT Receives: Behavioral: Social Skills focused CBT |
| Stress Management/Relaxation Training | Active comparator | Twelve weekly 60-minute sessions of stress management training Receives: Behavioral: Stress management/relaxation training |
| Oxytocin | Experimental | Intranasal administration of 24 IU of oxytocin Receives: Drug: Oxytocin |
| placebo drug | Placebo comparator | Intranasal placebo drug Receives: Drug: placebo drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and after 12 weeks of treatment
Clinical Global Impression Scale (CGI)
Independent Evaluator rated measure of autism symptom severity and improvement
Measured: At baseline and every 4 week up to 12 weeks
Secondary outcomes (3)
Social Responsiveness Scale (SRS)
65-item rating scale that measures the severity of autism spectrum symptoms
Measured: At baseline and every 4 weeks up to 12 weeks
Reading the Mind in the Eyes Test (RMET)
Computerized measure of social skills
Measured: At baseline and every 4 weeks up to 12 weeks
Social Ball Tossing Task
Computerized measure of social skills
Measured: At baseline and every 4 weeks up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startApr 2014
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Responsible party
- Principal investigator, Aude Henin, Massachusetts General Hospital
- Investigators
- John Gabrieli, PhD, Principal investigator, Massachusetts General Hospital/MITAude Henin, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914939
- Sponsor's protocol ID
- W81XWH-12-1-0543
- Other IDs
- Clinical Trial Award
- Status last verified
- Jan 2020
- First submitted
- 29 Jul 2013
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37811711
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT01914939
- Acronym / sponsor ID
- W81XWH-12-1-0543
- Conditions
- Autism Spectrum Disorders
- Keywords
- autism spectrum disorder, social skills deficits, cognitive behavioral therapy, oxytocin, young adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- Apr 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 2 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Social Skills Focused CBT | Experimental | Behavioral: Social Skills focused CBTTwelve weekly 60-minute sessions of social skills focused CBT |
| Stress Management/Relaxation Training | Active comparator | Behavioral: Stress management/relaxation trainingTwelve weekly 60-minute sessions of stress management training |
| Oxytocin | Experimental | Drug: OxytocinIntranasal administration of 24 IU of oxytocin |
| placebo drug | Placebo comparator | Drug: placebo drugIntranasal placebo drug |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18-40
- Able to attend in person therapy sessions in Boston
- Male
- English-speaking
- Normal or corrected vision
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin | Drug | Oxytocin |
| Social Skills focused CBT | Behavioural | Social Skills Focused CBT |
| Stress management/relaxation training | Behavioural | Stress Management/Relaxation Training |
| placebo drug | Drug | placebo drug |
Primary outcome
Changes in the Autism Diagnostic Observation Schedule (ADOS)
Time frame: 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)
Time frame: At baseline and every 4 week up to 12 weeks
Independent Evaluator rated measure of autism symptom severity and improvement
3 secondary outcomes
Social Responsiveness Scale (SRS)
Time frame: At baseline and every 4 weeks up to 12 weeks
Reading the Mind in the Eyes Test (RMET)
Time frame: At baseline and every 4 weeks up to 12 weeks
Social Ball Tossing Task
Time frame: At baseline and every 4 weeks up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Derived from this study: PubMed 37811711Iffland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Gabrieli, PhD principal investigator
Massachusetts General Hospital/MIT
Aude Henin, PhD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin, Social Skills focused CBT and Stress management/relaxation training in people with Autism Spectrum Disorders, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Autism Diagnostic Observation Schedule (ADOS) (time frame: At baseline and after 12 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01914939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.