Autism Spectrum DisorderPhase 3NCT02985749
A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder
A Phase 3 study testing Intranasal Oxytocin in people with Autism Spectrum Disorder and Pervasive Developmental Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study is an 8-week pilot trial with oxytocin nasal spray (Syntocinon) as a treatment for social impairment in children and adults with high functioning autism spectrum disorders (ASD). Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Autism Spectrum Disorder, Pervasive Developmental Disorder, ASD
- What is being tested?
- Intranasal Oxytocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2017to 9 Jan 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females between 12 and 55 years of age.
- Meets the DSM-5 diagnostic criteria for Autism Spectrum Disorder (ASD) as established by clinical diagnostic interview
- At least moderate severity of ASD impairment as measured by a raw score of ≥85 on the SRS
- Participants and their parent/guardian must be able to speak and understand English sufficiently to comprehend the nature of the study and to allow for the completion of all study procedures required per protocol.
- Subjects and their parent/guardian must be considered reliable reporters. They must understand the nature of the study and must sign an IRB-approved informed consent form before initiation of any study procedures. Subjects and their parent/guardian must have a level of understanding sufficient to communicate with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
- Each subject and their parent/guardian must understand the nature of the study and provide written informed assent/consent.
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- Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.
- If the subject is sexually active, he/she must agree to use an acceptable form of birth control during the study. These include:
- Abstinence (no sexual contact)
- A barrier method (diaphragm plus spermicide or a condom plus spermicide) in addition to one of the following methods:
- Consistent use of an approved birth control pill
- Birth control patch
- Injected contraceptives
- Intrauterine device (IUD)
Who cannot join
- Impaired intellectual functioning and/or impaired spoken language.
- Clinically unstable psychiatric conditions or any serious medical illness, which will be assessed by study clinicians during the psychiatric interview and medical history review. If the clinical assessment suggests a psychiatric or medical condition demanding acute clinical attention, then the subject will be excluded from participating in the trial.
- Clinically unstable psychiatric conditions.
- Any serious medical illness
- Pregnant or nursing females.
- Known hypersensitivity to oxytocin.
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- Severe allergies or multiple adverse drug reactions.
- A non-responder or history of intolerance to oxytocin, after treatment at adequate doses as determined by the clinician.
- Subjects with significant nasal pathology (including atrophic rhinitis, recurrent nose bleeds, and history of hypophysectomy).
- Clinically abnormal baseline laboratory values falling significantly outside of the standard reference ranges for a basic metabolic screen.
- Investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- Currently enrolled or recently participated (within the past 6 months) in a clinical trial of intranasal oxytocin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Cambridge, Massachusetts, 02114
About this study
Official title: A Pilot Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder
This study is an 8-week pilot trial with oxytocin nasal spray (Syntocinon) as a treatment for social impairment in children and adults with high functioning autism spectrum disorders (ASD). The investigators hypothesize that oxytocin will be safe, tolerable, and effective in improving social deficits in individuals with ASD.
- Conditions
- Autism Spectrum Disorder, Pervasive Developmental Disorder, ASD, PDD
- Being tested
- Intranasal Oxytocin
- Keywords
- Autism Spectrum Disorders, Pervasive Developmental Disorder, ASD, PDD, Oxytocin, Syntocinon, Social Impairment, Treatment
- Medical subject headings
- Autism Spectrum Disorder, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal OxytocinDrug
Also called Syntocinon
This study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD).
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin- Participants ages 12-17 | Experimental | Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks. Receives: Drug: Intranasal Oxytocin |
| Oxytocin- Participants ages 18-55 | Experimental | Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks. Receives: Drug: Intranasal Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale From Baseline to Week 8
Change in ASD symptoms as measured by change from baseline on the Social Responsiveness Scale 2 (SRS-2) scale.
The SRS-2 is a 65-item rating scale completed that is used to measure the severity of autism spectrum symptoms as they occur in natural settings. The SRS-2 School Age form is completed by a parent or guardian for patients ages 9-17 and the SRS-2 Adult Self-report is completed by patients ages 18-59. Total raw scores range from 0 to 195, with higher scores indicating increased symptom severity.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study start9 Oct 2017
- Primary completion9 Jan 2019
- Study completion9 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gagan Joshi, Massachusetts General Hospital
- Investigators
- Gagan Joshi, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985749
- Sponsor's protocol ID
- 2016P002148
- Status last verified
- Jun 2024
- First submitted
- 17 Nov 2016
- Last updated
- 1 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02985749
- Acronym / sponsor ID
- 2016P002148
- Conditions
- Autism Spectrum Disorder, Pervasive Developmental Disorder, ASD, PDD
- Keywords
- Autism Spectrum Disorders, Pervasive Developmental Disorder, ASD, PDD, Oxytocin, Syntocinon, Social Impairment, Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 9 Jan 2019 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Posted 16 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an 8-week pilot trial with oxytocin nasal spray (Syntocinon) as a treatment for social impairment in children and adults with high functioning autism spectrum disorders (ASD). The investigators hypothesize that oxytocin will be safe, tolerable, and effective in improving social deficits in individuals with ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin- Participants ages 12-17 | Experimental | Drug: Intranasal OxytocinIntranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks. |
| Oxytocin- Participants ages 18-55 | Experimental | Drug: Intranasal OxytocinIntranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks. |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Males and females between 12 and 55 years of age.
- Meets the DSM-5 diagnostic criteria for Autism Spectrum Disorder (ASD) as established by clinical diagnostic interview
- At least moderate severity of ASD impairment as measured by a raw score of ≥85 on the SRS
- Participants and their parent/guardian must be able to speak and understand English sufficiently to comprehend the nature of the study and to allow for the completion of all study procedures required per protocol.
- Subjects and their parent/guardian must be considered reliable reporters. They must understand the nature of the study and must sign an IRB-approved informed consent form before initiation of any study procedures. Subjects and their parent/guardian must have a level of understanding sufficient to communicate with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
Key exclusion criteria (12 listed)
- Impaired intellectual functioning and/or impaired spoken language.
- Clinically unstable psychiatric conditions or any serious medical illness, which will be assessed by study clinicians during the psychiatric interview and medical history review. If the clinical assessment suggests a psychiatric or medical condition demanding acute clinical attention, then the subject will be excluded from participating in the trial.
- Clinically unstable psychiatric conditions.
- Any serious medical illness
- Pregnant or nursing females.
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 |
|---|---|---|
| Intranasal OxytocinAlso: SyntocinonThis study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD). | Drug | Oxytocin- Participants ages 12-17, Oxytocin- Participants ages 18-55 |
Primary outcome
Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale From Baseline to Week 8
Time frame: 8 weeks
Change in ASD symptoms as measured by change from baseline on the Social Responsiveness Scale 2 (SRS-2) scale. The SRS-2 is a 65-item rating scale completed that is used to measure the severity of autism spectrum symptoms as they occur in natural settings. The SRS-2 School Age form is completed by a parent or guardian for patients ages 9-17 and the SRS-2 Adult Self-report is completed by patients ages 18-59. Total raw scores range from 0 to 195, with higher scores indicating increased symptom severity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gagan Joshi, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intranasal Oxytocin in people with Autism Spectrum Disorder and Pervasive Developmental Disorder, run by Massachusetts General Hospital at 1 site 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 14 inclusion and 12 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 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale From Baseline to Week 8 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2024.