Autistic DisorderPhase 1OxytocinASDNCT03183674
Oxytocin in Spectrum Autism Disorders
A Phase 1 study testing Oxytocin in people with Autistic Disorder, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Observe effects of oxytocin on individuals with autism spectrum disorder Read more about this study
- Who is it for?
- Ages 3 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jul 2016to 15 May 2018
- Phase
- Phase 1
- 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 3 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- CARS> 30
- age between 3 and 16 years
- stable (3 months with medication maintained or without medication)
Who cannot join
- participation in another research project of pharmacological or behavioral intervention in progress
- Use of pituitary hormones, cortisol, androgens and estrogens.
- heart problems: recent AMI, heart failure.
- respiratory problems: pneumonia, respiratory failure, decompensated asthma, acute bronchitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxytocin in Individuals With Spectrum Autism Disorders
Observe effects of oxytocin on individuals with autism spectrum disorder
Read the detailed description
To observe the effects of oxytocin on individuals with autism spectrum disorder according to gender, in facial recognition and eye tracking tests. The investigators will apply the nepsy and eye tracking tests before and 45 minutes after the puff with oxytocin or placebo at the dose of 0.4 IU / kg / dose maximum of 24 IU. The next week the volunteer will return and will do the same procedure because whoever took the placebo would take oxytocin and vice versa. Is a randomized, double-blind, placebo-controlled clinical trial.
- Conditions
- Autistic Disorder
- Being tested
- Oxytocin, placebo
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called syntocinon
Single dose oxytocin 45 minutes before the test
placeboOther
saline solution 0,9% spray nasal
| Study group | Role | What they receive |
|---|---|---|
| oxytocin spray | Experimental | oxytocin nose spray dose 0,4IU/kg, once unique dose Receives: Drug: Oxytocin |
| placebo | Placebo comparator | saline nose spray, 0,9 %, once unique dose Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye tracking
Eye tracking program
Measured: on average of 1 year
Secondary outcomes (1)
Nepsy
face recognize
Measured: on average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start15 Jul 2016
- Primary completion20 Jul 2017
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Paula Brentani, University of Sao Paulo General Hospital
- Investigators
- Debora Zambori, Study chair, Instituto de Psiquiatria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183674
- Sponsor's protocol ID
- 10922213.7.0000.0068-2
- Acronym
- OxytocinASD
- Status last verified
- Oct 2019
- First submitted
- 23 May 2017
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators intend to share research information, such as, harms and benefits
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin in Individuals With Spectrum Autism Disorders
- ClinicalTrials.gov ID
- NCT03183674
- Acronym / sponsor ID
- OxytocinASD / 10922213.7.0000.0068-2
- Conditions
- Autistic Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 12 Jun 2017 (actual)
- 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.
Observe effects of oxytocin on individuals with autism spectrum disorder
Detailed description
To observe the effects of oxytocin on individuals with autism spectrum disorder according to gender, in facial recognition and eye tracking tests. The investigators will apply the nepsy and eye tracking tests before and 45 minutes after the puff with oxytocin or placebo at the dose of 0.4 IU / kg / dose maximum of 24 IU. The next week the volunteer will return and will do the same procedure because whoever took the placebo would take oxytocin and vice versa. Is a randomized, double-blind, placebo-controlled clinical trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin spray | Experimental | Drug: Oxytocinoxytocin nose spray dose 0,4IU/kg, once unique dose |
| placebo | Placebo comparator | Other: placebosaline nose spray, 0,9 %, once unique dose |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- CARS> 30
- age between 3 and 16 years
- stable (3 months with medication maintained or without medication)
Key exclusion criteria (4 listed)
- participation in another research project of pharmacological or behavioral intervention in progress
- Use of pituitary hormones, cortisol, androgens and estrogens.
- heart problems: recent AMI, heart failure.
- respiratory problems: pneumonia, respiratory failure, decompensated asthma, acute bronchitis.
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 |
|---|---|---|
| OxytocinAlso: syntocinonSingle dose oxytocin 45 minutes before the test | Drug | oxytocin spray |
| placebosaline solution 0,9% spray nasal | Other | placebo |
Primary outcome
Eye tracking
Time frame: on average of 1 year
Eye tracking program
1 secondary outcome
Nepsy
Time frame: on average of 1 year
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 28 Oct 2019.
- Individual participant dataSharing planned: Yes. The investigators intend to share research information, such as, harms and benefits
Related trials for Autistic Disorder
Recruiting
Word Learning From Parentese in Autistic Children
Autism, Autism Spectrum Disorder
Recruiting
COMPASS Across Settings (CAST) for Improving Transition Outcomes for Students With ASD
Autism, Autism Spectrum Disorder
Recruiting
Impact of an E-Learning Coaching for Parents of Young Children With Autism
Autism Spectrum Disorder
Not yet recruiting
Evaluation of a Novel Quantum-Inspired Intervention (QII) for Children With Autism Spectrum Disorder: A Global Confirmatory Study
Autism Spectrum Disorder, Autism Spectrum Disorder (ASD
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
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.
Debora Zambori study chair
Instituto de Psiquiatria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxytocin in people with Autistic Disorder, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 3 inclusion and 4 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 28 Oct 2019. 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 Brazil. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Eye tracking (time frame: on average of 1 year). 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 28 Oct 2019.