Autism Spectrum DisorderPhase 2/3OXYASDNCT02007447
Oxytocin in Adolescents With Autism Spectrum Disorders
A Phase 2/3 study testing OCYTOCINA - SPRAY NASAL in people with Autism Spectrum Disorder, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This study is design to evaluate the influence of oxytocin in some aspects of Autism Spectrum Disorder (ASD), such as, repetitive and stereotyped behavior, social skills, quality of life and disruptive behaviors. Read more about this study
- Who is it for?
- Ages 12 to 18 years, men only
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- OCYTOCINA - SPRAY NASAL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to 4 May 2018
- Phase
- Phase 2/3
- 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 12 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male
- Age between 11 years 11 months and 17 years 11 months
- Autism spectrum disorder according to DSM V
- ADI > 10
- WISC > 70
- CARS > 30
Who cannot join
- Female
- presence of genetic and neurological syndromes
- changes in drugs or in any intervention during the study
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute os Psychiatry, Clinical Hospital at São Paulo
São Paulo, 05043-903
About this study
This study is design to evaluate the influence of oxytocin in some aspects of Autism Spectrum Disorder (ASD), such as, repetitive and stereotyped behavior, social skills, quality of life and disruptive behaviors.
Null hypothesis: social skills, quality of life, disruptive behaviors and repetitive behaviors do not improve with the use of oxytocin. Experimental Hypothesis: social skills, quality of life, disruptive behaviors and repetitive and stereotyped behaviors improve with the use of oxytocin.
Read the detailed description
Individuals with ASD have impaired social interaction, repetitive and disruptive behaviors. Oxytocin has been described to improve those skills and studies suggest that administration can reduce repetitive behaviors as well as enhance social interaction and communication deficits.
This study is design to evaluate the influence of oxytocin in some aspects of Autism Spectrum Disorder (ASD), such as, repetitive and stereotyped behavior, social skills, quality of life and disruptive behaviors.
Instruments:
- Evaluation of social skills: Matson Evaluation of Social Skills (MESSY): consisting of 62 items divided into six factors that assess social skills such as appropriate social skills, assertiveness inadequate, impulsivity, self-confidence, jealousy withdraw, and other items that do not fit another classification.
- Evaluation of repetitive behavior: Repetitive Behavior Scale (RBS): Consists of 43 items divided into six subscales: stereotyped behavior, self-harm behavior, compulsive behavior, ritualistic behavior, behavior monotonous and restricted behavior. This scale is able to measure the presence and severity of repetitive behaviors as common in individuals on the autism spectrum.
- Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior
- Multidimensional Student's Life Satisfaction Scale (MSLSS)
- Conditions
- Autism Spectrum Disorder
- Being tested
- OCYTOCINA - SPRAY NASAL
- Keywords
- autism, oxytocin, autism spectrum disorder, social skills.
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCYTOCINA - SPRAY NASALDrug
Also called SYNTOCINON - SPRAY NASAL, OXYTOCIN
The initial sample is divided into two groups (A and B): group A receive oxytocin intranasal for 8 weeks 24UI twice a day (3 applications per nostril 4UI 12/12 hours); group B will receive placebo for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| OCYTOCINA - SPRAY NASAL | Active comparator | OCYTOCINA - SPRAY NASAL - 24Ui twice per day for 8 weeks Receives: Drug: OCYTOCINA - SPRAY NASAL |
| Placebo | Placebo comparator | Placebo - twice per day for 8 weeks Receives: Drug: OCYTOCINA - SPRAY NASAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOCIAL SKILLS
Evaluation of social skills: Matson Evaluation of Social Skills (MESSY): consisting of 62 items divided into six factors that assess social skills such as appropriate social skills, assertiveness inadequate, impulsivity, self-confidence, jealousy withdraw, and other items that do not fit another classification.
Measured: 8 weeks
Secondary outcomes (1)
REPETITIVE BEHAVIOR
Evaluation of repetitive behavior: Repetitive Behavior Scale (RBS): Consists of 43 items divided into six subscales: stereotyped behavior, self-harm behavior, compulsive behavior, ritualistic behavior, behavior monotonous and restricted behavior. This scale is able to measure the presence and severity of repetitive behaviors as common in individuals on the autism spectrum.
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 posted10 Dec 2013 (estimated)
- Study startJun 2015
- Primary completionAug 2015
- Study completion4 May 2018
Why it stopped: Most of our patients had no willingness to participate in the survey
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 DisorderStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 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
- Helena P. Brentani, PHD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007447
- Sponsor's protocol ID
- CAAE 10922213.7.0000.0068
- Acronym
- OXYASD
- Status last verified
- Oct 2019
- First submitted
- 5 Dec 2013
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tachibana M, Kagitani-Shimono K, Mohri I, Yamamoto T, Sanefuji W, Nakamura A, Oishi M, Kimura T, Onaka T, Ozono K, Taniike M. Long-term administration of intranasal oxytocin is a safe and promising therapy for early adolescent boys with autism spectrum disorders. J Child Adolesc Psychopharmacol. 2013 Mar;23(2):123-7. doi: 10.1089/cap.2012.0048. Epub 2013 Mar 12.
PubMed 23480321
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 Adolescents With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02007447
- Acronym / sponsor ID
- OXYASD / CAAE 10922213.7.0000.0068
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, oxytocin, autism spectrum disorder, social skills.
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Most of our patients had no willingness to participate in the survey
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 10 Dec 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 study is design to evaluate the influence of oxytocin in some aspects of Autism Spectrum Disorder (ASD), such as, repetitive and stereotyped behavior, social skills, quality of life and disruptive behaviors.
Null hypothesis: social skills, quality of life, disruptive behaviors and repetitive behaviors do not improve with the use of oxytocin. Experimental Hypothesis: social skills, quality of life, disruptive behaviors and repetitive and stereotyped behaviors improve with the use of oxytocin.
Detailed description
Individuals with ASD have impaired social interaction, repetitive and disruptive behaviors. Oxytocin has been described to improve those skills and studies suggest that administration can reduce repetitive behaviors as well as enhance social interaction and communication deficits.
This study is design to evaluate the influence of oxytocin in some aspects of Autism Spectrum Disorder (ASD), such as, repetitive and stereotyped behavior, social skills, quality of life and disruptive behaviors.
Instruments:
- Evaluation of social skills: Matson Evaluation of Social Skills (MESSY): consisting of 62 items divided into six factors that assess social skills such as appropriate social skills, assertiveness inadequate, impulsivity, self-confidence, jealousy withdraw, and other items that do not fit another classification.
- Evaluation of repetitive behavior: Repetitive Behavior Scale (RBS): Consists of 43 items divided into six subscales: stereotyped behavior, self-harm behavior, compulsive behavior, ritualistic behavior, behavior monotonous and restricted behavior. This scale is able to measure the presence and severity of repetitive behaviors as common in individuals on the autism spectrum.
- Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior
- Multidimensional Student's Life Satisfaction Scale (MSLSS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCYTOCINA - SPRAY NASAL | Active comparator | Drug: OCYTOCINA - SPRAY NASALOCYTOCINA - SPRAY NASAL - 24Ui twice per day for 8 weeks |
| Placebo | Placebo comparator | Drug: OCYTOCINA - SPRAY NASALPlacebo - twice per day for 8 weeks |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Male
- Age between 11 years 11 months and 17 years 11 months
- Autism spectrum disorder according to DSM V
- ADI > 10
- WISC > 70
Key exclusion criteria (3 listed)
- Female
- presence of genetic and neurological syndromes
- changes in drugs or in any intervention during the study
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 |
|---|---|---|
| OCYTOCINA - SPRAY NASALAlso: SYNTOCINON - SPRAY NASAL, OXYTOCINThe initial sample is divided into two groups (A and B): group A receive oxytocin intranasal for 8 weeks 24UI twice a day (3 applications per nostril 4UI 12/12 hours); group B will receive placebo for 8 weeks | Drug | OCYTOCINA - SPRAY NASAL, Placebo |
Primary outcome
SOCIAL SKILLS
Time frame: 8 weeks
Evaluation of social skills: Matson Evaluation of Social Skills (MESSY): consisting of 62 items divided into six factors that assess social skills such as appropriate social skills, assertiveness inadequate, impulsivity, self-confidence, jealousy withdraw, and other items that do not fit another classification.
1 secondary outcome
REPETITIVE BEHAVIOR
Time frame: 8 WEEKS
Results and safety
The study was stopped early (reason given: Most of our patients had no willingness to participate in the survey). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Background: PubMed 23480321Tachibana M, Kagitani-Shimono K, Mohri I, Yamamoto T, Sanefuji W, Nakamura A, Oishi M, Kimura T, Onaka T, Ozono K, Taniike M. Long-term administration of intranasal oxytocin is a safe and promising therapy for early adolescent boys with autism spectrum disorders. J Child Adolesc Psychopharmacol. 2013 Mar;23(2):123-7. doi: 10.1089/cap.2012.0048. Epub 2013 Mar 12.
- Individual participant dataSharing planned: No
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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.
Helena P. Brentani, PHD principal investigator
University of Sao Paulo 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 2/3 study testing OCYTOCINA - SPRAY NASAL in people with Autism Spectrum 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 6 inclusion and 3 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: stopped early, 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 combined 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.
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?
The study was stopped early (reason given: Most of our patients had no willingness to participate in the survey). Results are not available in the source record.
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?
SOCIAL SKILLS (time frame: 8 weeks). 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 NCT02007447, 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 28 Oct 2019.