Autism Spectrum DisordersPhase 2NCT01417026
Intranasal Oxytocin and Learning in Autism
A Phase 2 study testing Intranasal Oxytocin (Trade name: Syntocinon) in people with Autism Spectrum Disorders, run by Robert Schultz at 1 site in United States.
Trial summary
The main objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with autism spectrum disorder (ASD) when paired with a computer game intervention that is designed to enhance face perception skills. Read more about this study
- Who is it for?
- Ages 12 to 17 years, men only
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Intranasal Oxytocin (Trade name: Syntocinon)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Apr 2015
- Phase
- Phase 2
- 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 17 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Participants aged 12-17 years, Mental age ≥ 10
- Gender: males
- Diagnosis of an Autism Spectrum Disorder
- Consent: parent/guardian permission and child assent.
- Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in English (and English as a first language).
- Study participant needs to be clinically stable, in the opinion of the study clinicians. Stability will be assessed by the clinicians based on information from and conversations with the parent, if necessary. The parent needs to commit verbally to not making any changes to his or her child's current treatments for the duration of this study.
Who cannot join
- History of traumatic brain injury, epilepsy/seizure disorder (except febrile seizures), or other significant medical, genetic, or neurological abnormality affecting growth, development, or motor or higher cortical functioning. Sensory impairments (e.g., significant vision/hearing loss).
- Patients with one or more of the following: Human immunodeficiency virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), hemophilia (bleeding problems, recent nose and brain injuries), abnormal blood pressure (hypotension or hypertension), drug abuse, immunity disorder, or severe depression.
- Sensory impairments (e.g., significant vision/hearing loss).
- Gestational age below 35 weeks and/or perinatal injury.
- Profound mental retardation (e.g., Intelligence quotient (IQ) < 45) or sensory-motor difficulties that would preclude valid use of diagnostic instruments.
- Lack of impairment in face recognition as determined by average or above average performance on the Benton Face Recognition Task.
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- Female participants.
- Patients who are sensitive to Syntocinon or any components of its formulation.
- Fever at the time of the baseline visit, defined as temperature above 37.5 degrees Celsius or 99.5 degrees Fahrenheit.
- Judgment by the study physician or the PI that the patient is not suitable for the study due to unforeseeable safety issues.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Promoting Social Perceptual Learning With Oxytocin in Autism
The main objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with autism spectrum disorder (ASD) when paired with a computer game intervention that is designed to enhance face perception skills.
Read the detailed description
Recognizing faces is critical to social functioning, and can be improved for individuals with ASD by using intervention software in the form of appropriately designed computer games. The effects of this type of social intervention may be amplified with the concurrent use of oxytocin. Furthermore, these learning effects may impact social skills in general and translate to the level of the individual's everyday social behavior. Thus, the objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with ASD when paired with a computer game intervention that is designed to enhance face perception skills.
- Conditions
- Autism Spectrum Disorders
- Being tested
- Intranasal Oxytocin (Trade name: Syntocinon)
- Keywords
- Autism Spectrum Disorders, Oxytocin, Clinical Trial, Computer-based Intervention, Social Perception, Social Motivation, Social Cognition
- 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.
Intranasal Oxytocin (Trade name: Syntocinon)Drug
Also called Syntocinon
This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Oxytocin | Active comparator | * Intranasal oxytocin (Trade name: Syntocinon)
* Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.
* Route of administration: Intranasal
* Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.
* One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).
* Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland. Receives: Drug: Intranasal Oxytocin (Trade name: Syntocinon) |
| Intranasal Placebo | Placebo comparator | * Intranasal placebo
* The placebo is identical to the oxytocin formulation with the exception of the active compound.
* Route of administration: Intranasal
* Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.
* One dose equals 6 spray puffs (3 puffs in each nostril).
* Placebo will be imported from Victoria Pharmacy Zurich- Switzerland. Receives: Drug: Intranasal Oxytocin (Trade name: Syntocinon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery)
This test measures the extent to which the participant employed a featural or holistic face recognition strategy. A sample face is presented, followed by a test face composed of either two whole faces or two face parts.
Measured: Baseline and Post-testing (after max. 12 days)
Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version)
This is a test of emotion recognition. This test asks children to pick the best word out of four options to describe the mental state of a set of eyes. The test includes 28 photographs of eyes with both affective (e.g., upset) and cognitive (e.g., thoughtful) mental state words as choices.
Measured: Baseline and Post-testing (after max. 12 days)
Secondary outcomes (1)
Changes From Baseline to Post-testing (After Max. 12 Days) on the "Happy Faces" Measure of Social Attention
The "Happy Faces" task requires that participants look at a series of faces of men and women. Faces are presented on the screen one by one and children are asked just to look at the faces. Eye movements are measured with a Tobii x120 tabletop eye-tracker to evaluate participants' looking patterns towards the eyes versus the mouth region.
Measured: Baseline and Post-testing (after max. 12 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2015
- Study completionApr 2015
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 DisordersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Schultz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Schultz, Children's Hospital of Philadelphia
- Investigators
- Robert T. Schultz, PhD, Principal investigator, Center for Autism Research, The Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417026
- Sponsor's protocol ID
- 11-008241
- Status last verified
- Feb 2017
- First submitted
- 11 Aug 2011
- Last updated
- 30 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Social Perceptual Learning With Oxytocin in Autism
- ClinicalTrials.gov ID
- NCT01417026
- Acronym / sponsor ID
- 11-008241
- Conditions
- Autism Spectrum Disorders
- Keywords
- Autism Spectrum Disorders, Oxytocin, Clinical Trial, Computer-based Intervention, Social Perception, Social Motivation, Social Cognition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Robert SchultzUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Posted 30 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with autism spectrum disorder (ASD) when paired with a computer game intervention that is designed to enhance face perception skills.
Detailed description
Recognizing faces is critical to social functioning, and can be improved for individuals with ASD by using intervention software in the form of appropriately designed computer games. The effects of this type of social intervention may be amplified with the concurrent use of oxytocin. Furthermore, these learning effects may impact social skills in general and translate to the level of the individual's everyday social behavior. Thus, the objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with ASD when paired with a computer game intervention that is designed to enhance face perception skills.
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 |
|---|---|---|
| Intranasal Oxytocin | Active comparator | Drug: Intranasal Oxytocin (Trade name: Syntocinon)* Intranasal oxytocin (Trade name: Syntocinon) * Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary. * Route of administration: Intranasal * Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days. * One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril). * Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland. |
| Intranasal Placebo | Placebo comparator | Drug: Intranasal Oxytocin (Trade name: Syntocinon)* Intranasal placebo * The placebo is identical to the oxytocin formulation with the exception of the active compound. * Route of administration: Intranasal * Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days. * One dose equals 6 spray puffs (3 puffs in each nostril). * Placebo will be imported from Victoria Pharmacy Zurich- Switzerland. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Participants aged 12-17 years, Mental age ≥ 10
- Gender: males
- Diagnosis of an Autism Spectrum Disorder
- Consent: parent/guardian permission and child assent.
- Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in English (and English as a first language).
Key exclusion criteria (10 listed)
- History of traumatic brain injury, epilepsy/seizure disorder (except febrile seizures), or other significant medical, genetic, or neurological abnormality affecting growth, development, or motor or higher cortical functioning. Sensory impairments (e.g., significant vision/hearing loss).
- Patients with one or more of the following: Human immunodeficiency virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), hemophilia (bleeding problems, recent nose and brain injuries), abnormal blood pressure (hypotension or hypertension), drug abuse, immunity disorder, or severe depression.
- Sensory impairments (e.g., significant vision/hearing loss).
- Gestational age below 35 weeks and/or perinatal injury.
- Profound mental retardation (e.g., Intelligence quotient (IQ) < 45) or sensory-motor difficulties that would preclude valid use of diagnostic instruments.
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 Oxytocin (Trade name: Syntocinon)Also: SyntocinonThis is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period. | Drug | Intranasal Oxytocin, Intranasal Placebo |
Primary outcome
Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery)
Time frame: Baseline and Post-testing (after max. 12 days)
This test measures the extent to which the participant employed a featural or holistic face recognition strategy. A sample face is presented, followed by a test face composed of either two whole faces or two face parts.
Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version)
Time frame: Baseline and Post-testing (after max. 12 days)
This is a test of emotion recognition. This test asks children to pick the best word out of four options to describe the mental state of a set of eyes. The test includes 28 photographs of eyes with both affective (e.g., upset) and cognitive (e.g., thoughtful) mental state words as choices.
1 secondary outcome
Changes From Baseline to Post-testing (After Max. 12 Days) on the "Happy Faces" Measure of Social Attention
Time frame: Baseline and Post-testing (after max. 12 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- 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.
Robert T. Schultz, PhD principal investigator
Center for Autism Research, The Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intranasal Oxytocin (Trade name: Syntocinon) in people with Autism Spectrum Disorders, run by Robert Schultz 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 6 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 30 Mar 2017. 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. 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?
Yes. Results are posted in the registry (first posted 30 Mar 2017). 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 From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery) (time frame: Baseline and Post-testing (after max. 12 days)). 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?
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 30 Mar 2017.