Back to resultsIntranasal Oxytocin and Learning in Autism
Primary Purpose
Autism Spectrum Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intranasal Oxytocin (Trade name: Syntocinon)
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring Autism Spectrum Disorders, Oxytocin, Clinical Trial, Computer-based Intervention, Social Perception, Social Motivation, Social Cognition
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- The Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intranasal Oxytocin
Intranasal Placebo
Arm Description
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 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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01417026
Brief Title
Intranasal Oxytocin and Learning in Autism
Official Title
Promoting Social Perceptual Learning With Oxytocin in Autism
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Robert Schultz
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders
Keywords
Autism Spectrum Disorders, Oxytocin, Clinical Trial, Computer-based Intervention, Social Perception, Social Motivation, Social Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intranasal Oxytocin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intranasal Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intranasal Oxytocin (Trade name: Syntocinon)
Other Intervention Name(s)
Syntocinon
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery)
Description
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.
Time Frame
Baseline and Post-testing (after max. 12 days)
Title
Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version)
Description
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.
Time Frame
Baseline and Post-testing (after max. 12 days)
Secondary Outcome Measure Information:
Title
Changes From Baseline to Post-testing (After Max. 12 Days) on the "Happy Faces" Measure of Social Attention
Description
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.
Time Frame
Baseline and Post-testing (after max. 12 days)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert T. Schultz, PhD
Organizational Affiliation
Center for Autism Research, The Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Intranasal Oxytocin and Learning in Autism
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