Back to resultsIntranasal Oxytocin and Learning in Autism
Primary Purpose
Autism Spectrum Disorders
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Syntocinon (synthetic oxytocin)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring Autism, Oxytocin, Syntocinon
Eligibility Criteria
Inclusion Criteria:
- Subjects aged 12-17 years, Mental age ≥ 7 (as measured by an IQ test such as the Differential Ability Scales II).
- Gender: males
- Diagnosis of an ASD
- Consent: parent/guardian permission and child assent.
- Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in English
- Study participant needs to be on 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 acquired neurological abnormality affecting brain function and motor, sensory or higher cognitive functioning.
- Patients with one or more of the following: HIV, HBV, 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., 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/P.I. (Suma Jacob, M.D,) that the patient is not suitable for the study due to unforeseeable safety issues.
Sites / Locations
- Center for Neurobehavioral Development
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo Group
Experimental Group
Arm Description
Placebo Comparator: Intranasal Placebo 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).
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.
Outcomes
Primary Outcome Measures
Change from Baseline to Post-testing on the The Part/Whole Identity Test
4) Part/Whole Identity Test measures the extent to which the participant employed a featural or holistic face recognition strategy. In this task, a sample face is presented for 4 sec, followed by a test face composed of either two whole faces or two face parts. As expected in Part/Whole Identity, effect sizes ranged from a low 0.30 for the part mouth condition to a high of 0.81 for the whole eye condition, such that the condition measuring holistic processing in the eye region was most sensitive to group differences. This measure was also most sensitive to behavioral changes with the LFI intervention trial.
Change from Baseline to Post-testing on the Reading the Mind in the Eyes Task
Reading the Mind in the Eyes Test (child version) (Baron-Cohen, et al., 2001) 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
Change from Baseline to Post-testing on measures of social attention, reward/motivation, perception and cognition
Behavioral tasks: watching social interactions eye tracking-task, happy faces eye-tracking tasks, signal detection social task, discrimination task
Full Information
NCT ID
NCT02090829
First Posted
February 28, 2014
Last Updated
October 30, 2019
Sponsor
University of Minnesota
Collaborators
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT02090829
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
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Low recruitment
Study Start Date
March 2014 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Children's Hospital of Philadelphia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
: The objective of this study is to determine the tolerability and therapeutic potential of oxytocin in children and adolescents with Autism Spectrum Disorders (ASD) when paired with a computer game intervention that is designed to enhance face perception skills. We designate two measures as our primary outcomes, based on prior published work with these interventions, and we propose a sample based on power analyses from these prior results. A second objective of this study is to learn about the breadth of possible positive effects that this combination therapy might have for children with ASD. To this end, we include a host of other exploratory measures that assess aspects of social motivation and attention, social perception, and social cognition. Thus, a second objective is to conduct a "signal finding" study - to gather outcome data on a range of dependent variables that theoretically should be related to oxytocin's effects on social processes, but for which there are no prior data. The signal finding aspect of this study will provide the preliminary data needed to design a more targeted follow up study.
Detailed Description
This is a double-blind placebo-controlled trial of intranasal oxytocin in 52 children and adolescents with ASD. Diagnosis will be confirmed using Diagnostic and Statistical Manual (DSM) criteria, supported by the Autism Diagnostic Interview and the Autism Diagnostic Observation Schedule. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of the FaceStation computer games, developed at CHOP. Measures of social function and cognition will be administered before and after the game play period. Two measures of social functioning will serve as our primary endpoints; all other measures will be treated as exploratory variables, with significance testing corrected for multiple comparisons.
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, Oxytocin, Syntocinon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator: Intranasal Placebo 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).
Arm Title
Experimental Group
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.
Intervention Type
Drug
Intervention Name(s)
Syntocinon (synthetic oxytocin)
Other Intervention Name(s)
Syntocinon
Intervention Description
Syntocinon is a nine residue cyclic peptide; the hormone is prepared synthetically to avoid possible contamination with vasopressin and other small polypeptides with biologic activity.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo Comparator: Intranasal Placebo 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).
Primary Outcome Measure Information:
Title
Change from Baseline to Post-testing on the The Part/Whole Identity Test
Description
4) Part/Whole Identity Test measures the extent to which the participant employed a featural or holistic face recognition strategy. In this task, a sample face is presented for 4 sec, followed by a test face composed of either two whole faces or two face parts. As expected in Part/Whole Identity, effect sizes ranged from a low 0.30 for the part mouth condition to a high of 0.81 for the whole eye condition, such that the condition measuring holistic processing in the eye region was most sensitive to group differences. This measure was also most sensitive to behavioral changes with the LFI intervention trial.
Time Frame
Baseline/Follow-up post testing (max 12 days)
Title
Change from Baseline to Post-testing on the Reading the Mind in the Eyes Task
Description
Reading the Mind in the Eyes Test (child version) (Baron-Cohen, et al., 2001) 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 to Post-testing (max. 12 days)
Secondary Outcome Measure Information:
Title
Change from Baseline to Post-testing on measures of social attention, reward/motivation, perception and cognition
Description
Behavioral tasks: watching social interactions eye tracking-task, happy faces eye-tracking tasks, signal detection social task, discrimination task
Time Frame
Baseline/follow-up (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:
Subjects aged 12-17 years, Mental age ≥ 7 (as measured by an IQ test such as the Differential Ability Scales II).
Gender: males
Diagnosis of an ASD
Consent: parent/guardian permission and child assent.
Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in English
Study participant needs to be on 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 acquired neurological abnormality affecting brain function and motor, sensory or higher cognitive functioning.
Patients with one or more of the following: HIV, HBV, 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., 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/P.I. (Suma Jacob, M.D,) that the patient is not suitable for the study due to unforeseeable safety issues.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suma Jacob, M.D. Ph.D
Organizational Affiliation
University of Minnesota Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Neurobehavioral Development
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
12. IPD Sharing Statement
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Intranasal Oxytocin and Learning in Autism
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