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Autism spectrum disorder (ASD) is a group of severe, life-long developmental disorders. Oxytocin (OT) is a neurohormone involved in both repetitive/rigid and social behaviors. This study is focusing on how a single dose of intranasal OT (IN-OT) affects cognitive rigidity and social perception tasks. Taking OT as a spray through the nose increases social and decreases repetitive behavior in some adults with ASD, and we are exploring if it helps children with ASD similarly. However, it is unclear whether every person with ASD has an abnormal OT level, and if OT affects restrictive or social behavior differently. Consequently, we aim to study whether OT treatment can be effective in treating subgroups with specific features of ASD. We will use approaches utilizing both behavioral and physiological responses to clarify the role of OT in ASD. We will develop a deeper understanding of the range of social and rigid behaviors and use that information to identify persons with ASD who would benefit from OT treatment. Potential subjects will be asked if they want to participate in two sessions in our clinical laboratory where they will get either single dose IN-OT or placebo. After receiving the substance, they will be asked to do a handful of tasks while we monitor heart rate, eye movements, and collect baseline and post intranasal blood, urine and saliva. The levels of hormones, metabolites and peptides related to or interacting with OT will be measures in the collected samples of blood plasma, urine and saliva. Additionally DNA will be extracted from the blood samples to study genes related to OT and ASD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Saline Nasal spray designed to look and feel like the drug intervention |
|
| Intranasal Oxytocin | Experimental | Oxytocin nasal spray designed to look as seem exactly like Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Oxytocin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Reading the Mind in the Eyes Task (RMET) | Social Cognition Task-- We are reporting raw score (# of correct responses) Minimum value is 0 and maximum value is 28. A higher score means better performance / outcome. | 2 weeks |
| Rapid Automatized Naming (RAN) | Cognitive Rigidity Task for >10 years old-- Time to name attribute of stimulus requested; minimum time is 0, there is no maximum time. Lower score is better. | 2 weeks |
| Dynamic Affect Recognition Evaluation (DARE) | Task Performance with Physiological Data. We reported the raw score - total number correct. Minimum is 0, maximum is 12. Higher score means better performance / outcome. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suma Jacob, MD/PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Neurobehavioral Development | Minneapolis | Minnesota | 55414 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then Intranasal Oxytocin | Saline Nasal spray designed to look and feel like the drug intervention Placebo |
| FG001 | Intranasal Oxytocin Then Placebo | Oxytocin nasal spray designed to look as seem exactly like Placebo Intranasal Oxytocin |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants (cross-over design) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reading the Mind in the Eyes Task (RMET) | Social Cognition Task-- We are reporting raw score (# of correct responses) Minimum value is 0 and maximum value is 28. A higher score means better performance / outcome. | Posted | Mean | Standard Deviation | total raw score | 2 weeks |
|
6 weeks per participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Saline Nasal spray designed to look and feel like the drug intervention, then Placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suma Jacob, MD, PhD | University of Minnesota | 612-624-0018 | sjacob@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2015 | Mar 18, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 16, 2015 | Mar 18, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Rapid Automatized Naming (RAN) | Cognitive Rigidity Task for >10 years old-- Time to name attribute of stimulus requested; minimum time is 0, there is no maximum time. Lower score is better. | Posted | Mean | Standard Deviation | naming time (seconds) | 2 weeks |
|
|
|
| Primary | Dynamic Affect Recognition Evaluation (DARE) | Task Performance with Physiological Data. We reported the raw score - total number correct. Minimum is 0, maximum is 12. Higher score means better performance / outcome. | Posted | Mean | Standard Deviation | total raw score | 2 weeks |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 14 |
| 27 |
| EG001 | Intranasal Oxytocin | Oxytocin nasal spray designed to look as seem exactly like Placebo, then Intranasal Oxytocin | 0 | 27 | 0 | 27 | 13 | 27 |
| Bloody nose | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Mouth pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Greater awakeness | General disorders | Non-systematic Assessment |
|
| Energized | General disorders | Non-systematic Assessment |
|
| Lightheadedness | General disorders | Non-systematic Assessment |
|
| Greater calmness | Nervous system disorders | Non-systematic Assessment |
|
| Less anxiety | Nervous system disorders | Non-systematic Assessment |
|
| Perseveration | Nervous system disorders | Non-systematic Assessment |
|
| Less flexibility | General disorders | Non-systematic Assessment |
|
| Loss of appetite | General disorders | Non-systematic Assessment |
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| Agitation | Nervous system disorders | Non-systematic Assessment |
|
| Drowsiness | Nervous system disorders | Non-systematic Assessment |
|
| Dry mouth | General disorders | Non-systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Chill | General disorders | Non-systematic Assessment |
|
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| Non-symbolic: Intervention Period 1 |
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| Non-symbolic: Intervention Period 2 |
|