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This study examines the effects of a single dose of intranasal oxytocin (vs. placebo) on complex social cognition in adults with autism spectrum disorders.
Participants receive a one-time administration of 24-IU intranasal oxytocin (or placebo) and perform an empathic accuracy task, a novel and ecologically valid measure of complex social cognition, in conjunction with functional magnetic resonance imaging (fMRI). The investigators will investigate the effects of oxytocin (versus placebo) on the behavioral and neural correlates of empathic accuracy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Syntocinon then Placebo | Experimental | 24IU intranasal oxytocin, minimum of 3 weeks off, then placebo |
|
| Placebo then Syntocinon | Placebo Comparator | Placebo, minimum of 3 weeks off, then 24IU intranasal oxytocin or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Syntocinon | Drug | One dose of 24 IU (3 sprays/nostril) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Empathic Accuracy Performance | Participants watch videos of targets describing positive and negative autobiographical events and provide continuous ratings of how positive-negative the target is feeling on a 9-point Likert scale. Empathic accuracy is operationalized as a timecourse correlation between perceiver inferences about target affect and targets' own affect ratings. | 45 minutes after drug/placebo administration |
| Fmri BOLD Response During Empathic Accuracy Task | Images will be acquired using a 3.0 Tesla Siemens Allegra MRI scanner equipped to acquire gradient-echo, echoplanar T2*-weighted images (EPI) with blood oxygenation level dependent (BOLD) contrast. Each volume will comprise 26 axial slices of 4.5mm thickness and a 3.5 x 3.5mm in-plane resolution, aligned along the AC-PC axis. Volumes will be acquired continuously every 2 seconds. Each run will begin with 5 'dummy' volumes, which will be discarded from further analyses. At the end of the scanning session, a T-1 weighted structural image will be acquired from each participant. | 45 minutes after oxytocin/placebo administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Bartz, P.h.D. | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai School of Medicine - Seaver Autism Center for Research and Treatment | New York | New York | 10029 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Syntocinon Then Placebo | One dose 24IU (3 sprays/nostril) intranasal oxytocin, minimum of 3 weeks off, then Intranasal placebo |
| FG001 | Placebo Then Syntocinon | Intranasal Placebo, minimum of 3 weeks off, then 24IU (3 sprays/nostril) intranasal Syntocinon |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Dose |
| |||||||||||||
| 3 Weeks Wash Out |
| |||||||||||||
| Second Dose |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Syntocinon Then Placebo | One dose 24IU (3 sprays/nostril) intranasal oxytocin, minimum of 3 weeks off, then Intranasal placebo |
| BG001 | Placebo Then Syntocinon | Intranasal Placebo, minimum of 3 weeks off, then 24IU (3 sprays/nostril) intranasal Syntocinon |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Empathic Accuracy Performance | Participants watch videos of targets describing positive and negative autobiographical events and provide continuous ratings of how positive-negative the target is feeling on a 9-point Likert scale. Empathic accuracy is operationalized as a timecourse correlation between perceiver inferences about target affect and targets' own affect ratings. | The computer in the imaging suite crashed and the behavioral outcome data were not adequately backed up. The imaging data cannot be analyzed while pts were performing the EA task because without the behavioral data, the researchers do not know what pts were doing at each timepoint (it was an event related design). The researchers would not have the necessary information to know how to segment the data or what trial type (self/other/control) pts were doing at the various time points. | Posted | 45 minutes after drug/placebo administration |
|
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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 | Syntocinon | One dose 24IU (3 sprays/nostril) intranasal oxytocin, | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ringing Ears | Ear and labyrinth disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexander Kolevzon | Icahn School of Medicine at Mount Sinai | (212) 659-8762 | alexander.kolevzon@mssm.edu |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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Participants are randomized to receive 24IU intranasal oxytocin or placebo on days separated by a minimum of 3 weeks. Randomization order to drug condition is counter-balanced.
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Both the participant and investigator are blind to drug condition.
| Placebo | Drug | Intranasal Placebo |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
One dose 24IU (3 sprays/nostril) intranasal oxytocin, minimum of 3 weeks off, then Intranasal placebo
| OG001 | Placebo Then Syntocinon | Intranasal Placebo, minimum of 3 weeks off, then 24IU (3 sprays/nostril) intranasal Syntocinon |
|
| Primary | Fmri BOLD Response During Empathic Accuracy Task | Images will be acquired using a 3.0 Tesla Siemens Allegra MRI scanner equipped to acquire gradient-echo, echoplanar T2*-weighted images (EPI) with blood oxygenation level dependent (BOLD) contrast. Each volume will comprise 26 axial slices of 4.5mm thickness and a 3.5 x 3.5mm in-plane resolution, aligned along the AC-PC axis. Volumes will be acquired continuously every 2 seconds. Each run will begin with 5 'dummy' volumes, which will be discarded from further analyses. At the end of the scanning session, a T-1 weighted structural image will be acquired from each participant. | The computer in the imaging suite crashed and the behavioral outcome data were not adequately backed up. The imaging data cannot be analyzed while pts were performing the EA task because without the behavioral data, the researchers do not know what pts were doing at each timepoint (it was an event related design). The researchers would not have the necessary information to know how to segment the data or what trial type (self/other/control) pts were doing at the various time points. | Posted | 45 minutes after oxytocin/placebo administration |
|
|
| 28 |
| 0 |
| 28 |
| 8 |
| 28 |
| EG001 | Placebo | Intranasal Placebo | 0 | 28 | 0 | 28 | 10 | 28 |
| Headache | General disorders |
|
| Fatigue | General disorders |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders |
|
| Watery eyes | Endocrine disorders |
|
| Sore throat | Skin and subcutaneous tissue disorders |
|
| Cold hand | Skin and subcutaneous tissue disorders |
|
| Dizzy | General disorders | when got up from fMRI scan table |
|
| Burning in throat after nasal spray | Respiratory, thoracic and mediastinal disorders |
|
| Sinuses tender | Blood and lymphatic system disorders |
|
| Lack of focus | Psychiatric disorders |
|
| Felt body/joint pain | Musculoskeletal and connective tissue disorders |
|
| Breasts tender | Reproductive system and breast disorders |
|
| Difficulty sleeping | Psychiatric disorders |
|
| Light headedness | General disorders |
|
| Slowed thought process | Psychiatric disorders |
|
| Runny nose | Respiratory, thoracic and mediastinal disorders |
|
| Difficulty hearing | Ear and labyrinth disorders |
|
| Chest tightness | Cardiac disorders | vital signs stable |
|
| Mild diarrhea | Gastrointestinal disorders |
|
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |