Back to resultsThe Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
Primary Purpose
Autism, ASD
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Syntocinon
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Autism
Eligibility Criteria
Inclusion Criteria:
- In good physical health
- Meet criteria for ASD according to psychiatric interview using the Diagnostic and Statistic Manual, Fourth Edition (DSM-IV)
- Must be a history of developmental delay
- Must meet full criteria for ASD on the Autism Diagnostic Interview- Revised (ADI-R) on either the social or communication domains and within two points on other domain (only if parent available for interview)
- Must meet full criteria for ASD on the Autism Diagnostic Observation Schedule- Generic (ADOS-G) on the social domain. Meeting for ASD on the communication domain and total domain is not necessary
- Must have a verbal IQ greater than 75, as measured by the Wechsler Adult Intelligence Scale- Fourth Edition (WAIS- III). Intelligence testing performed at other sites or through another protocol at this site within the past year will also be accepted
- Capability of performing experimental tasks (i.e. can read and understand task instructions, cooperate with procedures)
- Informed consent and capacity
- Female participants must remain on birth control for the duration of the study
Exclusion Criteria:
- Participants with any primary psychiatric diagnosis at screening
- Participants with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal MRI/structural lesion of the brain
- Participants who are pregnant, who gave birth in the last six months, or who are currently breastfeeding
- Participants with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being
- Participants with evidence or history of malignancy or any significant hematological endocrine, cardiovascular (including rhythm disorder), respiratory, renal, hepatic, gastrointestinal disease, or other major medical conditions
- Participants taking psychoactive medication(s) (e.g., stimulants, antidepressants, antipsychotics, antiepileptics, anxiolytics, clondine)
- Participants who, in the Investigator's opinion, might not be suitable for the study
- Participants who are involved in another study whose procedures could influence performance in the current study
- Female participants who do not stay on birth control for the duration of the study
- Participants who have a known contraindication to the MRI scan: including sever claustrophobia or any kind of metal implant in the body
Sites / Locations
- Mount Sinai School of Medicine - Seaver Autism Center for Research and Treatment
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Syntocinon then Placebo
Placebo then Syntocinon
Arm Description
24IU intranasal oxytocin, minimum of 3 weeks off, then placebo
Placebo, minimum of 3 weeks off, then 24IU intranasal oxytocin or placebo
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01183221
Brief Title
The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
Official Title
The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 18, 2010 (Actual)
Primary Completion Date
April 25, 2014 (Actual)
Study Completion Date
April 25, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alexander Kolevzon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study examines the effects of a single dose of intranasal oxytocin (vs. placebo) on complex social cognition in adults with autism spectrum disorders.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, ASD
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantInvestigator
Masking Description
Both the participant and investigator are blind to drug condition.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Syntocinon then Placebo
Arm Type
Experimental
Arm Description
24IU intranasal oxytocin, minimum of 3 weeks off, then placebo
Arm Title
Placebo then Syntocinon
Arm Type
Placebo Comparator
Arm Description
Placebo, minimum of 3 weeks off, then 24IU intranasal oxytocin or placebo
Intervention Type
Drug
Intervention Name(s)
Syntocinon
Other Intervention Name(s)
Intranasal oxytocin
Intervention Description
One dose of 24 IU (3 sprays/nostril)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intranasal Placebo
Primary Outcome Measure Information:
Title
Empathic Accuracy Performance
Description
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.
Time Frame
45 minutes after drug/placebo administration
Title
Fmri BOLD Response During Empathic Accuracy Task
Description
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.
Time Frame
45 minutes after oxytocin/placebo administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In good physical health
Meet criteria for ASD according to psychiatric interview using the Diagnostic and Statistic Manual, Fourth Edition (DSM-IV)
Must be a history of developmental delay
Must meet full criteria for ASD on the Autism Diagnostic Interview- Revised (ADI-R) on either the social or communication domains and within two points on other domain (only if parent available for interview)
Must meet full criteria for ASD on the Autism Diagnostic Observation Schedule- Generic (ADOS-G) on the social domain. Meeting for ASD on the communication domain and total domain is not necessary
Must have a verbal IQ greater than 75, as measured by the Wechsler Adult Intelligence Scale- Fourth Edition (WAIS- III). Intelligence testing performed at other sites or through another protocol at this site within the past year will also be accepted
Capability of performing experimental tasks (i.e. can read and understand task instructions, cooperate with procedures)
Informed consent and capacity
Female participants must remain on birth control for the duration of the study
Exclusion Criteria:
Participants with any primary psychiatric diagnosis at screening
Participants with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal MRI/structural lesion of the brain
Participants who are pregnant, who gave birth in the last six months, or who are currently breastfeeding
Participants with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being
Participants with evidence or history of malignancy or any significant hematological endocrine, cardiovascular (including rhythm disorder), respiratory, renal, hepatic, gastrointestinal disease, or other major medical conditions
Participants taking psychoactive medication(s) (e.g., stimulants, antidepressants, antipsychotics, antiepileptics, anxiolytics, clondine)
Participants who, in the Investigator's opinion, might not be suitable for the study
Participants who are involved in another study whose procedures could influence performance in the current study
Female participants who do not stay on birth control for the duration of the study
Participants who have a known contraindication to the MRI scan: including sever claustrophobia or any kind of metal implant in the body
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Bartz, P.h.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai School of Medicine - Seaver Autism Center for Research and Treatment
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
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