AutismPhase 2NCT01183221
The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
A Phase 2 study testing Syntocinon in people with Autism and ASD, run by Alexander Kolevzon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- What is being tested?
- Syntocinon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2010to 25 Apr 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine - Seaver Autism Center for Research and Treatment
New York, New York, 10029
About this study
This study examines the effects of a single dose of intranasal oxytocin (vs. placebo) on complex social cognition in adults with autism spectrum disorders.
Read the 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.
- Being tested
- Syntocinon, Placebo
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyntocinonDrug
Also called Intranasal oxytocin
One dose of 24 IU (3 sprays/nostril)
PlaceboDrug
Intranasal Placebo
| Study group | Role | What they receive |
|---|---|---|
| Syntocinon then Placebo | Experimental | 24IU intranasal oxytocin, minimum of 3 weeks off, then placebo Receives: Drug: Syntocinon; Drug: Placebo |
| Placebo then Syntocinon | Placebo comparator | Placebo, minimum of 3 weeks off, then 24IU intranasal oxytocin or placebo Receives: Drug: Syntocinon; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 45 minutes after oxytocin/placebo administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study start18 Jun 2010
- Primary completion25 Apr 2014
- Study completion25 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexander Kolevzon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexander Kolevzon, Icahn School of Medicine at Mount Sinai
- Investigators
- Jennifer Bartz, P.h.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183221
- Sponsor's protocol ID
- GCO 09-0857
- Status last verified
- Mar 2021
- First submitted
- 12 Aug 2010
- Last updated
- 15 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT01183221
- Acronym / sponsor ID
- GCO 09-0857
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alexander KolevzonUniversity, hospital or other
- Study start
- 18 Jun 2010 (actual)
- Primary completion
- 25 Apr 2014 (actual)
- Study completion
- 25 Apr 2014 (actual)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Posted 15 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Syntocinon then Placebo | Experimental | Drug: Syntocinon, Drug: Placebo24IU intranasal oxytocin, minimum of 3 weeks off, then placebo |
| Placebo then Syntocinon | Placebo comparator | Drug: Syntocinon, Drug: PlaceboPlacebo, minimum of 3 weeks off, then 24IU intranasal oxytocin or placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SyntocinonAlso: Intranasal oxytocinOne dose of 24 IU (3 sprays/nostril) | Drug | Placebo then Syntocinon, Syntocinon then Placebo |
| PlaceboIntranasal Placebo | Drug | Placebo then Syntocinon, Syntocinon then Placebo |
Primary outcome
Empathic Accuracy Performance
Time frame: 45 minutes after drug/placebo administration
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
Time frame: 45 minutes after oxytocin/placebo administration
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Bartz, P.h.D. principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Syntocinon in people with Autism and ASD, run by Alexander Kolevzon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Empathic Accuracy Performance (time frame: 45 minutes after drug/placebo administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.