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Trial · Interventional

CompletedPhase 2Results postedRegistry data

The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders

Overview

Status
Completed
Phase
Phase 2
Enrollment
30 participants (actual)
Sponsor
Alexander Kolevzon · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
18 Jun 2010
Primary completion
25 Apr 2014
Completion
25 Apr 2014
First posted
17 Aug 2010 (estimated)
Last update posted
15 Apr 2021
Conditions
Autism · ASD

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020112012201320142015
  1. Ph 2

    The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders

    NCT01183221

    18 Jun 2010 to 25 Apr 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study examines the effects of a single dose of intranasal oxytocin (vs. placebo) on complex social cognition in adults with autism spectrum disorders.

Interventions

  • SyntocinonDrug
  • PlaceboDrug

Arms2

  • Experimental

    Syntocinon then Placebo

    24IU intranasal oxytocin, minimum of 3 weeks off, then placebo

  • Placebo comparator

    Placebo then Syntocinon

    Placebo, minimum of 3 weeks off, then 24IU intranasal oxytocin or placebo

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Empathic Accuracy Performance

    Time frame · 45 minutes after drug/placebo administration

    Registry 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.

  2. Fmri BOLD Response During Empathic Accuracy Task

    Time frame · 45 minutes after oxytocin/placebo administration

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 45 minutes after drug/placebo administration

Empathic Accuracy Performance

GroupValue
Syntocinon Then Placebonot posted
Placebo Then Syntocinonnot posted
Primary outcome· 45 minutes after oxytocin/placebo administration

Fmri BOLD Response During Empathic Accuracy Task

GroupValue
Syntocinon Then Placebonot posted
Placebo Then Syntocinonnot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
SyntocinonOne dose 24IU (3 sprays/nostril) intranasal oxytocin,0 / 280 / 288 / 28
PlaceboIntranasal Placebo0 / 280 / 2810 / 28

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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