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Phase 2 N=30 Randomized Double-blind Basic Science

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

Autism · ASD

Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Empathic Accuracy Performance

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Syntocinon (Drug); Placebo (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Alexander Kolevzon
Primary completion
Apr 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Empathic Accuracy Performance
PRIMARY
Fmri BOLD Response During Empathic Accuracy Task

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01183221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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