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

NCT01183221 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: GCO 09-0857
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism; ASD

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Syntocinon then Placebo

EXPERIMENTAL

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

Drug: Syntocinon; Drug: Placebo

Placebo then Syntocinon

PLACEBO COMPARATOR

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

Drug: Syntocinon; Drug: Placebo

Interventions

Syntocinon DRUG

One dose of 24 IU (3 sprays/nostril)

Also known as: Intranasal oxytocin

Placebo then Syntocinon; Syntocinon then Placebo

Placebo DRUG

Intranasal Placebo

Placebo then Syntocinon; Syntocinon then Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexander Kolevzon: lead

Study Sites (1)

Mount Sinai School of Medicine - Seaver Autism Center for Research and Treatment

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Alexander Kolevzon
• Organization: Icahn School of Medicine at Mount Sinai

alexander.kolevzon@mssm.edu

(212) 659-8762

Study Officials

• Jennifer Bartz, P.h.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both the participant and investigator are blind to drug condition.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 17, 2010
• Study Start: June 18, 2010
• Primary Completion: April 25, 2014
• Study Completion: April 25, 2014
• Last Updated: April 15, 2021
• Results First Posted: April 15, 2021

Record last verified: 2021-03

Locations

US (1)