An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism

NCT00263796 | Completed Phase 1 DMC

• 1 other identifier: GCO # 04-0749 (2)
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To study the effect of oxytocin on face processing and response inhibition in autistic adults by fMRI.

Conditions

Autism

Outcome Measures

Primary Outcomes (1)

• Change in BOLD with oxytocin infusion

  Change in BOLD with oxytocin infusion BOLD - blood-oxygen-level-dependent contrast

  baseline and 4 hours

Study Arms (2)

Pitocin

EXPERIMENTAL

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Oxytocin DRUG

10 international units = 1 cc, IV over 4 hours

Also known as: Pitocin

Pitocin

Placebo DRUG

Normal Saline, IV over 4 hours

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meet DSM-IV, ADI, or ADOS criteria for autism spectrum disorder.
• Age 18-50.
• Be seen as outpatients
• IQ\>80
• \. Demonstrate capacity to provide authorized informed consent or provide consent for participation by an approved surrogate on the autistic individual's behalf

You may not qualify if:

• Subjects who are pregnant or nursing mothers. Sexually active women of childbearing potential who are not using adequate birth control measures.
• Subjects with epilepsy.
• Subjects with a history of schizophrenia, schizoaffective disorder or other Axis 1 mental disorders, such as bipolar disorder.
• Subjects reporting history of encephalitis, phenylketonuria, tuberous sclerosis, fragile X syndrome, anoxia during birth, neurofibromatosis, hypomelanosis, hypothyroidism, Duchenne muscular dystrophy, and maternal rubella
• Subjects who have received depot neuroleptic medication, or other psychoactive drugs within the past 5 weeks.
• Subjects with renal or liver disease or abnormalities in blood chemistry.
• Any metallic prosthesis such as plates, pins and screws, shrapnel, metallic foreign body, vascular or neurosurgical clips that may be incompatible with the MRI and any electrical devices such as a pacemaker or a defibrillator
• Claustrophobia

Sponsors & Collaborators

• Anagnostou, Evdokia, M.D.: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029-6574, 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

Study Officials

• Evdokia Anagnostou, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor

Study Record Dates

• First Submitted: December 7, 2005
• First Posted: December 9, 2005
• Study Start: March 1, 2006
• Primary Completion: October 1, 2010
• Study Completion: September 1, 2012
• Last Updated: April 30, 2014

Record last verified: 2014-04

Locations

US (1)