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

NCT ID: NCT00263796

Last Updated: 2014-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2012-09-30

Brief Summary

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

Detailed Description

Autism is a developmental disorder affecting approximately 60/10,000 individuals. It is characterized by social and language deficits and repetitive behaviors/restricted interests. Functional imaging is becoming a very useful tool in trying to understand the neurobiology of autism. Oxytocin is a hormone produced by the brain to assist with labor and lactation. Recent evidence suggests that it may be involved in social attachment and in repetitive behaviors. In this project, we will study how oxytocin changes the way the brain of autistic adults processes faces, and deals with response inhibition (the ability to interrupt ongoing responses should they prove ineffective or interfering with attaining a goal). There is currently no functional imaging data assessing the effect of oxytocin on the brain. We will explore the activation patterns in response to oxytocin across circuits involved in social cognition (face fusiform area) and response inhibition (caudate, orbitofrontal and dorsolateral cortex) by administering a specific fMRI task activating those circuits before and during an oxytocin infusion. We will also explore the effect of oxytocin in these areas by administering specific cognitive testing not associated with fMRI before and during oxytocin infusion.

Conditions

Autism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pitocin

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

10 international units = 1 cc, IV over 4 hours

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Normal Saline, IV over 4 hours

Interventions

Oxytocin

10 international units = 1 cc, IV over 4 hours

Intervention Type: DRUG

Placebo

Normal Saline, IV over 4 hours

Intervention Type: DRUG

Other Intervention Names

Pitocin

Eligibility Criteria

Inclusion Criteria

1. Meet DSM-IV, ADI, or ADOS criteria for autism spectrum disorder.

2. Age 18-50.

3. Be seen as outpatients

4. IQ>80

5. 5. Demonstrate capacity to provide authorized informed consent or provide consent for participation by an approved surrogate on the autistic individual's behalf

Exclusion Criteria

1. Subjects who are pregnant or nursing mothers. Sexually active women of childbearing potential who are not using adequate birth control measures.

2. Subjects with epilepsy.

3. Subjects with a history of schizophrenia, schizoaffective disorder or other Axis 1 mental disorders, such as bipolar disorder.

4. Subjects reporting history of encephalitis, phenylketonuria, tuberous sclerosis, fragile X syndrome, anoxia during birth, neurofibromatosis, hypomelanosis, hypothyroidism, Duchenne muscular dystrophy, and maternal rubella

5. Subjects who have received depot neuroleptic medication, or other psychoactive drugs within the past 5 weeks.

6. Subjects with renal or liver disease or abnormalities in blood chemistry.

7. 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

8. Claustrophobia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anagnostou, Evdokia, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Evdokia Anagnostou

Adjunct Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evdokia Anagnostou, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

GCO # 04-0749 (2)

Identifier Type: -

Identifier Source: org_study_id