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

Condition	Intervention	Phase
Autism	Drug: Oxytocin	Phase I

Further study details as provided by Mount Sinai School of Medicine:

Expected Total Enrollment:  30

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.

Ages Eligible for Study:  18 Years   -   50 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. Meet DSM-IV, ADI, or ADOS criteria for autism spectrum disorder.
2. Age 18-65.
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

Please refer to this study by ClinicalTrials.gov identifier  NCT00263796

Kate Stamper, BA      212-241-7098    katherine.stamper@mssm.edu
Evdokia Anagnostou, MD      212-241-4229    evdokia.Anagnostou@mssm.edu

New York
      Mount Sinai School of Medicine, New York,  New York,  10029-6574,  United States

Study chairs or principal investigators

Eric Hollander, MD,  Principal Investigator,  Mount Sinai School of Medicine   

Study ID Numbers:  GCO # 04-0749 (2)
Last Updated:  December 8, 2005
Record first received:  December 7, 2005
ClinicalTrials.gov Identifier:  NCT00263796
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10