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Sponsored by: |
Mount Sinai School of Medicine |
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Information provided by: | Mount Sinai School of Medicine |
ClinicalTrials.gov Identifier: | NCT00490802 |
The purpose of this study is to learn whether or not the drug called Oxytocin is helpful in improving mood and social functioning in adults with autism.
Condition | Intervention | Phase |
---|---|---|
Autism |
Drug: Oxytocin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Intranasal Oxytocin in the Treatment of Autism |
Study Start Date: | June 2006 |
Definition: Extended description of the protocol, including information not already contained in other fields, such as comparison(s) studied.
Autism is a developmental disorder characterized by abnormalities in speech and communication, impaired social functioning, and repetitive behaviors and restricted interests (American Psychiatric Association, 2000). A number of researchers have suggested that the neuropeptide oxytocin may be implicated in the etiology of autism (Hollander et al., 2003; Insel et al., 1999; Lim et al., 2005; McCarthy & Altemus, 1997; Modahl et al., 1992; Waterhouse et al., 1996). Given the likely possibility of dysregulated oxytocin in autism, the goal of this pilot study is to investigate the long-term therapeutic effects of oxytocin in the treatment of autism. One practical issue with oxytocin is that it does not exist in a pill form. Only the intravenous form is available in the US and this form may or may not pass the blood-brain barrier. In addition, IV oxytocin is not practical for treatment studies. One alternative is intranasal oxytocin; this form of administration is known to pass the blood-brain barrier, and it is easy for participants to self-administer. Although not available in the US, we are in the process of receiving an IND exemption for its use and can import it from Europe. Thus, this pilot investigation will explore daily intranasal oxytocin in the treatment of autism. Also, there are very few, if any, outcome measures to assess social functioning in the "real world" in the context of clinical trials; yet, this is a major target for intervention, especially in autism. Thus, a final goal of this study will be to explore the use of Event Contingent Recording (ECR) to index changes in social functioning and affect. ECR is a methodology developed by personality/social psychologists, which allows participants to report on symptoms, affect, and behavior close in time to experience. In addition, to enabling more sensitive assessments, this methodology allows for the assessment of more diverse (e.g., at home versus work) and more detailed measurements of mood and behavior. Finally, a portion of this study aims to perform gene expression profiling using fresh whole blood to explore the molecular mechanisms underlying oxytocin therapy and oxytocin efficacy in adults with high functioning autism or Asperger's syndrome. The systemic effects of oxytocin therapy and the molecular basis for a positive treatment response to oxytocin are not well understood. An understanding of the former may help predict those persons who may suffer side-effects from treatment and the latter may help provide easily accessible peripheral biomarkers that could predict treatment response.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jessica Cuellar, BA | 212-241-2993 | Jessica.cuellar@mssm.edu |
United States, New York | |
Mount Sinai School of Medicine | Recruiting |
New York, New York, United States, 10029-6574 | |
Principal Investigator: Evdokia Anagnostou, MD | |
Sub-Investigator: Jennifer Bartz, PhD |
Principal Investigator: | Evdokia Anagnostou, MD | Mount Sinai School of Medicine |
Study ID Numbers: | GCO#: 06-0230 0001 02 PS* |
Study First Received: | June 22, 2007 |
Last Updated: | February 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00490802 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Autism Treatment Oxytocin Adults Autism Spectrum Disorder |
Developmental Disabilities Child Development Disorders, Pervasive Mental Disorders Autistic Disorder |
Mental Disorders Diagnosed in Childhood Autism Oxytocin |
Child Development Disorders, Pervasive Oxytocics Mental Disorders Autistic Disorder Therapeutic Uses |
Physiological Effects of Drugs Mental Disorders Diagnosed in Childhood Reproductive Control Agents Pharmacologic Actions Oxytocin |