Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | November 2010 |
| End Date: | December 2013 |
| Contact: | Nadia Tanel, MEd |
| Email: | ntanel@hollandbloorview.ca |
| Phone: | 416 425 6220 |
Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism Spectrum Disorders
Extensive data has been accumulated to suggest that central release of oxytocin is important
for social cognition and function, as well as likely involved in anxiety modulation and
repetitive behaviors. The PI of this study and the PI of the UIC subcontract have
previously documented: 1) an association between ASD and a single nuclear polymorphism of
the oxytocin receptor gene, 2) ability to measure oxytocin levels in the blood by enzyme
immunoassay and 3) preliminary data to support safety and efficacy of intranasal oxytocin in
the treatment of social deficits and repetitive behaviors in adults with autism. A
medication treatment targeting the core deficits of ASD in childhood is highly valuable
because it could influence the developmental trajectory and make further psychosocial
interventions possible. In this context, the investigators propose a randomized placebo
controlled trial of IN oxytocin in youth with ASD, preceded by a small dose finding phase to
confirm that the dose used in the adult study is not more than the maximum tolerated dose in
youth. The investigators hypothesize that IN oxytocin will be superior to placebo in
measures of social cognition (DANVA-2,) and Social function (SRS)
Inclusion Criteria:
- Male or female outpatients12-17 years of age
- Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text
Revision criteria.DSM-IV criteria for Autistic Disorder or Asperger's Disorder will
be established by a clinician with expertise with individuals with ASD. Best
estimate Diagnosis will be reached using DSM_IV criteria, the Autism Diagnostic
Observation Schedule (ADOS-G) and the Autism Diagnostic Interview (ADI-R)
- Have a Clinician's Global Impression-Severity (CGI-S) score ≥ 4 (moderately ill) at
Baseline.
- Full scale IQ >/= 70.
- If already receiving stable non-pharmacologic educational, behavioral, and/or dietary
interventions, have continuous participation during the preceding 3 months prior to
Screening and will not electively initiate new or modify ongoing interventions for
the duration of the study
- Have normal physical examination and laboratory test results at Screening. If
abnormal, the finding(s) must be deemed clinically insignificant by the Investigator.
- The patient must be able to speak and understand English sufficiently to allow for
the completion of all study assessments.
Exclusion Criteria:
- Patients born prior to 35 weeks gestational age.
- Patients with any primary psychiatric diagnosis other than autism at Screening.
- Patients 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.
- Pregnant female patients, sexually active female patients on hormonal birth control
and sexually active females who do not use two types of non-hormonal birth control
- Patients 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.
Patients with evidence or history of malignancy or any significant hematological,
endocrine, cardiovascular (including any rhythm disorder), respiratory, renal,
hepatic, or gastrointestinal disease.
- Patients who are sensitive to Syntocinon or any components of its formulation
- Patients with one or more of the following: HIV, HBV, HCV, hemophilia (bleeding
problems, recent nose and brain injuries), abnormal blood pressure (hypotension or
hypertension), drug abuse, immunity disorder or severe depression.
- Patients taking psychoactive medication(s)
- Patients unable to tolerate venipuncture procedures for blood sampling.
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