Intranasal Oxytocin for the Treatment of Children and Adolescents With ASD (OXY)

Summary

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 principal investigators of this study have previously documented: 1) an association between Autism Spectrum Disorder 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 Autism Spectrum Disorder in childhood is highly valuable because it could influence the developmental trajectory and make further psychosocial interventions possible. In this context, we propose a small dose finding study to confirm that the dose used in the adult study is not more than the maximum tolerated dose in youth. '

Conditions

• Autism Spectrum Disorder

Interventions

DRUG

Intranasal Oxytocin

We are selecting morning and afternoon dosing to try to influence most hours where youth are in settings with increased potential for social interaction (school, after school). Medication will be administered by the parents before school and early afternoon. All patients will receive their first dose by the study physician to educate parents and themselves on proper administration and determine safety of first dose.

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• Evdokia Anagnostou

  lead INDIV

Principal Investigators

• Evdokia Anagnostou, M.D. · Holland Bloorview Kids Rehabilitation Hospital

• Suma Jacob, M.D., Ph.D. · University of Illinois at Chicago

• Jessica Brian, Ph.D. · Holland Bloorview Kids Rehabilitation Hospital

• Wendy Roberts, M.D. · The Hospital for Sick Children

• Sharon Smile, M.D. · Holland Bloorview Kids Rehabilitation Hospital

• Edwin Cook, M.D. · University of Illinois at Chicago

• Annie Dupuis, Ph.D. · Holland Bloorview Kids Rehabilitation Hospital

• Margot Taylor, Ph.D. · The Hospital for Sick Children

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

10 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-11-30

Primary Completion

2013-03-31

Completion

2013-03-31

Countries

• Canada

Study Locations