autism spectrum disorder
Conditions
Interventions
Intranasal administration of 16 IU/day oxytocin (Syntocinon, Novartis) for twice per day, eight weeks, followed by intranasal administration of placebo for twice per day, eight weeks.
Intranasal admin
Sponsors
Research Center for Child Mental Development, Kanazawa University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Diagnosed as having autistic disorder or pervasive developmental disorder not otherwise specified based on Diagnostic and Statistical Manual of Mental Disorders Forth edition Text revision using Diagnostic Interview for Social and Communication Disorders 2. Intelligence Quotient below 75 3. Possible to be drew blood from a vein
Exclusion criteria
Exclusion criteria: 1. History of allergy for oxytocin 2. History of traumatic brain injury with loss of consciousness for more than 5 minutes 3. Diagnosed as having substance dependence or history of substance dependence 4. History of water intoxication 5. Routinely severe polydipsia 6. Clinical judgment of ineligility for some reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline to post-administration every two weeks on the Childhood Autism Rating Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline to post-administration every two weeks on the Clinical Global Impressions, Aberrant Behavior Checklist, Global Assessment of Functioning, plasma oxytocin concentration and Interaction Rating Scale Advanced | — |
Countries
Japan
Outcome results
None listed