drugset / Trial / NCT01908205
Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism Spectrum Disorders (ASD)
Phase 2
Completed
60 enrolled
Holland Bloorview Kids Rehabilitation Hospital
United States Department of Defense · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
We are studying an investigational drug called intranasal oxytocin (Syntocinon®). Syntocinon® has been approved by the U.S. Food and Drug Administration for use in helping women breastfeed, but it has not been approved for use in children with ASD. However, there is previous research conducted that has indicated that after administration of oxytocin, adults with ASD demonstrated improvements in social cognition, and reduced repetitive behaviours and anxiety. There is also early research to suggest that children may also benefit in these areas. The purpose of this study is to test if oxytocin works to help children and adolescents with ASD.
Timeline
- Start
- 2013-09
- Primary completion
- 2015-09
- Completion
- 2016-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxytocin | Peptide | 0.4 iu/kg | Intranasal |