NCT02611921

Study of Intranasal Ketamine for Social Impairment in Autism Spectrum Disorder

Intranasal Ketamine Use in Autism Spectrum Disorder: A Placebo-Controlled Crossover Pilot Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 12 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine if intranasal ketamine shows initial evidence of safety, tolerability and efficacy for the treatment of social impairment in individuals with Autism Spectrum Disorder.

Detailed description

To address the significant need for effective treatment of core symptoms of Autism Spectrum Disorder (ASD), this trial is designed as a double-blind, placebo-controlled crossover pilot study of intranasal ketamine in 24 individuals with ASD ages 12- 30 years using a novel quantitative eye-tracking outcome measure to assess impact of the drug on social impairment. Additionally, to develop a ketamine-focused personalized medicine approach in ASD, the investigators will include pharmacokinetic, molecular pharmacodynamic, and electrophysiological assessments into initial systematic study.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Ketamine	Ketamine will be compounded into a mucosal atomization device and self-administered or administered with assistance of a caregiver/study coordinator
DRUG	Placebo	Placebo will delivered as an atomized saline spray which will be self-administered or administered with assistance of a caregiver/study coordinator

Timeline

• Start date: 2015-12-22
• Primary completion: 2018-05-07
• Completion: 2018-05-07
• First posted: 2015-11-23
• Last updated: 2018-10-12

Locations

1 site across 1 country: United States