Study of Intranasal Ketamine for Social Impairment in Autism Spectrum Disorder

Brief 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.

Intervention / Treatment

  • Drug: Ketamine
  • Drug: Placebo

Condition or Disease

  • Autism Spectrum Disorder

Phase

Study Design

Study type: Interventional
Status: Completed
Study results: No Results Available
Age: 12 Years to 30 Years   (Child, Adult)
Enrollment: 21 ()
Funded by: Other|Industry

Masking

Clinical Trial Dates

Start date: Dec 22, 2015
Primary Completion: May 07, 2018
Completion Date: May 07, 2018
Study First Posted: Nov 23, 2015
Results First Posted: Aug 31, 2020
Last Updated: Oct 12, 2018

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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.

Eligibility Criteria

Sex: All
Minimum Age: 12
Maximum Age: 30

More Details

NCT Number: NCT02611921
Other IDs: 2015-2494
Study URL: https://ClinicalTrials.gov/show/NCT02611921
Last updated: Jun 17, 2022