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.
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 |
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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
Location
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