NCT03434366

Intranasal Ketamine With Dexmedetomidine for the Treatment of Children With Autism Spectrum Disorder

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Guangzhou Women and Children's Medical Center · Academic / Other
• Sex: All
• Age: 2 Years – 15 Years
• Healthy volunteers: Accepted

Summary

Autism spectrum disorder (ASD) is a life-long neurodevelopmental disorder characterized by qualitative abnormalities in reciprocal social interactions and patterns of communication, and by a restricted, stereotyped, repetitive repertoire of interests and activities. The use of medications in adolescents and young adults with ASD is extremely common. However, few data address the effectiveness and harms of medications specifically in this population. The purpose of the study is to determine the efficacy and safety of intranasal ketamine with dexmedetomidine in children with ASD.

Detailed description

The use of medications in adolescents and young adults with ASD is extremely common. few data address the effectiveness and harms of medications specifically in this population. A previous study reported the first case study demonstrating clinical improvement in mood and eye fixation scores from intranasal ketamine treatment in a "complicated" subject with autism spectrum disorderHowever,The purpose of the study is to determine the efficacy and safety of intranasal ketamine with dexmedetomidine in children with ASD.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	ketamine and dexmedetomidine	intranasal ketamine and dexmedetomidine for treatment for autism spectrum disorder
DRUG	ketamine	intranasal ketamine for treatment for autism spectrum disorder
DRUG	Saline	intranasal saline for treatment for autism spectrum disorder

Timeline

• Start date: 2018-01-20
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2018-02-15
• Last updated: 2022-04-12

Locations

1 site across 1 country: China