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

NCT03434366 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-04-12

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Guangzhou Women and Children's Medical Center

    lead OTHER

Principal Investigators

  • Qing Zhao, Doctor · Guangzhou Women and Children's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-20
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03434366 on ClinicalTrials.gov