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

April 5, 2022 updated by: Ying Jun She, MD, Guangzhou Women and Children's Medical Center

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Guangzhou Women and Children Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. meet autism diagnostic criteria based on DSM-5/ADI-R/ADOS
  2. children aged 2 years through 15 years of age
  3. parents/guardians can cooperate with the study and sign informed consent
  4. ASA score I or II

Exclusion Criteria:

  1. with epilepsy or other genetic diseases
  2. changes in drugs or in any intervention during the study
  3. Presence of cardiac disease including coronary artery disease, congestive heart failure, or uncontrolled hypertension per medical history
  4. Airway instability, tracheal surgery, or tracheal stenosis per medical history.
  5. History of drug or alcohol abuse
  6. Central nervous system masses or hydrocephalus per medical history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ketamine and dexmedetomidine group
intranasal ketamine and dexmedetomidine was treated in the children
Drug: ketamine and dexmedetomidine
intranasal ketamine and dexmedetomidine for treatment for autism spectrum disorder
Other Names:
  • intranasal ketamine and dexmedetomidine
Experimental: ketamine group
intranasal ketamine was treated in the children
Drug: ketamine
intranasal ketamine for treatment for autism spectrum disorder
Other Names:
  • intranasal ketamine
Placebo Comparator: control group
intranasal insaline was used in the children
Drug: Saline
intranasal saline for treatment for autism spectrum disorder
Other Names:
  • intranasal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autism Diagnostic Interview Revised (ADI-R)
Time Frame: change from baseline at 2, 5 and 12 weeks
The Autism Diagnostic Interview Revised is an investigator-based semi-structured diagnostic interview, The ADI-R provides empirically derived diagnostic algorithms for three subdomains of qualitative impairments. The social interaction domain includes questions about emotional sharing, offering and seeking comfort, social smiling, and social responding comprising four subscores. The second domain (communication) assesses stereotyped expressions, pronoun reversal, and the social usage of language (B1-B4). In the third domain repetitive and stereotyped behavior as hand- and finger mannerisms, unusual sensory interest or activities are investigated by four subscales. Most items are scored from zero to three, relying on the interviewer to make judgements on child's behaviour based on the recall of information from parents/carers. . A total score is then calculated for each of the three subdomains. The ADI-R has an algorithm for autism based on scores in these three areas and on onset.
change from baseline at 2, 5 and 12 weeks
Autism Diagnostic Observation Schedule (ADOS)
Time Frame: change from baseline at 2, 5 and 12 weeks
The Autism Diagnostic Observation Schedule (ADOS) is a semi-structured assessment of communication, social interaction and play or imaginative use of materials for individuals suspected of having autism or other ASD. It consists of four modules, each of which is appropriate for children, adolescents and adults of differing developmental and language levels, ranging from no expressive or receptive language to verbally fluent adults. The examiner selects the module that is most appropriate for a particular child, adolescent on the basis of his/her expressive language level and chronological age. Selected algorithm items relating to social interaction and communication are then entered into an algorithm. The scores must meet the separate cut-offs for both the communication and social domains and the cut-off for the summation of the two. Repetitive behaviours are recorded and coded as part of the clinical observations but do not contribute to the ADOS summary algorithm.
change from baseline at 2, 5 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
autism behavior checklist (ABC)
Time Frame: change from baseline at 2, 5 and 12 weeks
ABC is a scale used for nonadaptive behaviors created to screen and indicate the probability of a diagnosis of autism. The questionnaire approaches 57 atypical behaviors related to five areas: sensorial, relational, use of body and objects, and social skills. Scales> 67 was diagnosised ASD, compare the change in scales in different time point(from baseline to endpoint)
change from baseline at 2, 5 and 12 weeks
magnetic resonance spectroscopy(MRS)
Time Frame: change from baseline at 5 and 12 weeks
compare the metabolite concentrations and ratios in brain from Baseline to Endpoint (NAA,Glu,Gln,Cho,Cr,mI)
change from baseline at 5 and 12 weeks
Childhood Autism Rating Scale (CARS)
Time Frame: change from baseline at 2, 5 and 12 weeks
CARS assesses the child on a scale from 1 to 4 in each of 15 dimensions or symptoms (including the ability to relate to people, emotional response, imitation, body use, object use, listening response, fear or nervousness, verbal communication, nonverbal communication, activity level, level and reliability of intellectual response, adaptation to changes, visual response, taste, smell and touch responses and general impressions). A total score of at least 30 strongly suggests the presence of autism. Children who score between 30 and 36 have mild-to-moderate autism while those with scores between 37 and 60 have severe autism. Change in CARS from Baseline to Endpoint.
change from baseline at 2, 5 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Women and Children's Medical Center

Investigators

  • Principal Investigator: Qing Zhao, Doctor, Guangzhou Women and Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2018

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

January 28, 2018

First Submitted That Met QC Criteria

February 9, 2018

First Posted (Actual)

February 15, 2018

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Intranasal ketamine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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