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

Primary Purpose

Autism Spectrum Disorder

Status
Suspended
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ketamine and dexmedetomidine
ketamine
Saline
Sponsored by
Guangzhou Women and Children's Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, ketamine, dexmedetomidine

Eligibility Criteria

2 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Guangzhou Women and Children Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ketamine and dexmedetomidine group

ketamine group

control group

Arm Description

intranasal ketamine and dexmedetomidine was treated in the children

intranasal ketamine was treated in the children

intranasal insaline was used in the children

Outcomes

Primary Outcome Measures

Autism Diagnostic Interview Revised (ADI-R)
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.
Autism Diagnostic Observation Schedule (ADOS)
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.

Secondary Outcome Measures

autism behavior checklist (ABC)
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)
magnetic resonance spectroscopy(MRS)
compare the metabolite concentrations and ratios in brain from Baseline to Endpoint (NAA,Glu,Gln,Cho,Cr,mI)
Childhood Autism Rating Scale (CARS)
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.

Full Information

First Posted
January 28, 2018
Last Updated
April 5, 2022
Sponsor
Guangzhou Women and Children's Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03434366
Brief Title
Intranasal Ketamine With Dexmedetomidine for the Treatment of Children With Autism Spectrum Disorder
Official Title
Intranasal Ketamine With Dexmedetomidine for the Treatment of Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Suspended
Why Stopped
The effects are not good
Study Start Date
January 20, 2018 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Women and Children's Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum Disorder, ketamine, dexmedetomidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ketamine and dexmedetomidine group
Arm Type
Experimental
Arm Description
intranasal ketamine and dexmedetomidine was treated in the children
Arm Title
ketamine group
Arm Type
Experimental
Arm Description
intranasal ketamine was treated in the children
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
intranasal insaline was used in the children
Intervention Type
Drug
Intervention Name(s)
ketamine and dexmedetomidine
Other Intervention Name(s)
intranasal ketamine and dexmedetomidine
Intervention Description
intranasal ketamine and dexmedetomidine for treatment for autism spectrum disorder
Intervention Type
Drug
Intervention Name(s)
ketamine
Other Intervention Name(s)
intranasal ketamine
Intervention Description
intranasal ketamine for treatment for autism spectrum disorder
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
intranasal saline
Intervention Description
intranasal saline for treatment for autism spectrum disorder
Primary Outcome Measure Information:
Title
Autism Diagnostic Interview Revised (ADI-R)
Description
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.
Time Frame
change from baseline at 2, 5 and 12 weeks
Title
Autism Diagnostic Observation Schedule (ADOS)
Description
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.
Time Frame
change from baseline at 2, 5 and 12 weeks
Secondary Outcome Measure Information:
Title
autism behavior checklist (ABC)
Description
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)
Time Frame
change from baseline at 2, 5 and 12 weeks
Title
magnetic resonance spectroscopy(MRS)
Description
compare the metabolite concentrations and ratios in brain from Baseline to Endpoint (NAA,Glu,Gln,Cho,Cr,mI)
Time Frame
change from baseline at 5 and 12 weeks
Title
Childhood Autism Rating Scale (CARS)
Description
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.
Time Frame
change from baseline at 2, 5 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: meet autism diagnostic criteria based on DSM-5/ADI-R/ADOS children aged 2 years through 15 years of age parents/guardians can cooperate with the study and sign informed consent ASA score I or II Exclusion Criteria: with epilepsy or other genetic diseases changes in drugs or in any intervention during the study Presence of cardiac disease including coronary artery disease, congestive heart failure, or uncontrolled hypertension per medical history Airway instability, tracheal surgery, or tracheal stenosis per medical history. History of drug or alcohol abuse Central nervous system masses or hydrocephalus per medical history
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qing Zhao, Doctor
Organizational Affiliation
Guangzhou Women and Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Women and Children Medical Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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