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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434366
Recruitment Status : Suspended (The effects are not good)
First Posted : February 15, 2018
Last Update Posted : April 12, 2022
Sponsor:
Information provided by (Responsible Party):
Ying Jun She, MD, Guangzhou Women and Children's Medical Center

Tracking Information
First Submitted Date  ICMJE January 28, 2018
First Posted Date  ICMJE February 15, 2018
Last Update Posted Date April 12, 2022
Actual Study Start Date  ICMJE January 20, 2018
Estimated Primary Completion Date December 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
autism behavior checklist(ABC) [ Time Frame: 2 weeks, 4 weeks,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 History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2018)
  • 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)
  • 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)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
  • magnetic resonance spectroscopy(MRS) [ Time Frame: 2 weeks, 4 weeks,12 weeks ]
    compare the metabolite concentrations and ratios in brain from Baseline to Endpoint(NAA,GLU,GLX,Cho,Cr,MI)
  • Childhood Autism Rating Scale (CARS) [ Time Frame: 2 weeks, 4 weeks,12 weeks ]
    Change in CARS from Baseline to Endpoint.CARS is a 15-item behavioural rating scale developed to diagnose autism in combination with clinical judgment.
  • Autism Treatment Evaluation Checklist (ATEC) [ Time Frame: 2 weeks, 4 weeks,12 weeks ]
    Change in ATEC from Baseline to Endpoint. ATEC consists of four subsets scales: I) speech/language/ communication (14 items-score range from 0 to28); II) sociability (20 items- score range from 0 to 40); III) sensory/ cognitive awareness (18 items- score range from 0 to 36); and IV) health/physical (25 items- score range from 0 to 75).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Ketamine With Dexmedetomidine for the Treatment of Children With Autism Spectrum Disorder
Official Title  ICMJE Intranasal Ketamine With Dexmedetomidine for the Treatment of Children With Autism Spectrum Disorder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE
  • Drug: ketamine and dexmedetomidine
    intranasal ketamine and dexmedetomidine for treatment for autism spectrum disorder
    Other Name: intranasal ketamine and dexmedetomidine
  • Drug: ketamine
    intranasal ketamine for treatment for autism spectrum disorder
    Other Name: intranasal ketamine
  • Drug: Saline
    intranasal saline for treatment for autism spectrum disorder
    Other Name: intranasal saline
Study Arms  ICMJE
  • Experimental: ketamine and dexmedetomidine group
    intranasal ketamine and dexmedetomidine was treated in the children
    Intervention: Drug: ketamine and dexmedetomidine
  • Experimental: ketamine group
    intranasal ketamine was treated in the children
    Intervention: Drug: ketamine
  • Placebo Comparator: control group
    intranasal insaline was used in the children
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: February 9, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2023
Estimated Primary Completion Date December 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03434366
Other Study ID Numbers  ICMJE intranasal ketamine
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Ying Jun She, MD, Guangzhou Women and Children's Medical Center
Original Responsible Party Ying-Jun She, Guangzhou Women and Children's Medical Center, Department of Anesthesiology
Current Study Sponsor  ICMJE Guangzhou Women and Children's Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Qing Zhao, Doctor Guangzhou Women and Children's Medical Center
PRS Account Guangzhou Women and Children's Medical Center
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP