Intranasal Ketamine With Dexmedetomidine for the Treatment of Children With Autism Spectrum Disorder
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|ClinicalTrials.gov Identifier: NCT03434366|
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : July 18, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Drug: ketamine and dexmedetomidine Drug: ketamine Drug: Saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Intranasal Ketamine With Dexmedetomidine for the Treatment of Children With Autism Spectrum Disorder|
|Actual Study Start Date :||January 20, 2018|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
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 Name: intranasal ketamine and dexmedetomidine
Experimental: ketamine group
intranasal ketamine was treated in the children
intranasal ketamine for treatment for autism spectrum disorder
Other Name: intranasal ketamine
Placebo Comparator: control group
intranasal insaline was used in the children
intranasal saline for treatment for autism spectrum disorder
Other Name: intranasal saline
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434366
|Contact: YJ She, Dr.||firstname.lastname@example.org|
|Guangzhou Women and Children Medical Center||Recruiting|
|Guangzhou, Guangdong, China, 510000|
|Contact: Ying-Jun She, Doctor 862038076243 email@example.com|
|Principal Investigator:||Qing Zhao, Doctor||Guangzhou Women and Children's Medical Center|