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

NCT03434366 | Suspended Phase 2 DMC

• 1 other identifier: intranasal ketamine
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; ketamine; dexmedetomidine

Outcome Measures

Primary Outcomes (2)

• 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.

  change from baseline at 2, 5 and 12 weeks

• 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.

  change from baseline at 2, 5 and 12 weeks

Secondary Outcomes (3)

• autism behavior checklist (ABC)

  change from baseline at 2, 5 and 12 weeks

• magnetic resonance spectroscopy(MRS)

  change from baseline at 5 and 12 weeks

• Childhood Autism Rating Scale (CARS)

  change from baseline at 2, 5 and 12 weeks

Study Arms (3)

ketamine and dexmedetomidine group

EXPERIMENTAL

intranasal ketamine and dexmedetomidine was treated in the children

Drug: ketamine and dexmedetomidine

ketamine group

EXPERIMENTAL

intranasal ketamine was treated in the children

Drug: ketamine

control group

PLACEBO COMPARATOR

intranasal insaline was used in the children

Drug: Saline

Interventions

ketamine and dexmedetomidine DRUG

intranasal ketamine and dexmedetomidine for treatment for autism spectrum disorder

Also known as: intranasal ketamine and dexmedetomidine

ketamine and dexmedetomidine group

ketamine DRUG

intranasal ketamine for treatment for autism spectrum disorder

Also known as: intranasal ketamine

ketamine group

Saline DRUG

intranasal saline for treatment for autism spectrum disorder

Also known as: intranasal saline

control group

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead

Study Sites (1)

Guangzhou Women and Children Medical Center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Ketamine; Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Qing Zhao, Doctor

  Guangzhou Women and Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology

Study Record Dates

• First Submitted: January 28, 2018
• First Posted: February 15, 2018
• Study Start: January 20, 2018
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

CN (1)