Clinical trial NCT03434366: 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
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
ketamine
dexmedetomidine
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Autism Diagnostic Interview Revised (ADI-R)
timeFrame: change from baseline at 2, 5 and 12 weeks
measure: Autism Diagnostic Observation Schedule (ADOS)
timeFrame: change from baseline at 2, 5 and 12 weeks
Secondary outcomes:
measure: autism behavior checklist (ABC)
timeFrame: change from baseline at 2, 5 and 12 weeks
measure: magnetic resonance spectroscopy(MRS)
timeFrame: change from baseline at 5 and 12 weeks
measure: Childhood Autism Rating Scale (CARS)
timeFrame: change from baseline at 2, 5 and 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children Medical Center
state: Guangdong
Study officials:
affiliation: Guangzhou Women and Children's Medical Center
name: Qing Zhao, Doctor
role: PRINCIPAL_INVESTIGATOR
References: