Autism Spectrum DisorderPhase 2NCT03434366
Intranasal Ketamine With Dexmedetomidine for the Treatment of Children With Autism Spectrum Disorder
A Phase 2 study testing ketamine and dexmedetomidine, ketamine and Saline in people with Autism Spectrum Disorder, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- ketamine and dexmedetomidine, ketamine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2018to 30 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Women and Children Medical Center
Guangzhou, Guangdong, 510000
About this study
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- ketamine and dexmedetomidine, ketamine, Saline
- Keywords
- Autism Spectrum Disorder, ketamine, dexmedetomidine
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamine and dexmedetomidineDrug
Also called intranasal ketamine and dexmedetomidine
intranasal ketamine and dexmedetomidine for treatment for autism spectrum disorder
ketamineDrug
Also called intranasal ketamine
intranasal ketamine for treatment for autism spectrum disorder
SalineDrug
Also called intranasal saline
intranasal saline for treatment for autism spectrum disorder
| Study group | Role | What they receive |
|---|---|---|
| ketamine and dexmedetomidine group | Experimental | intranasal ketamine and dexmedetomidine was treated in the children Receives: Drug: ketamine and dexmedetomidine |
| ketamine group | Experimental | intranasal ketamine was treated in the children Receives: Drug: ketamine |
| control group | Placebo comparator | intranasal insaline was used in the children Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: change from baseline at 2, 5 and 12 weeks
Secondary outcomes (3)
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)
Measured: change from baseline at 2, 5 and 12 weeks
magnetic resonance spectroscopy(MRS)
compare the metabolite concentrations and ratios in brain from Baseline to Endpoint (NAA,Glu,Gln,Cho,Cr,mI)
Measured: change from baseline at 5 and 12 weeks
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.
Measured: change from baseline at 2, 5 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start20 Jan 2018
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Why it stopped: The effects are not good
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Jun She, MD, Guangzhou Women and Children's Medical Center
- Investigators
- Qing Zhao, Doctor, Principal investigator, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434366
- Sponsor's protocol ID
- intranasal ketamine
- Status last verified
- Apr 2022
- First submitted
- 28 Jan 2018
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Ketamine With Dexmedetomidine for the Treatment of Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03434366
- Acronym / sponsor ID
- intranasal ketamine
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, ketamine, dexmedetomidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The effects are not good
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ketamine and dexmedetomidine group | Experimental | Drug: ketamine and dexmedetomidineintranasal ketamine and dexmedetomidine was treated in the children |
| ketamine group | Experimental | Drug: ketamineintranasal ketamine was treated in the children |
| control group | Placebo comparator | Drug: Salineintranasal insaline was used in the children |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketamine and dexmedetomidineAlso: intranasal ketamine and dexmedetomidineintranasal ketamine and dexmedetomidine for treatment for autism spectrum disorder | Drug | ketamine and dexmedetomidine group |
| ketamineAlso: intranasal ketamineintranasal ketamine for treatment for autism spectrum disorder | Drug | ketamine group |
| SalineAlso: intranasal salineintranasal saline for treatment for autism spectrum disorder | Drug | control group |
Primary outcome
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.
3 secondary outcomes
autism behavior checklist (ABC)
Time frame: change from baseline at 2, 5 and 12 weeks
magnetic resonance spectroscopy(MRS)
Time frame: change from baseline at 5 and 12 weeks
Childhood Autism Rating Scale (CARS)
Time frame: change from baseline at 2, 5 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Zhao, Doctor principal investigator
Guangzhou Women and Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ketamine and dexmedetomidine, ketamine and Saline in people with Autism Spectrum Disorder, run by Guangzhou Women and Children's Medical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism Diagnostic Interview Revised (ADI-R) (time frame: change from baseline at 2, 5 and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.