Dextromethorphan Added on for Children With Chronic Irritability
The Study of Risk Factors and Intervention for Children With Chronic Irritability - a Preliminary Approach With Epidemiological, Neuropsychological and Neuroinflammation Studies
1 other identifier
interventional
120
1 country
1
Brief Summary
Dextromethorphan Added on for Children With Chronic Irritability
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2021
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 9, 2021
CompletedFirst Submitted
Initial submission to the registry
August 27, 2021
CompletedFirst Posted
Study publicly available on registry
September 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedApril 12, 2023
April 1, 2023
2.9 years
August 27, 2021
April 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Irritability severity
The investigators will measure if the severity improve after using regrow by the ARI scale.
8 weeks
Secondary Outcomes (1)
ADHD severity
8 weeks
Study Arms (2)
Dextromethorphan
ACTIVE COMPARATORadd on therapy
placebo
PLACEBO COMPARATORadd on therapy
Interventions
Eligibility Criteria
You may qualify if:
- Patients aged 7 to 17 who have irritability symptoms will be recruited. They will be screened for the irritability symptoms with ARI scale.
You may not qualify if:
- Patients who are not willing to participate in the study after detailed explanation.
- Patients who could not follow the investigator's instructions.
- Patients who have problems to express questions or emotional problems exactly.
- Patients who have severe neurological or mental illness like epileptic disorder, history of stroke, schizophrenia, bipolar disorder, mental retardation or uncontrolled suicide risk.
- Patients who have severe medical illness or surgical conditions like uncontrolled abnormal thyroid function, history of heart attack, uncontrolled hypertension.
- Patients who are allergic to methylphenidate or dextromethorphan.
- Patients with autoimmune disorders
- Patients with asthma or severe infection disorder currently or in the previous two months to avoid the influence of the level of cytokines.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tri-Service General Hospital, National Defense Medical Center
Taipei, 114, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chin-Bin Yeh, M.D., Ph.D.
Tri-Service General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Professor
Study Record Dates
First Submitted
August 27, 2021
First Posted
September 14, 2021
Study Start
May 9, 2021
Primary Completion
April 5, 2024
Study Completion
June 30, 2024
Last Updated
April 12, 2023
Record last verified: 2023-04