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Dextromethorphan Added on for Children With Chronic Irritability

Sponsor
Tri-Service General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05043805
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
8.6
Anticipated Duration (Months)
13.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Dextromethorphan Added on for Children With Chronic Irritability

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Objectives:

It is known that the etiology and mechanism of neuropsychiatric diseases may be related to nerve inflammation. It has been found that dextromethorphan (DM) is an active ingredient in cough-remedies, which can protect neurons in glial cell cultures in the rat brain from inflammatory substances. Although the mechanism of DM is still unknown, it may be related to the regulation of immune dysfunction. Therefore the purpose of this present study was to investigate the adjuvant treatment with DM in the children and adolescents with chronic irritability.

Methods:

This randomized double-blind clinical trial will evaluate 120 outpatients, aged between 7 and 17 years, with chronic irritability. The study subjects will be randomly assigned into one of the two groups: receiving routine medicine plus DM or routine medicine plus placebo for 8 weeks. Assessments comprising the parents' reported Mood Disorder Questionnaire (MDQ), Affective Reactivity Index (ARI), the Chinese version of the Child Behavior Checklist (CBCL-C) scale, the Swanson, Nolan and Pelham Questionnaire (SNAP-IV), the Sleep Disturbance Scale for Children (SDSC), Problematic smartphone use (PSU) and Checklist for Autism Spectrum Disorder-Chinese Version (CASD-C). Comparison will be done between groups at baseline and at 8 weeks before-and-after the treatment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Study of Risk Factors and Intervention for Children With Chronic Irritability - a Preliminary Approach With Epidemiological, Neuropsychological and Neuroinflammation Studies
Actual Study Start Date :
Nov 10, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dextromethorphan

add on therapy

Drug: Dextromethorphan
add on therapy
Other Names:
  • regrow

    		•
    Placebo Comparator: placebo

    add on therapy

    Other: placebo
    add on therapy

    Outcome Measures

    Primary Outcome Measures

    1. Irritability severity [8 weeks]

      The investigators will measure if the severity improve after using regrow by the ARI scale.

    Secondary Outcome Measures

    1. ADHD severity [8 weeks]

      The investigators will measure if the severity improve after using regrow with regular drug by the SNAP-IV scale.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients aged 7 to 17 who have irritability symptoms will be recruited. They will be screened for the irritability symptoms with ARI scale.
    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tri-Service General Hospital, National Defense Medical Center Taipei Taiwan 114

    Sponsors and Collaborators

    • Tri-Service General Hospital

    Investigators

    • Principal Investigator: Chin-Bin Yeh, M.D., Ph.D., Tri-Service General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chin-Bin Yeh, MD, PhD, Principal Investigator, Professor, Tri-Service General Hospital
    ClinicalTrials.gov Identifier:
    NCT05043805
    Other Study ID Numbers:
    • 2-108-05-085
    First Posted:
    Sep 14, 2021
    Last Update Posted:
    Dec 6, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Dextromethorphan

    Study Results

    No Results Posted as of Dec 6, 2021