Dextromethorphan Added on for Children With Chronic Irritability

NCT ID: NCT05043805

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-09
• Study Completion Date: 2024-06-30

Brief Summary

Dextromethorphan Added on for Children With Chronic Irritability

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.

Conditions

Irritable Mood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dextromethorphan

add on therapy

Group Type: ACTIVE_COMPARATOR

Dextromethorphan

Intervention Type: DRUG

add on therapy

placebo

add on therapy

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

add on therapy

Interventions

Dextromethorphan

add on therapy

Intervention Type: DRUG

placebo

add on therapy

Intervention Type: OTHER

Other Intervention Names

regrow

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chin-Bin Yeh, MD, PhD

Principal Investigator, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chin-Bin Yeh, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Locations

Tri-Service General Hospital, National Defense Medical Center

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

2-108-05-085

Identifier Type: -

Identifier Source: org_study_id