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

Dextromethorphan Added on for Children With Chronic Irritability

Study Overview

• Status: Enrolling by invitation
• Conditions: Irritable Mood
• Intervention / Treatment: Drug: Dextromethorphan; Other: placebo

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital, National Defense Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Irritability severity	The investigators will measure if the severity improve after using regrow by the ARI scale.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADHD severity	The investigators will measure if the severity improve after using regrow with regular drug by the SNAP-IV scale.	8 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2021
• Primary Completion (Anticipated): April 5, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: September 6, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Respiratory System Agents; Antitussive Agents; Dextromethorphan
• Other Study ID Numbers: 2-108-05-085

Drug and device information, study documents

• 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