NCT05043805

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Tri-Service General Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Dextromethorphan	add on therapy
OTHER	placebo	add on therapy

Timeline

• Start date: 2021-05-09
• Primary completion: 2024-04-05
• Completion: 2024-06-30
• First posted: 2021-09-14
• Last updated: 2023-04-12

Locations

1 site across 1 country: Taiwan