Dextromethorphan Added on for Children With Chronic Irritability

Irritable Mood Clinical Trial

Official title:

The Study of Risk Factors and Intervention for Children With Chronic Irritability - a Preliminary Approach With Epidemiological, Neuropsychological and Neuroinflammation Studies

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05043805
• Other study ID #: 2-108-05-085
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: May 9, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2023
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dextromethorphan Added on for Children With Chronic Irritability

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: June 30, 2024
• Est. primary completion date: April 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Mood

Intervention

Drug:
• Dextromethorphan
add on therapy

Other:
• placebo
add on therapy

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital, National Defense Medical Center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Irritability severity	The investigators will measure if the severity improve after using regrow by the ARI scale.	8 weeks
Secondary	ADHD severity	The investigators will measure if the severity improve after using regrow with regular drug by the SNAP-IV scale.	8 weeks