Clinical trial NCT05043805: Dextromethorphan Added on for Children With Chronic Irritability
Official title: The Study of Risk Factors and Intervention for Children With Chronic Irritability - a Preliminary Approach With Epidemiological, Neuropsychological and Neuroinflammation Studies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Irritable Mood
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Irritability severity
timeFrame: 8 weeks
Secondary outcomes:
measure: ADHD severity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital, National Defense Medical Center
Study officials:
affiliation: Tri-Service General Hospital
name: Chin-Bin Yeh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: