Dextromethorphan Added on for the Patients With ADHD (DAOFTPWA)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Dextromethorphan
Sponsored by
About this trial
This is an expanded access trial for Attention Deficit Hyperactivity Disorder
Eligibility Criteria
Inclusion Criteria:
- Patients aged 6 to 25 who have ADHD symptoms will be recruited. They will be screened for the ADHD symptoms with SNAP 4th version. They then will be referred to a psychiatrist to make a final diagnosis of ADHD by the American Diagnostic Statistical Manual 4th version (DSM-IV).
Exclusion Criteria:
- Patients not willing to participate in the study after detailed explanation.
- Patients who could not follow the investigator's instructions
- 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 taking antidepressants, psychotropic medicines within two months prior to the evaluation for entering our study.
- 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01787136
First Posted
February 6, 2013
Last Updated
April 25, 2022
Sponsor
Tri-Service General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01787136
Brief Title
Dextromethorphan Added on for the Patients With ADHD
Acronym
DAOFTPWA
Official Title
Dextromethorphan Added on Methylphenidate in the Treatment of the Patients With ADHD
Study Type
Expanded Access
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital
4. Oversight
5. Study Description
Brief Summary
Dextromethorphan added on methylphenidate for the patients with attention deficit hyperactivity disorder
Detailed Description
Objectives: Methylphenidate (MPH) is highly effective in controlling the symptoms of attention-deficit/hyperactivity disorder (ADHD), but some children with ADHD either do not respond to, or do not tolerate, treatment. Dextromethorphan (DM) is a neuroprotective agent which has been used in the treatment of neuropsychiatric disorders. This clinical trial had examined the effect of DM on the use of MPH in the children with ADHD.
Methods: This randomized double-blind clinical trial had evaluated 44 male outpatients, aged between 6 and 12 years, with a diagnosis of ADHD. The study subjects were randomly assigned into one of the two groups: receiving MPH alone (15-60 mg per day) or MPH plus DM (30-60 mg per day) for 8 weeks. Assessments, comprising the Chinese version of the Child Behavior Checklist (CBCL-C) scale and the Swanson, Nolan and Pelham Questionnaire (SNAP)-IV rating tests conducted by parents and the serum cytokines measured by microarray and enzyme-linked immunosorband assay (ELISA), were compared between groups at baseline and at 8 weeks after the medication was started.
Results: There were a significant decrease at the mean scores of both CBCL-C and SNAP-IV scales after 8 weeks of treatment, but no significant differences between MPH and MPH+DM groups. Compared with the MPH-only group, the mean scores of some psychometric parameters reported on the CBCL-C and SNAP-IV scales regarding time effects as well as the attention problems on the CBCL-C scale regarding group effect were significantly higher in the DM+MPH group. Although there were no significant differences in the levels of various serum cytokines between groups, the subjects in the DM-MPH group had relatively fewer and lower levels of adverse effects. Significant interactions were found between the withdrawn/depression item reported on the CBCL-C scale and tumor necrosis factor α (ခTNF-α) (p = 0.027), as well as between thought problems item on the CBCL-C and TNF-α (p = 0.028) in subjects who had received DM+MPH treatment.
Conclusion: Following the trial, DM+MPH was not superior to MPH alone for the treatment of children with ADHD, yet DM may potentially have negative effects on ADHD symptoms when combined with MPH.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Dextromethorphan
Other Intervention Name(s)
regrow
Intervention Description
added on therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
25 Years
Eligibility Criteria
Inclusion Criteria:
Patients aged 6 to 25 who have ADHD symptoms will be recruited. They will be screened for the ADHD symptoms with SNAP 4th version. They then will be referred to a psychiatrist to make a final diagnosis of ADHD by the American Diagnostic Statistical Manual 4th version (DSM-IV).
Exclusion Criteria:
Patients not willing to participate in the study after detailed explanation.
Patients who could not follow the investigator's instructions
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 taking antidepressants, psychotropic medicines within two months prior to the evaluation for entering our study.
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
31333511
Citation
Chuang WC, Yeh CB, Wang SC, Pan PY, Shyu JF, Liu YP, Gau SS, Lu RB. Potential Negative Effects of Dextromethorphan as an Add-On Therapy to Methylphenidate in Children With ADHD. Front Psychiatry. 2019 Jun 26;10:437. doi: 10.3389/fpsyt.2019.00437. eCollection 2019.
Results Reference
derived
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Dextromethorphan Added on for the Patients With ADHD
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