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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
Tri-Service General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

6 Years - 25 Years (Child, Adult)All Sexes

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

    First Posted
    February 6, 2013
    Last Updated
    April 25, 2022
    Sponsor
    Tri-Service General Hospital
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    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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