Attention Deficit Hyperactivity DisorderDAOFTPWANCT01787136
Dextromethorphan Added on for the Patients With ADHD
A study testing Dextromethorphan in people with Attention Deficit Hyperactivity Disorder, run by Tri-Service General Hospital (TSGH).
Trial summary
Dextromethorphan added on methylphenidate for the patients with attention deficit hyperactivity disorder Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Dextromethorphan
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 25 years
- All sexes
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: Dextromethorphan Added on Methylphenidate in the Treatment of the Patients With ADHD
Dextromethorphan added on methylphenidate for the patients with attention deficit hyperactivity disorder
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Dextromethorphan
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextromethorphanDrug
Also called regrow
added on therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin-Bin Yeh, MD, PhD, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787136
- Sponsor's protocol ID
- TSGH-C97-87
- Acronym
- DAOFTPWA
- Status last verified
- Mar 2021
- First submitted
- 6 Feb 2013
- Last updated
- 29 Apr 2022
- Results posted
- No
Publications
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.
PubMed 31333511
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dextromethorphan Added on Methylphenidate in the Treatment of the Patients With ADHD
- ClinicalTrials.gov ID
- NCT01787136
- Acronym / sponsor ID
- DAOFTPWA / TSGH-C97-87
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DextromethorphanAlso: regrowadded on therapy | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Derived from this study: PubMed 31333511Chuang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dextromethorphan in people with Attention Deficit Hyperactivity Disorder, run by Tri-Service General Hospital (TSGH).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01787136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.