Attention Deficit Hyperactivity DisorderNCT03936491
The Neuroprotective Effects of Methylphenidate and Atomoxetine in Children With ADHD: A Lipidomic Study
A study testing Methylphenidate and Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
1. To identify the difference in the lipidomic profiles between ADHD and controls; 2. To examine the effects of methylphenidate and atomoxetine on the lipidomic profiles in ADHD, and the relationship between medication-related changes in the lipidomic profiles and medication-related improvements in the behavioral… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate and Atomoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2019to 25 Jan 2021
- Phase
- Interventional
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Subjects will be recruited in the present project if they meet the following inclusion criteria:
- Children or adolescents, between 6 and 18 years of age, must have ADHD based on the diagnostic criteria of the Diagnostic and Statistical Manual of Mental disorders, 5th edition.
- Their scores of Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) is greater than 4 at baseline.
- They have to be medication-naïve. They never receive any medication for the treatment of ADHD.
- They and their parents must understand sufficiently to communicate properly with the investigators.
- They must have a Full-Scale Intelligence Quotient (FIQ) score greater than 80.
- They must keep regular clinic visits and all required tests, including collection of blood sample and neuropsychological testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Neuroprotective Effects of Methylphenidate and Atomoxetine in Children With Attention Deficit Hyperactivity Disorder: A Lipidomic Study
- To identify the difference in the lipidomic profiles between ADHD and controls;
- To examine the effects of methylphenidate and atomoxetine on the lipidomic profiles in ADHD, and the relationship between medication-related changes in the lipidomic profiles and medication-related improvements in the behavioral symptoms and neuropsychological functions;
- To map medication-related lipidomic biomolecules to their respective metabolic pathways to identify the underlying mechanisms of neuroprotective effects of methylphenidate and atomoxetine.
Read the detailed description
Background: Although the efficacy of methylphenidate and atomoxetine in ADHD is well documented in clinical trials, more studies are needed to clarify the neuroprotective effects of these two medications. Lipids exert important neuroprotective effects for optimal brain development and functioning. Previous studies have demonstrated the significant connection between lipid dysregulation and the occurrence of ADHD. In addition, lipid dysregulation is closely related to the abnormal neural activity in individuals with ADHD. In this 3-year prospective project, we will perform a lipidomic analysis of blood before and after treatment with methylphenidate or atomoxetine, in order to identify the biological connections between the neuroprotective effects of medications and pathways of lipid metabolism in children with ADHD.
Subjects and Methods: 70 drug-naïve patients with ADHD, aged 6-18, and 35 matched typically developing controls will be recruited in this project. We will randomly assign the 70 ADHD patients to two groups, 35 in the methylphenidate group and 35 in the atomoxetine group. Within the 12-week treatment period, we will use ADHDRS-IV, SNAP-IV, CBCL, YSR, CGI-ADHD-S, CGI-ADHD-I, SAICA, and Family APGAR-C to assess the improvement in the behavioral symptoms, and CPT and CANTAB to assess the improvement in the neuropsychological functioning. The blood sample will be collected, and we will use mass spectrometry to assess the medication-related change in lipidomic profiles.
Anticipated Results: Using a prospective design, we anticipate that this study will delineate the effects of methylphenidate and atomoxetine on the lipidomic profiles in patients with ADHD. Furthermore, we will conduct pathway analysis to obtain crucial insight to the lipidomic regulation in neurophysiology of children with ADHD. We expect that the findings will increase our understanding of the neuroprotective effects of methylphenidate and atomoxetine in patients with ADHD, and identify the psychopharmacological mechanism of medication effects in ADHD via the pathways of lipid metabolism and regulation.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Methylphenidate, Atomoxetine
- Keywords
- biomarker, ADHD
- 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.
MethylphenidateDrug
Also called Ritalin
Methylphenidate is a central nervous system stimulant used for the therapy of attention deficit disorder and narcolepsy.
AtomoxetineDrug
Also called Strattera
Atomoxetine is a medication used to treat attention deficit hyperactivity disorder (ADHD).[6] Use is only recommended in those who are at least six years old.[6] It is taken by mouth.[6]
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate | Experimental | The subjects will receive methylphenidate according to their clinical symptoms Receives: Drug: Methylphenidate |
| Atomoxetine | Active comparator | The subjects will receive atomoxetine according to their clinical symptoms Receives: Drug: Atomoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD Rating Scale-IV-Parent version: Investigator-Administered and Scored (ADHDRS-IV)
The first efficacy measure is the ADHDRS-IV, which is a scale composed of 18 items. The investigator will conduct a semi-structured interview with the parent to evaluate the severity of ADHD symptoms in the past week. ADHDRS-IV is a valid and reliable tool to assess the severity of ADHD symptoms, which has been widely used in pharmacological studies of ADHD in Taiwanese populations. ADHDRS-IV will be administered from visit 1 through visit 5 (baseline-week 12).
Measured: 12 weeks
Secondary outcomes (1)
Swanson, Nolan, and Pelham IV scale (SNAP-IV), Parent Form and Teacher Form
The SNAP-IV is composed of the ADHD symptoms for the inattention (Items 1 to 9), the hyperactivity/impulsivity (Items 10 to 18), and the oppositional symptoms (Items 19 to 26). SNAP-IV has been proved to be a valid and reliable tool to evaluate the severity of ADHD symptoms. The Chinese SNAP-IV has been used widely in the pharmacological studies on ADHD in Taiwanese populations. SNAP-IV will be administered from visit 1 through visit 5 (baseline-week 12).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 Aug 2019
- Primary completion25 Jan 2021
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi-Yung Shang Shang, MDPHD, Principal investigator, Dept of Psychiatry, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936491
- Sponsor's protocol ID
- 201812200MINA
- Status last verified
- Apr 2024
- First submitted
- 2 May 2019
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neuroprotective Effects of Methylphenidate and Atomoxetine in Children With Attention Deficit Hyperactivity Disorder: A Lipidomic Study
- ClinicalTrials.gov ID
- NCT03936491
- Acronym / sponsor ID
- 201812200MINA
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- biomarker, ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 3 May 2019 (actual)
- 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.
- To identify the difference in the lipidomic profiles between ADHD and controls;
- To examine the effects of methylphenidate and atomoxetine on the lipidomic profiles in ADHD, and the relationship between medication-related changes in the lipidomic profiles and medication-related improvements in the behavioral symptoms and neuropsychological functions;
- To map medication-related lipidomic biomolecules to their respective metabolic pathways to identify the underlying mechanisms of neuroprotective effects of methylphenidate and atomoxetine.
Detailed description
Background: Although the efficacy of methylphenidate and atomoxetine in ADHD is well documented in clinical trials, more studies are needed to clarify the neuroprotective effects of these two medications. Lipids exert important neuroprotective effects for optimal brain development and functioning. Previous studies have demonstrated the significant connection between lipid dysregulation and the occurrence of ADHD. In addition, lipid dysregulation is closely related to the abnormal neural activity in individuals with ADHD. In this 3-year prospective project, we will perform a lipidomic analysis of blood before and after treatment with methylphenidate or atomoxetine, in order to identify the biological connections between the neuroprotective effects of medications and pathways of lipid metabolism in children with ADHD.
Subjects and Methods: 70 drug-naïve patients with ADHD, aged 6-18, and 35 matched typically developing controls will be recruited in this project. We will randomly assign the 70 ADHD patients to two groups, 35 in the methylphenidate group and 35 in the atomoxetine group. Within the 12-week treatment period, we will use ADHDRS-IV, SNAP-IV, CBCL, YSR, CGI-ADHD-S, CGI-ADHD-I, SAICA, and Family APGAR-C to assess the improvement in the behavioral symptoms, and CPT and CANTAB to assess the improvement in the neuropsychological functioning. The blood sample will be collected, and we will use mass spectrometry to assess the medication-related change in lipidomic profiles.
Anticipated Results: Using a prospective design, we anticipate that this study will delineate the effects of methylphenidate and atomoxetine on the lipidomic profiles in patients with ADHD. Furthermore, we will conduct pathway analysis to obtain crucial insight to the lipidomic regulation in neurophysiology of children with ADHD. We expect that the findings will increase our understanding of the neuroprotective effects of methylphenidate and atomoxetine in patients with ADHD, and identify the psychopharmacological mechanism of medication effects in ADHD via the pathways of lipid metabolism and regulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate | Experimental | Drug: MethylphenidateThe subjects will receive methylphenidate according to their clinical symptoms |
| Atomoxetine | Active comparator | Drug: AtomoxetineThe subjects will receive atomoxetine according to their clinical symptoms |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| MethylphenidateAlso: RitalinMethylphenidate is a central nervous system stimulant used for the therapy of attention deficit disorder and narcolepsy. | Drug | Methylphenidate |
| AtomoxetineAlso: StratteraAtomoxetine is a medication used to treat attention deficit hyperactivity disorder (ADHD).[6] Use is only recommended in those who are at least six years old.[6] It is taken by mouth.[6] | Drug | Atomoxetine |
Primary outcome
ADHD Rating Scale-IV-Parent version: Investigator-Administered and Scored (ADHDRS-IV)
Time frame: 12 weeks
The first efficacy measure is the ADHDRS-IV, which is a scale composed of 18 items. The investigator will conduct a semi-structured interview with the parent to evaluate the severity of ADHD symptoms in the past week. ADHDRS-IV is a valid and reliable tool to assess the severity of ADHD symptoms, which has been widely used in pharmacological studies of ADHD in Taiwanese populations. ADHDRS-IV will be administered from visit 1 through visit 5 (baseline-week 12).
1 secondary outcome
Swanson, Nolan, and Pelham IV scale (SNAP-IV), Parent Form and Teacher Form
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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.
Chi-Yung Shang Shang, MDPHD principal investigator
Dept of Psychiatry, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylphenidate and Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
ADHD Rating Scale-IV-Parent version: Investigator-Administered and Scored (ADHDRS-IV) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2024.