Methylphenidate Adverse ReactionNCT04006548
To Explore the Influence of Appetite Reduction and Medication Effect of Methylphenidate in Patients With Attention-deficit/Hyperactivity Disorder(ADHD) Through Pharmacogenetics.
An observational study of Methylphenidate Adverse Reaction, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
We plan to recruit 200 children and adolescents aged between 6 to 17 years old in two years. Those patients would receive clinical interview by child psychiatrists to diagnose as ADHD and to exclude mental retardation, major psychiatric disorders and medical disorders. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Methylphenidate Adverse Reaction
- How many people
- 110 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2019to 1 Feb 2022
- Phase
- Observational
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and adolescents aged between 6 to 17 years old, diagnosed as ADHD, and recieved methylphenidate treatment.
Who may be able to join
- Age range from 6 years old to17 years old
- Diagnosis of ADHD.
Who cannot join
- mental retardation.
- major psychiatric disorders
- major medical disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Explore the Influence of Appetite Reduction and Medication Effect of Methylphenidate in Patients With Attention-deficit/Hyperactivity Disorder Through Pharmacogenetics.
We plan to recruit 200 children and adolescents aged between 6 to 17 years old in two years. Those patients would receive clinical interview by child psychiatrists to diagnose as ADHD and to exclude mental retardation, major psychiatric disorders and medical disorders. Moreover, we excluded children who ever received ADHD medication treatment more than one year, or received medication in recent 30 days. Initial assessment includes collecting saliva sample, and complete questionnaires (SNAP-IV), clinical rating (CGI-S) and psychological test (CPT-II, WISC-IV, CANTAB). After 1 month methylphenidate treatment, we would evaluate SNAP-IV, CGI-S, CGI-I and Barkley Psychostimulants Side Effects Rating Scale. We also would collect saliva samples to perform appetite related gene phenotyping to see the association between medication side effect and polymorphism of appetite related genes.
- Conditions
- Methylphenidate Adverse Reaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Barkley psychostimulants side effect scale
This scale included 17 most common side-effects of methylphenidate. The occurrence of each side-effect was rated on a Likert scale ranging from 0 (not a problem) to 9 (severe).
Measured: One month methylphenidate use
Clinical Global Impression scale-Improvement (CGI-I)
This scale was used to evaluate the improvement after medication treatment. It's a Likert scale range from 1 (very much improved) through to 7 (very much worse).
Measured: One month methylphenidate use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Jul 2019
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methylphenidate Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006548
- Sponsor's protocol ID
- CGMH-IRB-201900009B0
- Status last verified
- Feb 2022
- First submitted
- 2 Jul 2019
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Influence of Appetite Reduction and Medication Effect of Methylphenidate in Patients With Attention-deficit/Hyperactivity Disorder Through Pharmacogenetics.
- ClinicalTrials.gov ID
- NCT04006548
- Acronym / sponsor ID
- CGMH-IRB-201900009B0
- Conditions
- Methylphenidate Adverse Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 5 Jul 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.
We plan to recruit 200 children and adolescents aged between 6 to 17 years old in two years. Those patients would receive clinical interview by child psychiatrists to diagnose as ADHD and to exclude mental retardation, major psychiatric disorders and medical disorders. Moreover, we excluded children who ever received ADHD medication treatment more than one year, or received medication in recent 30 days. Initial assessment includes collecting saliva sample, and complete questionnaires (SNAP-IV), clinical rating (CGI-S) and psychological test (CPT-II, WISC-IV, CANTAB). After 1 month methylphenidate treatment, we would evaluate SNAP-IV, CGI-S, CGI-I and Barkley Psychostimulants Side Effects Rating Scale. We also would collect saliva samples to perform appetite related gene phenotyping to see the association between medication side effect and polymorphism of appetite related genes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and adolescents aged between 6 to 17 years old, diagnosed as ADHD, and recieved methylphenidate treatment.
Key inclusion criteria (2 listed)
- Age range from 6 years old to17 years old
- Diagnosis of ADHD.
Key exclusion criteria (3 listed)
- mental retardation.
- major psychiatric disorders
- major medical disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Barkley psychostimulants side effect scale
Time frame: One month methylphenidate use
This scale included 17 most common side-effects of methylphenidate. The occurrence of each side-effect was rated on a Likert scale ranging from 0 (not a problem) to 9 (severe).
Clinical Global Impression scale-Improvement (CGI-I)
Time frame: One month methylphenidate use
This scale was used to evaluate the improvement after medication treatment. It's a Likert scale range from 1 (very much improved) through to 7 (very much worse).
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 18 Feb 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Methylphenidate Adverse Reaction, run by Chang Gung Memorial 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?
The sponsor lists 2 inclusion and 3 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: finished, as of the sponsor's last update on 18 Feb 2022. 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?
Barkley psychostimulants side effect scale (time frame: One month methylphenidate use). The study lists 2 primary outcomes in all. 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 18 Feb 2022.