Attention-deficit/Hyperactivity DisorderNCT02942225
The Metabolome Profiling and Pathway Analysis of ADHD
An observational study of Attention-deficit/Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to understand the pathophysiological mechanisms of ADHD, especially the metabolomic pathway related to the behavioral/neuropsychological deficits of ADHD. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention-deficit/Hyperactivity Disorder
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2016to 19 Mar 2020
- 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 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: We plan to recruit 120 ADHD subjects and 120 control subjects.
Who may be able to join
- Subjects without any current or lifetime DSM-V psychiatric disorders based on the K-SADS-E interviews.
Who cannot join
- Participants who had any past or current medical or neurological illness, who currently took psychotropic medication, or whose intelligence quotient (IQ) score was less than 80 were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to understand the pathophysiological mechanisms of ADHD, especially the metabolomic pathway related to the behavioral/neuropsychological deficits of ADHD.
To identify specific metabolites that show significant differences between ADHD and control groups, both liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry will be performed. In addition, the behavioral measures include ADHDRS-IV, SNAP-IV, CBCL, CGI-ADHD-S, SAICA, and Family APGAR-C. Neuropsychological testing, including CPT and CANTAB, will be performed. Conditional logistic regression and partial least squares discriminant analysis will be applied to identify significant metabolites for ADHD. Pathway enrichment and topology analyses will be conducted to evaluate the regulated pathways.
Read the detailed description
Because attention deficit hyperactivity disorder (ADHD) is an early onset and long-term impairing disorder with tremendous impact on individuals, families, and societies, detection and diagnosis are very important for ADHD. Current diagnosis of ADHD relies mainly on clinical observation and interview tools that may involve a great subjective variability, and thus the investigation of objective biomarkers for ADHD is warranted. Metabolomics is the study of a biologic process involving all metabolites that are end products of the cellular process in a whole organism. Because metabolites represent the downstream expression of genome, transcriptome, and proteome, metabolomic profiles are more proximal to the behavioral phenotypes of ADHD. Analyzing metabolic differences between children with ADHD and healthy controls will provide insight into underlying disease pathology. To date, there has been no metabolomics study on ADHD. In this 3-year project, the investigators will perform a metabolomics analysis of serum to identify potential biomarkers for the behavioral and neuropsychological deficits of ADHD.
This is a 3-year project. After careful calculation of sample size, the investigators will recruit 120 drug-naïve children with ADHD, aged 7-18, and 120 healthy controls with matched age, sex and BMI. Using both liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry, serum-based metabolomic profiling will be performed. The behavioral measures include ADHDRS-IV, SNAP-IV, CBCL, CGI-ADHD-S, SAICA, and Family APGAR-C. Neuropsychological testing, including CPT and CANTAB, will be performed. Conditional logistic regression and partial least squares discriminant analysis will be applied to identify significant metabolites for ADHD. Pathway enrichment and topology analyses will be conducted to evaluate the regulated pathways.
Using a matched study design, the investigators anticipate to identify specific metabolites that show significant differences between ADHD and control groups. In addition, results of pathway analysis may offer more biological understanding in explaining the underlying metabolic regulation among children with ADHD. This findings will significantly contribute to the knowledge of the pathophysiological mechanisms of ADHD, especially the metabolomic pathway related to the behavioral/neuropsychological deficits of ADHD.
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Keywords
- Attention-deficit/hyperactivity disorder, metabolomics, neuropsychological deficits, pathway analysis
- 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.
| Study group | Role | What they receive |
|---|---|---|
| ADHD group | Subjects with clinical diagnosis of ADHD according to the DSM-V criteria | |
| TD group | Typically development controls without lifetime diagnosis with ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric interview
Subjects will be interviewed by Chinese Version of the Kiddie Epidemiologic version of the Schedule for Affective Disorders and Schizophrenia (K-SADS-E)
Measured: 1 hour
Secondary outcomes (1)
Spatial working memory
Subjects will be assessed by the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Measured: 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start1 Aug 2016
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi-Yung Shang, MD, Principal investigator, Dept of Psychiatry, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942225
- Sponsor's protocol ID
- 201601035RINA
- Status last verified
- Mar 2020
- First submitted
- 20 Oct 2016
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolome Profiling and Pathway Analysis of ADHD
- ClinicalTrials.gov ID
- NCT02942225
- Acronym / sponsor ID
- 201601035RINA
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Keywords
- Attention-deficit/hyperactivity disorder, metabolomics, neuropsychological deficits, pathway analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 24 Oct 2016 (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.
The purpose of this study is to understand the pathophysiological mechanisms of ADHD, especially the metabolomic pathway related to the behavioral/neuropsychological deficits of ADHD.
To identify specific metabolites that show significant differences between ADHD and control groups, both liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry will be performed. In addition, the behavioral measures include ADHDRS-IV, SNAP-IV, CBCL, CGI-ADHD-S, SAICA, and Family APGAR-C. Neuropsychological testing, including CPT and CANTAB, will be performed. Conditional logistic regression and partial least squares discriminant analysis will be applied to identify significant metabolites for ADHD. Pathway enrichment and topology analyses will be conducted to evaluate the regulated pathways.
Detailed description
Because attention deficit hyperactivity disorder (ADHD) is an early onset and long-term impairing disorder with tremendous impact on individuals, families, and societies, detection and diagnosis are very important for ADHD. Current diagnosis of ADHD relies mainly on clinical observation and interview tools that may involve a great subjective variability, and thus the investigation of objective biomarkers for ADHD is warranted. Metabolomics is the study of a biologic process involving all metabolites that are end products of the cellular process in a whole organism. Because metabolites represent the downstream expression of genome, transcriptome, and proteome, metabolomic profiles are more proximal to the behavioral phenotypes of ADHD. Analyzing metabolic differences between children with ADHD and healthy controls will provide insight into underlying disease pathology. To date, there has been no metabolomics study on ADHD. In this 3-year project, the investigators will perform a metabolomics analysis of serum to identify potential biomarkers for the behavioral and neuropsychological deficits of ADHD.
This is a 3-year project. After careful calculation of sample size, the investigators will recruit 120 drug-naïve children with ADHD, aged 7-18, and 120 healthy controls with matched age, sex and BMI. Using both liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry, serum-based metabolomic profiling will be performed. The behavioral measures include ADHDRS-IV, SNAP-IV, CBCL, CGI-ADHD-S, SAICA, and Family APGAR-C. Neuropsychological testing, including CPT and CANTAB, will be performed. Conditional logistic regression and partial least squares discriminant analysis will be applied to identify significant metabolites for ADHD. Pathway enrichment and topology analyses will be conducted to evaluate the regulated pathways.
Using a matched study design, the investigators anticipate to identify specific metabolites that show significant differences between ADHD and control groups. In addition, results of pathway analysis may offer more biological understanding in explaining the underlying metabolic regulation among children with ADHD. This findings will significantly contribute to the knowledge of the pathophysiological mechanisms of ADHD, especially the metabolomic pathway related to the behavioral/neuropsychological deficits of ADHD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD group | – | –Subjects with clinical diagnosis of ADHD according to the DSM-V criteria |
| TD group | – | –Typically development controls without lifetime diagnosis with ADHD |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- We plan to recruit 120 ADHD subjects and 120 control subjects.
Key inclusion criteria (1 listed)
- Subjects without any current or lifetime DSM-V psychiatric disorders based on the K-SADS-E interviews.
Key exclusion criteria (1 listed)
- Participants who had any past or current medical or neurological illness, who currently took psychotropic medication, or whose intelligence quotient (IQ) score was less than 80 were excluded.
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
Psychiatric interview
Time frame: 1 hour
Subjects will be interviewed by Chinese Version of the Kiddie Epidemiologic version of the Schedule for Affective Disorders and Schizophrenia (K-SADS-E)
1 secondary outcome
Spatial working memory
Time frame: 1.5 hours
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 4 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Chi-Yung Shang, MD 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?
An observational study of 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?
The sponsor lists 1 inclusion and 1 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 4 Sep 2020. 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?
Psychiatric interview (time frame: 1 hour). 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 4 Sep 2020.