Attention Deficit Hyperactivity DisorderNCT03901859
Metabolic Pathway of Tryptophan and Executive Dysfunction in Children With Attention Deficit Hyperactivity Disorder
An observational study of Attention Deficit Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The present project is to identify the relationship between ADHD and the metabolites of tryptophan. 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 Apr 2019to 31 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: 120 drug-naïve patients with ADHD, aged 7 to 18 years, will be enrolled. Another 120 healthy participants with matched age and sex will be enrolled in the control group.
The ADHD group
- Inclusion Criteria Patients with ADHD are eligible to be included in this study only if they meet all of the following criteria:
- Patients will be outpatients who are between 7 and 18 years of age.
- Patients must have ADHD that meet the Diagnostic and Statistical Manual of Mental disorders, 5th edition (DSM-V) disease diagnostic criteria assessed by the investigator's clinical evaluation, as well as confirmed by the Chinese version of the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Epidemiological Version (K-SADS-E).
- Patients must have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score > 4 at baseline.
- Patients must be psychotropic drug-naïve. Patients will be considered to be drug-naïve if they have never received medications specifically to treat ADHD.
- Patients and parents (or legal representative) must have a degree of understanding sufficient to be able to communicate suitably with the investigator.
- Patients must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as achieving a score of 80 or more when IQ testing is administrated.
- Patients must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including neuropsychological testing and venipunctures.
- Exclusion Criteria
Patients will be excluded from the study if they meet any of the following criteria:
- Patients with current or past history of schizophrenia, schizoaffective Disorder, organic psychosis, bipolar I or II disorder, autism, or autism spectrum disorder. Other comorbid psychiatric disorders are not excluded if the ADHD symptoms are the primary source of impairment for the patient.
- Patients with a history of any seizure disorder (other than febrile convulsion) or patients who are taking anticonvulsants for seizure control.
- Patients have been at serious suicidal risk, determined by the investigator.
- Patients with a history of alcohol or drug abuse within the past 3 months, or who are currently using alcohol, drugs of abuse, or any described or over-the-counter medication in a manner that the investigator considers indicative of abuse.
- Patients with cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure.
- Patients who are likely to need Chinese medicine or health-food supplements that have central nervous system activity.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 110
Chi-Yung Shang, MDPHD, 02-23123456 ext. 66965, cyshang@ntu.edu.tw
About this study
Official title: A Study on the Metabolic Pathway of Tryptophan and Executive Dysfunction in Children With Attention Deficit Hyperactivity Disorder
The present project is to identify the relationship between ADHD and the metabolites of tryptophan.
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. According to investigators previous work, participants with ADHD have executive dysfunction. Previous studies show that tryptophan is associated with cognitive problems in participants. Analyzing differences in tryptophan metabolites (Indolepropionic acid [IPA], indoleacetic acid [IAA], and kynurenic acid [KYNA]) between participants with ADHD and healthy controls could provide insight into underlying disease pathology of cognitive deficits. In this one-year project, investigators will perform an analysis of tryptophan metabolites in serum to identify potential biomarkers for the executive dysfunction of ADHD.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, tryptophan, executive function
- 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 |
|---|---|---|
| Patients with ADHD | drug-naive patients with ADHD, aged 7-18 year old | |
| Healthy Controls | drug-naive healthy controls, aged 7-18 year old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum level of Indolepropionic acid [IPA]
tryptophan metabolite
Measured: 1 year
Serum level of indoleacetic acid [IAA]
tryptophan metabolite
Measured: 1 year
Serum level of kynurenic acid [KYNA]
tryptophan metabolite
Measured: 1 year
Secondary outcomes (8)
ADHD Rating Scale-IV
behavioral measures
Measured: 1 year
Swanson, Nolan, and Pelham IV scale
The SNAP-IV is a 26-items scale, consisting of the DSM-IV symptoms for the Inattention (Item 1-9) and the Hyperactivity/Impulsivity domains (Item 10-18) of the criteria for ADHD, and the oppositional symptoms (Item 19-26) of the criteria for ODD (20). As in the DSM-IV criteria, to describe psychopathology, the word "often" is included at the beginning of each item, so the precise interpretation of the 4-point rating scale (0 = "not at all", 2 = "just a little", 3 = "quite a bit", and 4 = "very much") reflects the degree that the behavior is abnormally frequent and severe compared to normal childhood behavior.
Measured: 1 year
Achenbach Child Behavior Checklist
designed to assess the competencies and behavioral/emotional problems in children 4-18 for CBCL. rate how true each item is at present or within the last 6 months, using a 3-point response scale. subdivided into a profile report on child's standing in competence items and in 112 problem items. Internalizing score is composed of scores for anxiety/depression, somatic complaints, and withdrawal. Externalizing score is comprised of scores for delinquent behavior and aggressive behavior.
Measured: 1 year
Clinical Global Impressions-ADHD-Severity
The CGI-ADHD-S (120) is a single item clinician rating of the assessment of the global severity of the ADHD symptoms in relation to the clinician's total experience with ADHD patients. Severity is rated on a 7-point scale (1=normal, not at all ill; 7=among the most extremely ill patients). The CGI-ADHD-S will be administered on each visit, from visit 1 through visit 10.
Measured: 1 year
Social Adjustment Inventory for Children and Adolescents
The SAICA is a 77-item semi-structured interview scale that was designed for administration to school-aged children aged 6-18 about themselves, or to their parents about their children (121). The SAICA provides an evaluation of children's current functioning in the domains of (1) school, (2) spare time, (3) peer relations, and (4) home behaviors. A higher mean score (items rated on 4-point Likert scale from 1 to 4) indicates either poorer social function or a more severe social problem (121). (We delete the Spare time relationship in the Overall relationship) The score for each item ranges from 1 to 4. An increased score indicates either a decreased social function or an increased severity of social problem.
Measured: 1 year
Chinese version of the Family Adaptation, Partnership, Growth, Affection, and Resolve
behavioral measures
Measured: 1 year
Cambridge Neuropsychological Test Automated Batteries
neuropsychological measures
Measured: 1 year
Continuous Performance Test
neuropsychological measures
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Apr 2019
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
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 (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi-Yung Shang, MDPHD, Principal investigator, Dept of Psychiatry, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901859
- Sponsor's protocol ID
- 201809043RINA
- Status last verified
- Nov 2018
- First submitted
- 28 Mar 2019
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Metabolic Pathway of Tryptophan and Executive Dysfunction in Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03901859
- Acronym / sponsor ID
- 201809043RINA
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, tryptophan, executive function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 3 Apr 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.
The present project is to identify the relationship between ADHD and the metabolites of tryptophan.
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. According to investigators previous work, participants with ADHD have executive dysfunction. Previous studies show that tryptophan is associated with cognitive problems in participants. Analyzing differences in tryptophan metabolites (Indolepropionic acid [IPA], indoleacetic acid [IAA], and kynurenic acid [KYNA]) between participants with ADHD and healthy controls could provide insight into underlying disease pathology of cognitive deficits. In this one-year project, investigators will perform an analysis of tryptophan metabolites in serum to identify potential biomarkers for the executive dysfunction of ADHD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with ADHD | – | –drug-naive patients with ADHD, aged 7-18 year old |
| Healthy Controls | – | –drug-naive healthy controls, aged 7-18 year old |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 120 drug-naïve patients with ADHD, aged 7 to 18 years, will be enrolled. Another 120 healthy participants with matched age and sex will be enrolled in the control group.
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
Serum level of Indolepropionic acid [IPA]
Time frame: 1 year
tryptophan metabolite
Serum level of indoleacetic acid [IAA]
Time frame: 1 year
tryptophan metabolite
Serum level of kynurenic acid [KYNA]
Time frame: 1 year
tryptophan metabolite
8 secondary outcomes
ADHD Rating Scale-IV
Time frame: 1 year
Swanson, Nolan, and Pelham IV scale
Time frame: 1 year
Achenbach Child Behavior Checklist
Time frame: 1 year
Clinical Global Impressions-ADHD-Severity
Time frame: 1 year
Social Adjustment Inventory for Children and Adolescents
Time frame: 1 year
Chinese version of the Family Adaptation, Partnership, Growth, Affection, and Resolve
Time frame: 1 year
Cambridge Neuropsychological Test Automated Batteries
Time frame: 1 year
Continuous Performance Test
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 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.
Chi-Yung 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?
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?
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 3 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chi-Yung Shang (02-23123456 ext. 66965, cyshang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum level of Indolepropionic acid [IPA] (time frame: 1 year). The study lists 3 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 3 May 2019.