Attention Deficit Hyperactivity DisorderNCT02392169
Neuroendocrine Substrates, Candidate Genes and Endophenotypes in ADHD
An observational study of Attention Deficit Hyperactivity Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common child and adolescent psychiatric disorders. In recent years, some researchers have become interested in analyzing neuroendocrine substrate levels in ADHD, including dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEA-S), cortisol… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2013to Jul 2017
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients from Kaohsiung, Taiwan by specialist clinical diagnosis of ADHD.
Who may be able to join
- Patients with ADHD aged between 6 and 16.
- The patients were either newly diagnosed with ADHD or had an existing diagnosis but had not taken medication for ADHD during the previous 6 months or more.
Who cannot join
- Patients with a history of major physical or additional psychiatric diseases .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between the Neuroendocrine Substrates, Candidate Genes and Endophenotypes in Patients With Attention-deficit/Hyperactivity Disorder
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common child and adolescent psychiatric disorders. In recent years, some researchers have become interested in analyzing neuroendocrine substrate levels in ADHD, including dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEA-S), cortisol and testosterone. Previous work in ADHD has established a strong heritable component to the phenotype. The STS gene, SULT2A1 gene and TH gene are associated with the function of DHEA/DHEA-S, and the NR3C1 gene is associated with the regulation of cortisol. Therefore, the relationship between these genes and the etiology of ADHD warrants investigation. Moreover, compared to the phenotype, the endophenotypes of ADHD may be more capable of detecting the underlying neurobiological and hereditary mechanisms. Therefore, this study aims to investigate the relationships between neuroendocrine substrates (DHEA, DHEA-S, cortisol and testosterone), candidate genes (STS gene, SULT2A1 gene, TH gene and NR3C1 gene) and the phenotype and endophenotypes (disease subtypes, neurocognitive function and response to treatment) of ADHD.
To complete this work, we will recruit 300 patients with ADHD (probands) and 600 biological parents of the probands. DNA will be extracted from buccal cells by cheek swab. At baseline, saliva samples of ADHD patients will be collected between 7:00 and 8:00 am using the passive drool method, to analyze the levels of neuroendocrine substrates. The patients will undergo assessment for their clinical symptoms and neurocognitive function. Methylphenidate will then be administered to the patients and the usual practice followed. At week 4 and week 52, procedures similar to those performed at baseline will be repeated.
The results of this study may further elucidate the complexity of the pathophysiology of ADHD. We may determine whether the neuroendocrine system, which contains levels of neuroendocrine substrates and associated genes, plays a crucial role in the phenotype and endophenotypes of ADHD. The information may serve as an important reference for the direction of future study and clinical treatment for patients with ADHD.
Read the detailed description
- We will recruit the patients who meet the criteria for ADHD outlined in the DSM-IV. The diagnosis will be made by a child psychiatrist in a structured interview using the Kiddie Epidemiologic Version of the Schedule for Affective Disorders and Schizophrenia (K-SADS-E ).
- The variables of questionnaire from interview include the personal data as below: Age, gender, family background, the significant pressure on growth, positions and incomes of parents, and the process of mother's pregnant.
- For genotyping analysis, DNA of patients and their biological parents will be collected using cheek swab to collect oral mucosal cells, then put it in the refrigerator at-80°C. The genotyping of STS gene, SULT2A1 gene, TH gene and NR3C1 gene will be identified.
- The saliva of patients with ADHD will be collected by passive drool method at 7:00-8:00 in the morning. The saliva specimen which use to analysis endocrine substance concentration should be placed at - 80 ° C freezer as soon as possible.
- The psychiatrist or psychologist will rate patients' symptom severity of the case. The parents of the patients have to fill in the ASRS, SNAP-IV(parent form) and CBCL. The teacher of the case has to fill in the SNAP-IV(teacher form) and TRF. The patients were administered the computerized CPT in a room dedicated to the testing to minimize the variability of the test conditions.
- After the initial assessment, patients with ADHD will begin to receive methylphenidate (MPH) treatment. Patient care was left to the discretion of the psychiatrists, who were given no treatment instructions and simply encouraged to manage their patients according to usual practice. Dosage and drug form can be adjust through the height and weight of the case and his/her clinical needs. The times and frequency of track back should be reference the clinical needs, patients and their parents' willingness. During the follow-up, non-drug therapy. (e.g. Behavioral therapy, Sensory integration therapy) will not be restricted. If the patients whose condition needs to be treated with drugs other than MPH, the tests must be discontinued.
- After four weeks, we will assess the short-term efficacy symptoms and cognitive function of the patients. Patients will be saked to collect saliva at 7:00-8:00 in the morning¸ after that, to analysis endocrine substance concentration. The behavioral and neurocognitive assessment will be performed using CGI-S、SNAP-IV(parent form), SNAP-IV(teacher form), CBCL, TRF and CPT.
- At week 52, we will assess the long-term efficacy of the cases the symptoms and cognitive function in the first 52 weeks. We will collect the saliva sampe of ADHD patients at 7:00-8:00 in the morning. The behavioral and neurocognitive assessment will be performed using CGI-S、SNAP-IV(parent form), SNAP-IV(teacher form), CBCL, TRF, CPT and WISC-IV. Finally, in K-SADS-E interviews to assess whether the patient is still meet the ADHD diagnostic criteria of DSM-IV-TR.
- Saliva sample will be collected into collecting tubes and stored in the refrigerator at-80°C. The salivary levels of DHEA, DHREA-S, cortisol and testosterone will be determined using ELISA kits.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Methylphenidate
- Keywords
- neuroendocrine, ADHD, heredity, cognitive 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.
MethylphenidateDrug
Also called Retalin, concerta
Patients used Retina or Concerta twice a day lasting for one year.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startAug 2013
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (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 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Liang-Jen, Chang Gung Memorial Hospital
- Investigators
- Liang-Jen Wang, MD, MPH, Principal investigator, Chang Gung Memorial Hospital, Kaohsiung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392169
- Sponsor's protocol ID
- 101-4835A3
- Status last verified
- Mar 2015
- First submitted
- 12 Mar 2015
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the Neuroendocrine Substrates, Candidate Genes and Endophenotypes in Patients With Attention-deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02392169
- Acronym / sponsor ID
- 101-4835A3
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- neuroendocrine, ADHD, heredity, cognitive function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 18 Mar 2015 (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.
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common child and adolescent psychiatric disorders. In recent years, some researchers have become interested in analyzing neuroendocrine substrate levels in ADHD, including dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEA-S), cortisol and testosterone. Previous work in ADHD has established a strong heritable component to the phenotype. The STS gene, SULT2A1 gene and TH gene are associated with the function of DHEA/DHEA-S, and the NR3C1 gene is associated with the regulation of cortisol. Therefore, the relationship between these genes and the etiology of ADHD warrants investigation. Moreover, compared to the phenotype, the endophenotypes of ADHD may be more capable of detecting the underlying neurobiological and hereditary mechanisms. Therefore, this study aims to investigate the relationships between neuroendocrine substrates (DHEA, DHEA-S, cortisol and testosterone), candidate genes (STS gene, SULT2A1 gene, TH gene and NR3C1 gene) and the phenotype and endophenotypes (disease subtypes, neurocognitive function and response to treatment) of ADHD.
To complete this work, we will recruit 300 patients with ADHD (probands) and 600 biological parents of the probands. DNA will be extracted from buccal cells by cheek swab. At baseline, saliva samples of ADHD patients will be collected between 7:00 and 8:00 am using the passive drool method, to analyze the levels of neuroendocrine substrates. The patients will undergo assessment for their clinical symptoms and neurocognitive function. Methylphenidate will then be administered to the patients and the usual practice followed. At week 4 and week 52, procedures similar to those performed at baseline will be repeated.
The results of this study may further elucidate the complexity of the pathophysiology of ADHD. We may determine whether the neuroendocrine system, which contains levels of neuroendocrine substrates and associated genes, plays a crucial role in the phenotype and endophenotypes of ADHD. The information may serve as an important reference for the direction of future study and clinical treatment for patients with ADHD.
Detailed description
- We will recruit the patients who meet the criteria for ADHD outlined in the DSM-IV. The diagnosis will be made by a child psychiatrist in a structured interview using the Kiddie Epidemiologic Version of the Schedule for Affective Disorders and Schizophrenia (K-SADS-E ).
- The variables of questionnaire from interview include the personal data as below: Age, gender, family background, the significant pressure on growth, positions and incomes of parents, and the process of mother's pregnant.
- For genotyping analysis, DNA of patients and their biological parents will be collected using cheek swab to collect oral mucosal cells, then put it in the refrigerator at-80°C. The genotyping of STS gene, SULT2A1 gene, TH gene and NR3C1 gene will be identified.
- The saliva of patients with ADHD will be collected by passive drool method at 7:00-8:00 in the morning. The saliva specimen which use to analysis endocrine substance concentration should be placed at - 80 ° C freezer as soon as possible.
- The psychiatrist or psychologist will rate patients' symptom severity of the case. The parents of the patients have to fill in the ASRS, SNAP-IV(parent form) and CBCL. The teacher of the case has to fill in the SNAP-IV(teacher form) and TRF. The patients were administered the computerized CPT in a room dedicated to the testing to minimize the variability of the test conditions.
- After the initial assessment, patients with ADHD will begin to receive methylphenidate (MPH) treatment. Patient care was left to the discretion of the psychiatrists, who were given no treatment instructions and simply encouraged to manage their patients according to usual practice. Dosage and drug form can be adjust through the height and weight of the case and his/her clinical needs. The times and frequency of track back should be reference the clinical needs, patients and their parents' willingness. During the follow-up, non-drug therapy. (e.g. Behavioral therapy, Sensory integration therapy) will not be restricted. If the patients whose condition needs to be treated with drugs other than MPH, the tests must be discontinued.
- After four weeks, we will assess the short-term efficacy symptoms and cognitive function of the patients. Patients will be saked to collect saliva at 7:00-8:00 in the morning¸ after that, to analysis endocrine substance concentration. The behavioral and neurocognitive assessment will be performed using CGI-S、SNAP-IV(parent form), SNAP-IV(teacher form), CBCL, TRF and CPT.
- At week 52, we will assess the long-term efficacy of the cases the symptoms and cognitive function in the first 52 weeks. We will collect the saliva sampe of ADHD patients at 7:00-8:00 in the morning. The behavioral and neurocognitive assessment will be performed using CGI-S、SNAP-IV(parent form), SNAP-IV(teacher form), CBCL, TRF, CPT and WISC-IV. Finally, in K-SADS-E interviews to assess whether the patient is still meet the ADHD diagnostic criteria of DSM-IV-TR.
- Saliva sample will be collected into collecting tubes and stored in the refrigerator at-80°C. The salivary levels of DHEA, DHREA-S, cortisol and testosterone will be determined using ELISA kits.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients from Kaohsiung, Taiwan by specialist clinical diagnosis of ADHD.
Key inclusion criteria (2 listed)
- Patients with ADHD aged between 6 and 16.
- The patients were either newly diagnosed with ADHD or had an existing diagnosis but had not taken medication for ADHD during the previous 6 months or more.
Key exclusion criteria (1 listed)
- Patients with a history of major physical or additional psychiatric diseases .
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: Retalin, concertaPatients used Retina or Concerta twice a day lasting for one year. | Drug | – |
Primary outcome
The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)
Time frame: 15 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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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.
Liang-Jen Wang, MD, MPH principal investigator
Chang Gung Memorial Hospital, Kaohsiung, Taiwan
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 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 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: status not confirmed, as of the sponsor's last update on 18 Mar 2015. 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 Pao-Yen Lin, MD, PhD (886-7-7317123 ext. 8751, py1029@adm.cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV) (time frame: 15 min). 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 Mar 2015.