Attention Deficit Hyperactivity Disorder (ADHD)NCT02074176
Plasma Orexin A and mRNA Expression Levels of Pre-pro-orexin Gene in Attention-Deficit Hyperactivity Disorder
An observational study of Attention Deficit Hyperactivity Disorder (ADHD), run by National Taiwan University Hospital.
Trial summary
Background: Attention deficit hyperactivity disorder (ADHD) is an early onset, highly heritable, clinically heterogeneous, long-term impairing disorder with tremendous impact on individuals, families, and societies. It affects 7.5% of school-aged children in Taiwan. 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 (ADHD)
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2011
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Subjects in this study will be recruited from Children's Mental Health Center, Department of Psychiatry, National Taiwan University Hospital (NTUH). The sample will consist of 50 ADHD probands and 50 age- and sex- matched controls.
Who may be able to join
- For the proband subjects to be eligible to participate in this study, they need to fit the following criteria: (1) subjects have a clinical diagnosis of ADHD, or Hyperkinetic Disorder defined by the DSM-IV and ICD-10, respectively, which was made by a full-time board-certificated child psychiatrist at the first visit and following visits; (2) their ages range from 6 to 18 when we conduct the study; (3) subjects have at least one biological parent; and (4) both parents are Han Chinese.
Who cannot join
- The proband subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective Disorder, Organic Psychosis, or Pervasive Developmental Disorder. Moreover, the subjects will also be excluded from the study if they completely cannot cooperate with blood withdrawal.
About this study
Background: Attention deficit hyperactivity disorder (ADHD) is an early onset, highly heritable, clinically heterogeneous, long-term impairing disorder with tremendous impact on individuals, families, and societies. It affects 7.5% of school-aged children in Taiwan. Emerging evidence has suggested that patients with ADHD may present with a deficit of attention, alertness and sleep disturbances. Since attention, alertness, and sleep disturbances may significantly increase the functional impairment of ADHD, gaining insight into their pathophysiology as well as into their treatment is of relevance to provide a better clinical management of patients suffering from ADHD. The orexin system, located in the hypothalamus, takes an important role in homeostatic functions, such as attention, alertness, sleep-wake cycle, and feeding. To our best knowledge, the functioning of the orexin system has never been investigated in patients with ADHD. Given the involvement of the orexin system in the control of alertness and reward seeking, the present study aims to examine whether plasma orexin and mRNA expression levels of pre-pro-orexin gene are associated with the symptoms and neurocognitive deficits of ADHD.
Read the detailed description
Specific Aims:
- To evaluate the correlations between plasma levels of orexin A and symptoms of ADHD.
- To evaluate the correlations between mRNA expression levels of pre-pro-orexin gene and symptoms of ADHD.
- To evaluate the correlations between plasma levels of orexin A and neurocognitive dysfunction of ADHD.
- To evaluate the correlations between mRNA expression levels of pre-pro-orexin gene and neurocognitive dysfunction of ADHD.
Subjects and Methods: Subjects in this study will be recruited from Children's Mental Health Center, Department of Psychiatry, National Taiwan University Hospital (NTUH). The sample will consist of 50 ADHD probands (aged 6 to 18 years) and 50 age- and sex- matched healthy controls. The phenotype measures include (1) interviews for psychopathology (K-SADS-E) and social functioning (SAICA), (2) self-administered questionnaires to measures ADHD symptoms (SNAP-IV), comorbid conditions (YSR, CBCL), and family support (Family APGAR), and (3) Neuropsychological tests: CPT, WISC-III, and CANTAB. Plasma orexin A and mRNA expression levels of pre-pro-orexin gene will be measured in all participants.
Anticipated Results: We anticipate the identification of potential relationship between plasma orexin A, mRNA expression and symptoms of ADHD. In addition, this study will determine the association of plasma orexin A and mRNA expression with the neurocognitive deficits of ADHD. We hope that this study will elucidate the pathogenesis of ADHD, and orexin A will be a possible biomarker for this disorder. In addition, the data of orexin A and mRNA expression of pre-pro-orexin gene in ADHD will provide insight in developing more specific and more effective treatment for ADHD.
- Keywords
- Attention-deficit/hyperactivity disorder, orexin A, mRNA
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
SNAP-IV
self-administered questionnaires to measures ADHD symptoms
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startJan 2011
- Primary completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi-Yung Shang, Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074176
- Sponsor's protocol ID
- 201008049R
- Status last verified
- Feb 2014
- First submitted
- 26 Feb 2014
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Orexin A and mRNA Expression Levels of Pre-pro-orexin Gene in Attention-Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02074176
- Acronym / sponsor ID
- 201008049R
- Keywords
- Attention-deficit/hyperactivity disorder, orexin A, mRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- First posted
- 28 Feb 2014 (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.
Background: Attention deficit hyperactivity disorder (ADHD) is an early onset, highly heritable, clinically heterogeneous, long-term impairing disorder with tremendous impact on individuals, families, and societies. It affects 7.5% of school-aged children in Taiwan. Emerging evidence has suggested that patients with ADHD may present with a deficit of attention, alertness and sleep disturbances. Since attention, alertness, and sleep disturbances may significantly increase the functional impairment of ADHD, gaining insight into their pathophysiology as well as into their treatment is of relevance to provide a better clinical management of patients suffering from ADHD. The orexin system, located in the hypothalamus, takes an important role in homeostatic functions, such as attention, alertness, sleep-wake cycle, and feeding. To our best knowledge, the functioning of the orexin system has never been investigated in patients with ADHD. Given the involvement of the orexin system in the control of alertness and reward seeking, the present study aims to examine whether plasma orexin and mRNA expression levels of pre-pro-orexin gene are associated with the symptoms and neurocognitive deficits of ADHD.
Detailed description
Specific Aims:
- To evaluate the correlations between plasma levels of orexin A and symptoms of ADHD.
- To evaluate the correlations between mRNA expression levels of pre-pro-orexin gene and symptoms of ADHD.
- To evaluate the correlations between plasma levels of orexin A and neurocognitive dysfunction of ADHD.
- To evaluate the correlations between mRNA expression levels of pre-pro-orexin gene and neurocognitive dysfunction of ADHD.
Subjects and Methods: Subjects in this study will be recruited from Children's Mental Health Center, Department of Psychiatry, National Taiwan University Hospital (NTUH). The sample will consist of 50 ADHD probands (aged 6 to 18 years) and 50 age- and sex- matched healthy controls. The phenotype measures include (1) interviews for psychopathology (K-SADS-E) and social functioning (SAICA), (2) self-administered questionnaires to measures ADHD symptoms (SNAP-IV), comorbid conditions (YSR, CBCL), and family support (Family APGAR), and (3) Neuropsychological tests: CPT, WISC-III, and CANTAB. Plasma orexin A and mRNA expression levels of pre-pro-orexin gene will be measured in all participants.
Anticipated Results: We anticipate the identification of potential relationship between plasma orexin A, mRNA expression and symptoms of ADHD. In addition, this study will determine the association of plasma orexin A and mRNA expression with the neurocognitive deficits of ADHD. We hope that this study will elucidate the pathogenesis of ADHD, and orexin A will be a possible biomarker for this disorder. In addition, the data of orexin A and mRNA expression of pre-pro-orexin gene in ADHD will provide insight in developing more specific and more effective treatment for ADHD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects in this study will be recruited from Children's Mental Health Center, Department of Psychiatry, National Taiwan University Hospital (NTUH). The sample will consist of 50 ADHD probands and 50 age- and sex- matched controls.
Key inclusion criteria (1 listed)
- For the proband subjects to be eligible to participate in this study, they need to fit the following criteria: (1) subjects have a clinical diagnosis of ADHD, or Hyperkinetic Disorder defined by the DSM-IV and ICD-10, respectively, which was made by a full-time board-certificated child psychiatrist at the first visit and following visits; (2) their ages range from 6 to 18 when we conduct the study; (3) subjects have at least one biological parent; and (4) both parents are Han Chinese.
Key exclusion criteria (1 listed)
- The proband subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective Disorder, Organic Psychosis, or Pervasive Developmental Disorder. Moreover, the subjects will also be excluded from the study if they completely cannot cooperate with blood withdrawal.
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
SNAP-IV
Time frame: baseline
self-administered questionnaires to measures ADHD symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
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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, Ph.D. principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder (ADHD), run by National Taiwan University Hospital.
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: status not confirmed, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
SNAP-IV (time frame: baseline). 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 28 Feb 2014; AzTrials last refreshed its copy on 7 Nov 2026.