Attention-deficit/Hyperactivity DisorderNCT03299647
Effects of Polyunsaturated Fatty Acids on the Visual Memory of 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 investigators anticipate to identify specific polyunsaturated fatty acids that show significant differences between ADHD and control groups. In addition, these findings may offer more biological understanding in explaining the relationship between polyunsaturated fatty acids and visual memory among children with… 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
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Jul 2017to 30 Jul 2018
- 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: The researchers plan to recruit 35 ADHD subjects and 35 control subjects.
Who may be able to join
- 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.
Who cannot join
- 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 Univeristy Hospital
Taipei
Chi-Yung Shang, MD
About this study
The investigators anticipate to identify specific polyunsaturated fatty acids that show significant differences between ADHD and control groups. In addition, these findings may offer more biological understanding in explaining the relationship between polyunsaturated fatty acids and visual memory among children with ADHD. The results will significantly contribute to the knowledge of the pathophysiological mechanisms of ADHD, especially the polyunsaturated fatty acids related to the behavioral/visual memory deficits of ADHD.
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 the investigators' previous work, children with ADHD have visual memory deficits as well as inattentive deficits. Previous studies show that polyunsaturated fatty acids are associated with cognitive problems in children. Analyzing differences in polyunsaturated fatty acids between children with ADHD and healthy controls could provide insight into underlying disease pathology of cognitive deficits. In this one-year project, the researchers will perform an analysis of polyunsaturated fatty acids in serum to identify potential biomarkers for the visual memory deficits of ADHD.
The purpose of this study is to:
- To identify the specific polyunsaturated fatty acids of ADHD symptoms;
- To identify the relationship between specific polyunsaturated fatty acids and visual memory deficits of ADHD.
This is a one-year project. After careful calculation of sample size, the study will recruit 35 children with ADHD, aged 7-18, and 35 healthy controls with matched age, sex and BMI. The investigators will quantify the polyunsaturated fatty acids in serum. The behavioral measures include ADHDRS-IV, SNAP-IV, CBCL, CGI-ADHD-S, SAICA, and Family APGAR-C. The Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used to assess the visual memory of all participants. Conditional logistic regression and partial least squares discriminant analysis will be applied to identify significant polyunsaturated fatty acids for ADHD and visual memory deficits.
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Keywords
- Attention-deficit/hyperactivity disorder, behavioral deficits, cognitive function, polyunsaturated fatty acids, visual memory
- 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 (3)
Continuous Performance Test (CPT)
The main feature of CPT is that a rapid presentation of visual or auditory stimuli over a definite period of time. The subjects respond by pressing a switch button in response to a critical stimulus.
Measured: 15 minutes
Wechsler Intelligence Scale for Children-3rd edition (WISC-III)
The WISC-III is composed of 13 subtests to test children's cognitive ability of different dimensions, which are grouped into two scores: performance IQ score (7 subtests: Picture Completion, Block Design, Object Assembly, Picture Arrangement, Coding, Symbol Search and Mazes subtests) and verbal IQ score (Information, Comprehension, Arithmetic, Similarities, Digit Span and Vocabulary subtests) (Allen and Thorndike 1995).
Measured: 1.5 hours
Cambridge Neuropsychological Test Automated Batteries (CANTAB)
The CANTAB is a computer-administered, nonverbal (visually-presented) set of neuropsychological tasks developed at the University of Cambridge.
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 posted3 Oct 2017
- Study start31 Jul 2017
- Primary completion30 Jul 2018 (estimated)
- Study completion30 Jul 2018 (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
- 70 participants (estimated)
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
- NCT03299647
- Sponsor's protocol ID
- 201705134RINC
- Status last verified
- Sep 2017
- First submitted
- 25 Sep 2017
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Polyunsaturated Fatty Acids on the Visual Memory of Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03299647
- Acronym / sponsor ID
- 201705134RINC
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Keywords
- Attention-deficit/hyperactivity disorder, behavioral deficits, cognitive function, polyunsaturated fatty acids, visual memory
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 30 Jul 2018 (estimated)
- First posted
- 3 Oct 2017 (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 investigators anticipate to identify specific polyunsaturated fatty acids that show significant differences between ADHD and control groups. In addition, these findings may offer more biological understanding in explaining the relationship between polyunsaturated fatty acids and visual memory among children with ADHD. The results will significantly contribute to the knowledge of the pathophysiological mechanisms of ADHD, especially the polyunsaturated fatty acids related to the behavioral/visual memory deficits of ADHD.
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 the investigators' previous work, children with ADHD have visual memory deficits as well as inattentive deficits. Previous studies show that polyunsaturated fatty acids are associated with cognitive problems in children. Analyzing differences in polyunsaturated fatty acids between children with ADHD and healthy controls could provide insight into underlying disease pathology of cognitive deficits. In this one-year project, the researchers will perform an analysis of polyunsaturated fatty acids in serum to identify potential biomarkers for the visual memory deficits of ADHD.
The purpose of this study is to:
- To identify the specific polyunsaturated fatty acids of ADHD symptoms;
- To identify the relationship between specific polyunsaturated fatty acids and visual memory deficits of ADHD.
This is a one-year project. After careful calculation of sample size, the study will recruit 35 children with ADHD, aged 7-18, and 35 healthy controls with matched age, sex and BMI. The investigators will quantify the polyunsaturated fatty acids in serum. The behavioral measures include ADHDRS-IV, SNAP-IV, CBCL, CGI-ADHD-S, SAICA, and Family APGAR-C. The Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used to assess the visual memory of all participants. Conditional logistic regression and partial least squares discriminant analysis will be applied to identify significant polyunsaturated fatty acids for ADHD and visual memory deficits.
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
- The researchers plan to recruit 35 ADHD subjects and 35 control subjects.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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)
3 secondary outcomes
Continuous Performance Test (CPT)
Time frame: 15 minutes
Wechsler Intelligence Scale for Children-3rd edition (WISC-III)
Time frame: 1.5 hours
Cambridge Neuropsychological Test Automated Batteries (CANTAB)
Time frame: 1.5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- 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 8 inclusion and 7 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 13 Oct 2017. 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, MD (886-2-23123456 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?
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 13 Oct 2017.