<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03299647</url>
  </required_header>
  <id_info>
    <org_study_id>201705134RINC</org_study_id>
    <nct_id>NCT03299647</nct_id>
  </id_info>
  <brief_title>Effects of Polyunsaturated Fatty Acids on the Visual Memory of Children With Attention Deficit Hyperactivity Disorder</brief_title>
  <official_title>Effects of Polyunsaturated Fatty Acids on the Visual Memory of Children With Attention Deficit Hyperactivity Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators anticipate to identify specific polyunsaturated fatty acids that show&#xD;
      significant differences between ADHD and control groups. In addition, these findings may&#xD;
      offer more biological understanding in explaining the relationship between polyunsaturated&#xD;
      fatty acids and visual memory among children with ADHD. The results will significantly&#xD;
      contribute to the knowledge of the pathophysiological mechanisms of ADHD, especially the&#xD;
      polyunsaturated fatty acids related to the behavioral/visual memory deficits of ADHD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Because attention deficit hyperactivity disorder (ADHD) is an early onset and long-term&#xD;
      impairing disorder with tremendous impact on individuals, families, and societies, detection&#xD;
      and diagnosis are very important for ADHD. According to the investigators' previous work,&#xD;
      children with ADHD have visual memory deficits as well as inattentive deficits. Previous&#xD;
      studies show that polyunsaturated fatty acids are associated with cognitive problems in&#xD;
      children. Analyzing differences in polyunsaturated fatty acids between children with ADHD and&#xD;
      healthy controls could provide insight into underlying disease pathology of cognitive&#xD;
      deficits. In this one-year project, the researchers will perform an analysis of&#xD;
      polyunsaturated fatty acids in serum to identify potential biomarkers for the visual memory&#xD;
      deficits of ADHD.&#xD;
&#xD;
      The purpose of this study is to:&#xD;
&#xD;
        1. To identify the specific polyunsaturated fatty acids of ADHD symptoms;&#xD;
&#xD;
        2. To identify the relationship between specific polyunsaturated fatty acids and visual&#xD;
           memory deficits of ADHD.&#xD;
&#xD;
      This is a one-year project. After careful calculation of sample size, the study will recruit&#xD;
      35 children with ADHD, aged 7-18, and 35 healthy controls with matched age, sex and BMI. The&#xD;
      investigators will quantify the polyunsaturated fatty acids in serum. The behavioral measures&#xD;
      include ADHDRS-IV, SNAP-IV, CBCL, CGI-ADHD-S, SAICA, and Family APGAR-C. The Cambridge&#xD;
      Neuropsychological Test Automated Battery (CANTAB) will be used to assess the visual memory&#xD;
      of all participants. Conditional logistic regression and partial least squares discriminant&#xD;
      analysis will be applied to identify significant polyunsaturated fatty acids for ADHD and&#xD;
      visual memory deficits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Anticipated">July 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Psychiatric interview</measure>
    <time_frame>1 hour</time_frame>
    <description>Subjects will be interviewed by Chinese Version of the Kiddie Epidemiologic version of the Schedule for Affective Disorders and Schizophrenia (K-SADS-E)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Continuous Performance Test (CPT)</measure>
    <time_frame>15 minutes</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wechsler Intelligence Scale for Children-3rd edition (WISC-III)</measure>
    <time_frame>1.5 hours</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cambridge Neuropsychological Test Automated Batteries (CANTAB)</measure>
    <time_frame>1.5 hours</time_frame>
    <description>The CANTAB is a computer-administered, nonverbal (visually-presented) set of neuropsychological tasks developed at the University of Cambridge.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Attention-deficit/Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>ADHD group</arm_group_label>
    <description>Subjects with clinical diagnosis of ADHD according to the DSM-V criteria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TD group</arm_group_label>
    <description>Typically development controls without lifetime diagnosis with ADHD</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The biospecimen includes plasma and DNA of the participants.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The researchers plan to recruit 35 ADHD subjects and 35 control subjects.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with ADHD are eligible to be included in this study only if they meet all of the&#xD;
        following criteria:&#xD;
&#xD;
          1. Patients will be outpatients who are between 7 and 18 years of age.&#xD;
&#xD;
          2. Patients must have ADHD that meet the Diagnostic and Statistical Manual of Mental&#xD;
             disorders, 5th edition (DSM-V) disease diagnostic criteria assessed by the&#xD;
             investigator's clinical evaluation, as well as confirmed by the Chinese version of the&#xD;
             Schedule for Affective Disorders and Schizophrenia for School-Age&#xD;
             Children-Epidemiological Version (K-SADS-E).&#xD;
&#xD;
          3. Patients must have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score &gt; 4&#xD;
             at baseline.&#xD;
&#xD;
          4. Patients must be psychotropic drug-naïve. Patients will be considered to be drug-naïve&#xD;
             if they have never received medications specifically to treat ADHD.&#xD;
&#xD;
          5. Patients and parents (or legal representative) must have a degree of understanding&#xD;
             sufficient to be able to communicate suitably with the investigator.&#xD;
&#xD;
          6. Patients must be of normal intelligence in the judgment of the investigator. Normal&#xD;
             intelligence is defined as achieving a score of 80 or more when IQ testing is&#xD;
             administrated.&#xD;
&#xD;
          7. Patients must have been judged by the investigator to be reliable to keep appointments&#xD;
             for clinic visits and all tests, including neuropsychological testing and&#xD;
             venipunctures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded from the study if they meet any of the following criteria:&#xD;
&#xD;
          1. Patients with current or past history of schizophrenia, schizoaffective Disorder,&#xD;
             organic psychosis, bipolar I or II disorder, autism, or autism spectrum disorder.&#xD;
             Other comorbid psychiatric disorders are not excluded if the ADHD symptoms are the&#xD;
             primary source of impairment for the patient.&#xD;
&#xD;
          2. Patients with a history of any seizure disorder (other than febrile convulsion) or&#xD;
             patients who are taking anticonvulsants for seizure control.&#xD;
&#xD;
          3. Patients have been at serious suicidal risk, determined by the investigator.&#xD;
&#xD;
          4. Patients with a history of alcohol or drug abuse within the past 3 months, or who are&#xD;
             currently using alcohol, drugs of abuse, or any described or over-the-counter&#xD;
             medication in a manner that the investigator considers indicative of abuse.&#xD;
&#xD;
          5. Patients with cardiovascular disease or other conditions that could be aggravated by&#xD;
             an increased heart rate or increased blood pressure.&#xD;
&#xD;
          6. Patients who are likely to need Chinese medicine or health-food supplements that have&#xD;
             central nervous system activity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chi-Yung Shang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept of Psychiatry, National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chi-Yung Shang, MD</last_name>
    <phone>886-2-23123456 Ext. 66965</phone>
    <email>cyshang@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan Univeristy Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chi-Yung Shang, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>October 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Attention-deficit/hyperactivity disorder</keyword>
  <keyword>behavioral deficits</keyword>
  <keyword>cognitive function</keyword>
  <keyword>polyunsaturated fatty acids</keyword>
  <keyword>visual memory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03299647
org study id: 201705134RINC
nct id: NCT03299647
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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:

        1. To identify the specific polyunsaturated fatty acids of ADHD symptoms;

        2. 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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Psychiatric interview
time frame: 1 hour
description: Subjects will be interviewed by Chinese Version of the Kiddie Epidemiologic version of the Schedule for Affective Disorders and Schizophrenia (K-SADS-E)
measure: Continuous Performance Test (CPT)
time frame: 15 minutes
description: 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.
measure: Wechsler Intelligence Scale for Children-3rd edition (WISC-III)
time frame: 1.5 hours
description: 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).
measure: Cambridge Neuropsychological Test Automated Batteries (CANTAB)
time frame: 1.5 hours
description: The CANTAB is a computer-administered, nonverbal (visually-presented) set of neuropsychological tasks developed at the University of Cambridge.
arm group label: ADHD group
description: Subjects with clinical diagnosis of ADHD according to the DSM-V criteria
arm group label: TD group
description: Typically development controls without lifetime diagnosis with ADHD
The biospecimen includes plasma and DNA of the participants.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chi-Yung Shang, MD
role: Principal Investigator
affiliation: Dept of Psychiatry, National Taiwan University Hospital
last name: Chi-Yung Shang, MD
phone: 886-2-23123456 Ext. 66965
email: cyshang@ntu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity
sharing ipd: No