<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/NCT03749824</url>
  </required_header>
  <id_info>
    <org_study_id>YNC-SASSI-Quanti-2</org_study_id>
    <nct_id>NCT03749824</nct_id>
  </id_info>
  <brief_title>Investigation of Psychophysiological Response to Aversive Stimuli Over Time With Omega-3</brief_title>
  <official_title>Investigation of Psychophysiological Response to Aversive Stimuli Over Time With Omega-3</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale-NUS College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale-NUS College</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the psychophysiological responses to aversive stimuli in a population&#xD;
      of 133 children clinically diagnosed with conduct disorder (CD) and/or&#xD;
      attention-deficit/hyperactivity disorder (ADHD). Participants were administered with either&#xD;
      omega-3 or placebo for a period of 6 months and were exposed to three stimuli every three&#xD;
      months: 1) a loud sound, 2) threatening photographs from the International Affective Picture&#xD;
      System (IAPS), and 3) the Trier Social Stress Task (TSST). Participants' psychophysiological&#xD;
      features of heart rate and galvanic skin conductance were measured and analyzed in relation&#xD;
      to their omega-3/placebo condition clinical diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2011</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Heart Rate at 6 months</measure>
    <time_frame>7 minutes each at 0 months and 6 months</time_frame>
    <description>For Trier Social Stress Task</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Skin Conductance Response at 6 months</measure>
    <time_frame>4 minutes each at 0 months and 6 months</time_frame>
    <description>For loud sound</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Skin Conductance Response at 6 months</measure>
    <time_frame>4 minutes each at 0 months and 6 months</time_frame>
    <description>For threatening photographs</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>Conduct Disorder</condition>
  <condition>ADHD</condition>
  <condition>Oppositional Defiant Disorder</condition>
  <arm_group>
    <arm_group_label>Omega-3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children in this group will be given 400 mg of DHA and 600 mg of EPA. Caregivers will be instructed to give two 500mg Omega-3 capsules twice a day, at breakfast and at the evening meal for 6 months. Parents will be seen by the attending on a monthly basis for standard treatment procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Capsules</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Children in this group will be given two placebo capsules twice daily; at breakfast and at the evening meal for a total period of 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Omega-3</intervention_name>
    <description>Omega-3 supplement is a highly concentrated fish oil brain booster supplement that helps compensate for the neurocognitive and brain dysfunction which acts as a predisposition to antisocial and violent behaviour. Individuals with antisocial personality disorder have been found to show an 11% reduction in gray matter in the prefrontal cortex (Raine et al. 2001), and structural prefrontal impairments are hypothesised to result in disinhibition of limbic subcortical structures that give rise to aggressive behaviour. Omega-3 (specifically DHA) is known to play a key role in neuronal structure and function.</description>
    <arm_group_label>Omega-3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo Capsules</intervention_name>
    <description>Children in this group will be given two placebo capsules twice daily; at breakfast and at the evening meal for a total period of 6 months.</description>
    <arm_group_label>Placebo Capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects between ages 7 and 16 years&#xD;
&#xD;
          2. Subjects who fulfil all criteria for a DSM-IV diagnosis of ADHD, conduct disorder, or&#xD;
             oppositional defiant disorder&#xD;
&#xD;
          3. Subjects with willingness to participate in a randomized, double-blind controlled&#xD;
             trial&#xD;
&#xD;
          4. Subjects with complete written, informed parental consent and child assent&#xD;
&#xD;
          5. Subjects with IQ of 70 or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who have IQ in the below 70&#xD;
&#xD;
          2. Subjects who are younger than 7 years old or older than 16 years old&#xD;
&#xD;
          3. Those without written parental consent&#xD;
&#xD;
          4. Those with brain pathology such as serious head injury, epilepsy, etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Fung</last_name>
    <role>Study Director</role>
    <affiliation>Institute of Mental Health, Singapore</affiliation>
  </overall_official>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yale-NUS College</investigator_affiliation>
    <investigator_full_name>Jean Liu</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Conduct Disorder</mesh_term>
    <mesh_term>Attention Deficit and Disruptive Behavior Disorders</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/NCT03749824
org study id: YNC-SASSI-Quanti-2
nct id: NCT03749824
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study investigates the psychophysiological responses to aversive stimuli in a population
      of 133 children clinically diagnosed with conduct disorder (CD) and/or
      attention-deficit/hyperactivity disorder (ADHD). Participants were administered with either
      omega-3 or placebo for a period of 6 months and were exposed to three stimuli every three
      months: 1) a loud sound, 2) threatening photographs from the International Affective Picture
      System (IAPS), and 3) the Trier Social Stress Task (TSST). Participants' psychophysiological
      features of heart rate and galvanic skin conductance were measured and analyzed in relation
      to their omega-3/placebo condition clinical diagnosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Change from Baseline Heart Rate at 6 months
time frame: 7 minutes each at 0 months and 6 months
description: For Trier Social Stress Task
measure: Change from Baseline Skin Conductance Response at 6 months
time frame: 4 minutes each at 0 months and 6 months
description: For loud sound
measure: Change from Baseline Skin Conductance Response at 6 months
time frame: 4 minutes each at 0 months and 6 months
description: For threatening photographs
arm group label: Omega-3
arm group type: Experimental
description: Children in this group will be given 400 mg of DHA and 600 mg of EPA. Caregivers will be instructed to give two 500mg Omega-3 capsules twice a day, at breakfast and at the evening meal for 6 months. Parents will be seen by the attending on a monthly basis for standard treatment procedure.
arm group label: Placebo Capsules
arm group type: Placebo Comparator
description: Children in this group will be given two placebo capsules twice daily; at breakfast and at the evening meal for a total period of 6 months.
intervention type: Dietary Supplement
intervention name: Omega-3
description: Omega-3 supplement is a highly concentrated fish oil brain booster supplement that helps compensate for the neurocognitive and brain dysfunction which acts as a predisposition to antisocial and violent behaviour. Individuals with antisocial personality disorder have been found to show an 11% reduction in gray matter in the prefrontal cortex (Raine et al. 2001), and structural prefrontal impairments are hypothesised to result in disinhibition of limbic subcortical structures that give rise to aggressive behaviour. Omega-3 (specifically DHA) is known to play a key role in neuronal structure and function.
arm group label: Omega-3
intervention type: Dietary Supplement
intervention name: Placebo Capsules
description: Children in this group will be given two placebo capsules twice daily; at breakfast and at the evening meal for a total period of 6 months.
arm group label: Placebo Capsules
criteria: 
gender: All
minimum age: 7 Years
maximum age: 16 Years
healthy volunteers: No
last name: Daniel Fung
role: Study Director
affiliation: Institute of Mental Health, Singapore
responsible party type: Principal Investigator
investigator affiliation: Yale-NUS College
investigator full name: Jean Liu
investigator title: Assistant Professor
mesh term: Conduct Disorder
mesh term: Attention Deficit and Disruptive Behavior Disorders
sharing ipd: No