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Investigation of Psychophysiological Response to Aversive Stimuli Over Time With Omega-3

Primary Purpose

Conduct Disorder, ADHD, Oppositional Defiant Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Omega-3
Placebo Capsules
Sponsored by
Yale-NUS College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Conduct Disorder

Eligibility Criteria

7 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects between ages 7 and 16 years
  2. Subjects who fulfil all criteria for a DSM-IV diagnosis of ADHD, conduct disorder, or oppositional defiant disorder
  3. Subjects with willingness to participate in a randomized, double-blind controlled trial
  4. Subjects with complete written, informed parental consent and child assent
  5. Subjects with IQ of 70 or more

Exclusion Criteria:

  1. Subjects who have IQ in the below 70
  2. Subjects who are younger than 7 years old or older than 16 years old
  3. Those without written parental consent
  4. Those with brain pathology such as serious head injury, epilepsy, etc.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Omega-3

    Placebo Capsules

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Change from Baseline Heart Rate at 6 months
    For Trier Social Stress Task
    Change from Baseline Skin Conductance Response at 6 months
    For loud sound
    Change from Baseline Skin Conductance Response at 6 months
    For threatening photographs

    Secondary Outcome Measures

    Full Information

    First Posted
    October 29, 2018
    Last Updated
    November 20, 2018
    Sponsor
    Yale-NUS College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03749824
    Brief Title
    Investigation of Psychophysiological Response to Aversive Stimuli Over Time With Omega-3
    Official Title
    Investigation of Psychophysiological Response to Aversive Stimuli Over Time With Omega-3
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (Actual)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yale-NUS College

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Conduct Disorder, ADHD, Oppositional Defiant Disorder

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    133 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Omega-3
    Arm Type
    Experimental
    Arm 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 Title
    Placebo Capsules
    Arm Type
    Placebo Comparator
    Arm 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(s)
    Omega-3
    Intervention 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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo Capsules
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Change from Baseline Heart Rate at 6 months
    Description
    For Trier Social Stress Task
    Time Frame
    7 minutes each at 0 months and 6 months
    Title
    Change from Baseline Skin Conductance Response at 6 months
    Description
    For loud sound
    Time Frame
    4 minutes each at 0 months and 6 months
    Title
    Change from Baseline Skin Conductance Response at 6 months
    Description
    For threatening photographs
    Time Frame
    4 minutes each at 0 months and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects between ages 7 and 16 years Subjects who fulfil all criteria for a DSM-IV diagnosis of ADHD, conduct disorder, or oppositional defiant disorder Subjects with willingness to participate in a randomized, double-blind controlled trial Subjects with complete written, informed parental consent and child assent Subjects with IQ of 70 or more Exclusion Criteria: Subjects who have IQ in the below 70 Subjects who are younger than 7 years old or older than 16 years old Those without written parental consent Those with brain pathology such as serious head injury, epilepsy, etc.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel Fung
    Organizational Affiliation
    Institute of Mental Health, Singapore
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Investigation of Psychophysiological Response to Aversive Stimuli Over Time With Omega-3

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