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
About this trial
This is an interventional health services research trial for Conduct Disorder
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.
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
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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