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

Study Overview
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Brief Summary
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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.

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

Conditions
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Conduct Disorder, ADHD, Oppositional Defiant Disorder

Intervention / Treatment
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* Dietary Supplement: Omega-3
* Dietary Supplement: Placebo Capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3<br>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. | Dietary Supplement: Omega-3<br>* 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.<br>|
| Placebo Comparator: Placebo Capsules<br>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. | Dietary Supplement: Placebo Capsules<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Heart Rate at 6 months | For Trier Social Stress Task | 7 minutes each at 0 months and 6 months | 
| Change from Baseline Skin Conductance Response at 6 months | For loud sound | 4 minutes each at 0 months and 6 months | 
| Change from Baseline Skin Conductance Response at 6 months | For threatening photographs | 4 minutes each at 0 months and 6 months |