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

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.

Study Overview

• Status: Completed
• Conditions: ADHD; Conduct Disorder; Oppositional Defiant Disorder
• Intervention / Treatment: Dietary supplement: Omega-3; Dietary supplement: Placebo Capsules

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Omega-3; 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; 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.
PLACEBO_COMPARATOR: Placebo Capsules; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale-NUS College

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2011
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (ACTUAL): November 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 21, 2018
• Last Update Submitted That Met QC Criteria: November 20, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurodevelopmental Disorders; Disease; Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders
• Other Study ID Numbers: YNC-SASSI-Quanti-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No