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.

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Key information

Conditions

Conduct Disorder ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders Oppositional Defiant Disorder

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega-3

Dietary Supplement

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 capsules

Dietary Supplement

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 outcomes

Change from Baseline Heart Rate at 6 months

Time frame: 7 minutes each at 0 months and 6 months

For Trier Social Stress Task
Change from Baseline Skin Conductance Response at 6 months

Time frame: 4 minutes each at 0 months and 6 months

For loud sound
Change from Baseline Skin Conductance Response at 6 months

Time frame: 4 minutes each at 0 months and 6 months

For threatening photographs

Sponsors and collaborators

Lead sponsor

Yale-NUS College

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Nov 21, 2018
Registry last updated: Nov 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed