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

NCT03749824 | Completed

• 1 other identifier: YNC-SASSI-Quanti-2
• Study Type: interventional
• Target: 133
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Conduct Disorder; ADHD; Oppositional Defiant Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Omega-3

EXPERIMENTAL

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

Placebo Capsules

PLACEBO COMPARATOR

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

Interventions

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.

Omega-3

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.

Placebo Capsules

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale-NUS College: lead

MeSH Terms

Conditions

Conduct Disorder; Attention Deficit Disorder with Hyperactivity; Oppositional Defiant Disorder

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Daniel Fung

  Institute of Mental Health, Singapore

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 21, 2018
• Study Start: August 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 21, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share