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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03749824
• Other study ID #: YNC-SASSI-Quanti-2
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: August 2015

Study information

• Verified date: November 2018
• Source: Yale-NUS College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• Attention Deficit and Disruptive Behavior Disorders
• Conduct Disorder
• Disease
• Oppositional Defiant Disorder

Intervention

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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yale-NUS College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Heart Rate at 6 months	For Trier Social Stress Task	7 minutes each at 0 months and 6 months
Primary	Change from Baseline Skin Conductance Response at 6 months	For loud sound	4 minutes each at 0 months and 6 months
Primary	Change from Baseline Skin Conductance Response at 6 months	For threatening photographs	4 minutes each at 0 months and 6 months