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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03749824
Enrollment
133
Registered
2018-11-21
Start date
2011-08-31
Completion date
2015-08-31
Last updated
2018-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD, Conduct Disorder, Oppositional Defiant Disorder

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.

Interventions

DIETARY_SUPPLEMENTOmega-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.

DIETARY_SUPPLEMENTPlacebo 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.

Sponsors

Yale-NUS College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Heart Rate at 6 months7 minutes each at 0 months and 6 monthsFor Trier Social Stress Task
Change from Baseline Skin Conductance Response at 6 months4 minutes each at 0 months and 6 monthsFor loud sound

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026