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

Not Applicable

Completed

• Conditions: Conduct Disorder; ADHD; Oppositional Defiant Disorder
• Interventions: Dietary Supplement: Placebo Capsules; Dietary Supplement: Omega-3

• Registration Number: NCT03749824
• Lead Sponsor: Yale-NUS College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2018-10-29
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-20
• Last Update Submitted: 2018-11-20
• Study First Posted: 2018-11-21
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Capsules	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.
Omega-3	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Heart Rate at 6 months	7 minutes each at 0 months and 6 months	For Trier Social Stress Task
Change from Baseline Skin Conductance Response at 6 months	4 minutes each at 0 months and 6 months	For threatening photographs