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

Yale-NUS College

Status: Completed

Conditions: Oppositional Defiant Disorder; Conduct Disorder; ADHD

Treatments: Dietary Supplement: Placebo Capsules; Dietary Supplement: Omega-3

Study type: Interventional

Funder types: Other

Identifiers

NCT03749824

YNC-SASSI-Quanti-2

Details and patient eligibility

About

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.

Enrollment: 133 patients

Sex: All

Ages: 7 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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133 participants in 2 patient groups, including a placebo group

Omega-3

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Omega-3

Placebo Capsules

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo Capsules