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

• ClinicalTrials.gov Identifier: NCT03749824
• Recruitment Status: Completed
• First Posted: November 21, 2018
• Last Update Posted: November 21, 2018
• Sponsor: Yale-NUS College
• Information provided by (Responsible Party): Jean Liu, Yale-NUS College

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Conduct Disorder; ADHD; Oppositional Defiant Disorder	Dietary Supplement: Omega-3; Dietary Supplement: Placebo Capsules	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 133 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Investigation of Psychophysiological Response to Aversive Stimuli Over Time With Omega-3
• Actual Study Start Date: August 2011
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: August 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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 Comparator: 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.	Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline Heart Rate at 6 months [ Time Frame: 7 minutes each at 0 months and 6 months ]
   For Trier Social Stress Task
2. Change from Baseline Skin Conductance Response at 6 months [ Time Frame: 4 minutes each at 0 months and 6 months ]
   For loud sound
3. Change from Baseline Skin Conductance Response at 6 months [ Time Frame: 4 minutes each at 0 months and 6 months ]
   For threatening photographs

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 16 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

Yale-NUS College

Investigators

• Study Director: Daniel Fung; Institute of Mental Health, Singapore

More Information

• Responsible Party: Jean Liu, Assistant Professor, Yale-NUS College
• ClinicalTrials.gov Identifier: NCT03749824
• Other Study ID Numbers: YNC-SASSI-Quanti-2
• First Posted: November 21, 2018
• Last Update Posted: November 21, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Disease; Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders; Pathologic Processes; Neurodevelopmental Disorders; Mental Disorders