An interventional study of Omega-3 and Placebo Capsules in Conduct Disorder, ADHD and Oppositional Defiant Disorder, sponsored by Yale-NUS College. Completed. Open to participants aged 7 Years to 16 Years. Per ClinicalTrials.gov, last updated 2018-11-21.
Sponsored by Yale-NUS College · Not applicable, Interventional, and Health services research
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.
101 studies on the registry are indexed under Conduct Disorder; 15 are open to participants now.
This study's enrollment of 133 is close to the median of 124 across 80 interventional studies indexed under Conduct Disorder.
Browse Conduct Disorder studies →Yale-NUS College is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Change from Baseline Heart Rate at 6 months
For Trier Social Stress Task
Time frame: 7 minutes each at 0 months and 6 months
Change from Baseline Skin Conductance Response at 6 months
For loud sound
Time frame: 4 minutes each at 0 months and 6 months
Change from Baseline Skin Conductance Response at 6 months
For threatening photographs
Time frame: 4 minutes each at 0 months and 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2011 to primary completion in Aug 2015, 48 months.
Of 29 interventional studies with no phase under Conduct Disorder, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 68. This study's 48 months is above that.
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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omega-3 fatty acid
Yale-NUS College