Conduct DisorderNCT03749824
Investigation of Psychophysiological Response to Aversive Stimuli Over Time With Omega-3
A study testing Omega-3 in people with Conduct Disorder and ADHD, run by Yale-NUS College.
Trial 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). Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Conduct Disorder, ADHD, Oppositional Defiant Disorder
- What is being tested?
- Omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects between ages 7 and 16 years
- Subjects who fulfil all criteria for a DSM-IV diagnosis of ADHD, conduct disorder, or oppositional defiant disorder
- Subjects with willingness to participate in a randomized, double-blind controlled trial
- Subjects with complete written, informed parental consent and child assent
- Subjects with IQ of 70 or more
Who cannot join
- Subjects who have IQ in the below 70
- Subjects who are younger than 7 years old or older than 16 years old
- Those without written parental consent
- Those with brain pathology such as serious head injury, epilepsy, etc.
About this study
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.
- Conditions
- Conduct Disorder, ADHD, Oppositional Defiant Disorder
- Being tested
- Omega-3, Placebo Capsules
- Medical subject headings
- Conduct Disorder, Attention Deficit Disorder with Hyperactivity, Oppositional Defiant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
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 CapsulesDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Experimental | 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. Receives: Dietary Supplement: Omega-3 |
| Placebo Capsules | Placebo comparator | 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. Receives: Dietary Supplement: Placebo Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Heart Rate at 6 months
For Trier Social Stress Task
Measured: 7 minutes each at 0 months and 6 months
Change from Baseline Skin Conductance Response at 6 months
For loud sound
Measured: 4 minutes each at 0 months and 6 months
Change from Baseline Skin Conductance Response at 6 months
For threatening photographs
Measured: 4 minutes each at 0 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study startAug 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conduct DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale-NUS College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Liu, Yale-NUS College
- Investigators
- Daniel Fung, Study director, Institute of Mental Health, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749824
- Sponsor's protocol ID
- YNC-SASSI-Quanti-2
- Status last verified
- Nov 2018
- First submitted
- 29 Oct 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Psychophysiological Response to Aversive Stimuli Over Time With Omega-3
- ClinicalTrials.gov ID
- NCT03749824
- Acronym / sponsor ID
- YNC-SASSI-Quanti-2
- Conditions
- Conduct Disorder, ADHD, Oppositional Defiant Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Yale-NUS CollegeUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Experimental | Dietary Supplement: Omega-3Children 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. |
| Placebo Capsules | Placebo comparator | Dietary Supplement: Placebo CapsulesChildren 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. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects between ages 7 and 16 years
- Subjects who fulfil all criteria for a DSM-IV diagnosis of ADHD, conduct disorder, or oppositional defiant disorder
- Subjects with willingness to participate in a randomized, double-blind controlled trial
- Subjects with complete written, informed parental consent and child assent
- Subjects with IQ of 70 or more
Key exclusion criteria (4 listed)
- Subjects who have IQ in the below 70
- Subjects who are younger than 7 years old or older than 16 years old
- Those without written parental consent
- Those with brain pathology such as serious head injury, epilepsy, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3Omega-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 supplement | Omega-3 |
| Placebo CapsulesChildren 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 |
Primary outcome
Change from Baseline Heart Rate at 6 months
Time frame: 7 minutes each at 0 months and 6 months
For Trier Social Stress Task
Change from Baseline Skin Conductance Response at 6 months
Time frame: 4 minutes each at 0 months and 6 months
For loud sound
Change from Baseline Skin Conductance Response at 6 months
Time frame: 4 minutes each at 0 months and 6 months
For threatening photographs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Fung study director
Institute of Mental Health, Singapore
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 in people with Conduct Disorder and ADHD, run by Yale-NUS College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Heart Rate at 6 months (time frame: 7 minutes each at 0 months and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.