Autism Spectrum DisorderNCT03115671
Efficacy Study of Vayarin in Children With Autism and Comorbid Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Vayarin in people with Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, run by Institute of Mental Health, Singapore at 1 site in Singapore.
Trial summary
This research study is carried out to examine the effects of Phosphatidylserine-Omega 3 supplements (i.e., Vayarin) among children with Autism Spectrum Disorder (ASD) and ADHD. Participants will be randomised either to receive the Vayarin treatment (Intervention group) or to a Control group. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder
- What is being tested?
- Vayarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- 30 Nov 2016to 31 Dec 2018
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between the age of 6 and 12 years old inclusive.
- Meets diagnostic criteria for ASD, based on Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), and/or equivalent diagnosis based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR).
- Meets diagnostic criteria for ADHD (hyperactive/inattentive/combined subtype), based on Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
- Potential participants who are on stimulatory prescriptions should have no dose change 1 month prior to study initiation and throughout the study.
- Potential participants who are on other omega supplements to stop the supplements prior to the initiation and throughout the study.
- Potential participants who are on behavioural interventions should have no change in frequency or treatment plan 1 month prior to study initiation and throughout the study.
Who cannot join
- Girls who have reached menarche and presented with 3 previous regular menstrual cycles to minimize risk of adverse side effects.
- Change in dosage of psychiatric pharmacotherapy or other medications that have central nervous system effects or that affect performance, e.g., antidepressants (e.g. SSRIs, SNRIs), antipsychotics, adrenergic blockers, decongestant or sympathomimetics, anticonvulsants, mood stabilizers, melatonin, and sedating anti-histamines, or lithium carbonate 1 month before study initiation and throughout the study phase.
- Patients that would be contraindicated for Aspirin and Warfarin treatment or present with known allergic reactions or sensitivity to marine, soy or corn products, or any other illness that the clinician determines may jeopardize patient's health.
- Patients with a known genetic syndrome which may complicate the presentation of ASD (e.g. Fragile X, William's Syndrome, Prader-Willi etc.) or presenting with suspected brain or central nervous system condition.
- Patients who present with symptoms of psychosis or high risk condition such as mood issues and suicide risk or present with history of physical, sexual or emotional abuse
- Patients who did not adhere to the study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Pilot Study on the Efficacy of Phosphatidylserine-Omega 3 (Vayarin) in Pediatric Patients Diagnosed With Autism and Comorbid Attention Deficit Hyperactivity Disorder (ADHD)
This research study is carried out to examine the effects of Phosphatidylserine-Omega 3 supplements (i.e., Vayarin) among children with Autism Spectrum Disorder (ASD) and ADHD. Participants will be randomised either to receive the Vayarin treatment (Intervention group) or to a Control group.
Read the detailed description
There has been growing interest in the role of supplements such as omega-3 polyunsaturated fatty acids (n-3 PUFAs) in ADHD and ASD. Two of the primary n-3 PUFAs are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are critical to brain development and are usually obtained through our diets. Increasing evidence has shown that children with ASD and/or ADHD have lower overall blood n-3 PUFAs levels than typically developing children (Parletta, Niyonsenga \& Duff, 2016). Therefore, many studies have been conducted to examine the effectiveness of n-3 PUFAs supplementation among these two populations. While these supplements were found to have small but reliable benefit on ADHD symptoms (Hawkey \& Nigg, 2014), there is limited evidence to support the use of n-3 PUFAs in clinical practice for the treatment of behavioural symptoms in children with ASD (James, Montgomery \& Williams, 2011; Roux, 2015). Such inconsistencies give rise to the exploration of other alternatives in administering n-3 PUFAs.
Phosphatidylserine (PS), an acidic phospholipid (PL) molecule, comprises of a glycerol backbone esterified to the hydroxyl group of the amino acid serine via a phosphate group and to two fatty acids moiety (Manor et al., 2012). It plays a key role in the functioning of neuron membranes and may enhance the bioavailability of PUFAs. Administration of PL containing omega-3 PUFAs showed greater improvement in visual sustained attention performance among school children with ADHD, as compared to placebo and fish oil groups (Vaisman et al., 2008). Similarly, another study also suggested the benefits of PS-Omega3 (i.e., Vayarin) in reducing ADHD symptoms (Manor et al., 2012). This supplementation is shown to be generally safe and well-tolerated (Manor et al., 2013).
Nevertheless, these studies were conducted among children with ADHD. Given that n-3 PUFAs are commonly used by children with comorbid ASD and ADHD, there is a need to examine whether similar effects can be observed in this population. The goal of our present study is to examine the effect of PS-Omega3 supplement among children with comorbid ASD and ADHD. The safety and tolerability will also be assessed in this pilot trial.
- Being tested
- Vayarin
- Keywords
- Phosphatidylserine, Omega-3
- Medical subject headings
- Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VayarinDietary supplement
Also called Phosphatidylserine-omega-3 (Lipirinen)
Vayarin capsule
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Each child participant in the Intervention group will be taking 4 capsules of Vayarin per day for 3 months. Each capsule contains 167mg Lipirinen, providing 75mg Phosphatidylserine (PS), 21.5mg EPA and 8.5mg DHA. This gives a daily dosage of 300mg PS and 120mg EPA/DHA. They may continue their treatment as usual provided there is no change in medication and intervention during the trial. Receives: Dietary Supplement: Vayarin |
| Control | No intervention | Participants in the Control group will not be given Vayarin. They may continue their treatment as usual provided there is no change in medication and intervention during the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conners 3rd Edition - Parent
Changes from baseline to Week 12 on Conners 3rd Edition - Parent
Measured: 12 weeks, assessed at baseline and week 12
Social Responsiveness Scale (SRS)
Changes from baseline to Week 12 on Social Responsiveness Scale (SRS)
Measured: 12 weeks, assessed at baseline and week 12
Aberrant Behaviour Checklist (ABC)
Change from baseline to Week 12 on the Aberrant Behaviour Checklist (ABC), specifically on irritability subscale
Measured: 12 weeks, assessed at baseline and week 12
Secondary outcomes (1)
Physical examination and safety evaluation (PAERS)
Assessments of related side effects and adverse events of the supplements based on physical examination and safety evaluation (as measured by PAERS) at baseline, Week 6 and 12
Measured: 12 weeks, assessed at baseline, week 6 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start30 Nov 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Mental Health, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sung Min, Institute of Mental Health, Singapore
- Investigators
- Min Sung, Dr, Principal investigator, Institute of Mental Health, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115671
- Sponsor's protocol ID
- DSRB A/16/01120
- Other IDs
- CTC 1600529
- Status last verified
- Aug 2019
- First submitted
- 12 Apr 2017
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manor I, Magen A, Keidar D, Rosen S, Tasker H, Cohen T, Richter Y, Zaaroor-Regev D, Manor Y, Weizman A. The effect of phosphatidylserine containing Omega3 fatty-acids on attention-deficit hyperactivity disorder symptoms in children: a double-blind placebo-controlled trial, followed by an open-label extension. Eur Psychiatry. 2012 Jul;27(5):335-42. doi: 10.1016/j.eurpsy.2011.05.004. Epub 2011 Jul 31.
PubMed 21807480Manor I, Magen A, Keidar D, Rosen S, Tasker H, Cohen T, Richter Y, Zaaroor-Regev D, Manor Y, Weizman A. Safety of phosphatidylserine containing omega3 fatty acids in ADHD children: a double-blind placebo-controlled trial followed by an open-label extension. Eur Psychiatry. 2013 Aug;28(6):386-91. doi: 10.1016/j.eurpsy.2012.11.001. Epub 2013 Jan 9.
PubMed 23312676Vaisman N, Kaysar N, Zaruk-Adasha Y, Pelled D, Brichon G, Zwingelstein G, Bodennec J. Correlation between changes in blood fatty acid composition and visual sustained attention performance in children with inattention: effect of dietary n-3 fatty acids containing phospholipids. Am J Clin Nutr. 2008 May;87(5):1170-80. doi: 10.1093/ajcn/87.5.1170.
PubMed 18469236
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Pilot Study on the Efficacy of Phosphatidylserine-Omega 3 (Vayarin) in Pediatric Patients Diagnosed With Autism and Comorbid Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT03115671
- Acronym / sponsor ID
- DSRB A/16/01120
- Keywords
- Phosphatidylserine, Omega-3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Institute of Mental Health, SingaporeUniversity, hospital or other
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 14 Apr 2017 (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 research study is carried out to examine the effects of Phosphatidylserine-Omega 3 supplements (i.e., Vayarin) among children with Autism Spectrum Disorder (ASD) and ADHD. Participants will be randomised either to receive the Vayarin treatment (Intervention group) or to a Control group.
Detailed description
There has been growing interest in the role of supplements such as omega-3 polyunsaturated fatty acids (n-3 PUFAs) in ADHD and ASD. Two of the primary n-3 PUFAs are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are critical to brain development and are usually obtained through our diets. Increasing evidence has shown that children with ASD and/or ADHD have lower overall blood n-3 PUFAs levels than typically developing children (Parletta, Niyonsenga \& Duff, 2016). Therefore, many studies have been conducted to examine the effectiveness of n-3 PUFAs supplementation among these two populations. While these supplements were found to have small but reliable benefit on ADHD symptoms (Hawkey \& Nigg, 2014), there is limited evidence to support the use of n-3 PUFAs in clinical practice for the treatment of behavioural symptoms in children with ASD (James, Montgomery \& Williams, 2011; Roux, 2015). Such inconsistencies give rise to the exploration of other alternatives in administering n-3 PUFAs.
Phosphatidylserine (PS), an acidic phospholipid (PL) molecule, comprises of a glycerol backbone esterified to the hydroxyl group of the amino acid serine via a phosphate group and to two fatty acids moiety (Manor et al., 2012). It plays a key role in the functioning of neuron membranes and may enhance the bioavailability of PUFAs. Administration of PL containing omega-3 PUFAs showed greater improvement in visual sustained attention performance among school children with ADHD, as compared to placebo and fish oil groups (Vaisman et al., 2008). Similarly, another study also suggested the benefits of PS-Omega3 (i.e., Vayarin) in reducing ADHD symptoms (Manor et al., 2012). This supplementation is shown to be generally safe and well-tolerated (Manor et al., 2013).
Nevertheless, these studies were conducted among children with ADHD. Given that n-3 PUFAs are commonly used by children with comorbid ASD and ADHD, there is a need to examine whether similar effects can be observed in this population. The goal of our present study is to examine the effect of PS-Omega3 supplement among children with comorbid ASD and ADHD. The safety and tolerability will also be assessed in this pilot trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: VayarinEach child participant in the Intervention group will be taking 4 capsules of Vayarin per day for 3 months. Each capsule contains 167mg Lipirinen, providing 75mg Phosphatidylserine (PS), 21.5mg EPA and 8.5mg DHA. This gives a daily dosage of 300mg PS and 120mg EPA/DHA. They may continue their treatment as usual provided there is no change in medication and intervention during the trial. |
| Control | No intervention | –Participants in the Control group will not be given Vayarin. They may continue their treatment as usual provided there is no change in medication and intervention during the trial. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Between the age of 6 and 12 years old inclusive.
- Meets diagnostic criteria for ASD, based on Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), and/or equivalent diagnosis based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR).
- Meets diagnostic criteria for ADHD (hyperactive/inattentive/combined subtype), based on Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
- Potential participants who are on stimulatory prescriptions should have no dose change 1 month prior to study initiation and throughout the study.
- Potential participants who are on other omega supplements to stop the supplements prior to the initiation and throughout the study.
Key exclusion criteria (6 listed)
- Girls who have reached menarche and presented with 3 previous regular menstrual cycles to minimize risk of adverse side effects.
- Change in dosage of psychiatric pharmacotherapy or other medications that have central nervous system effects or that affect performance, e.g., antidepressants (e.g. SSRIs, SNRIs), antipsychotics, adrenergic blockers, decongestant or sympathomimetics, anticonvulsants, mood stabilizers, melatonin, and sedating anti-histamines, or lithium carbonate 1 month before study initiation and throughout the study phase.
- Patients that would be contraindicated for Aspirin and Warfarin treatment or present with known allergic reactions or sensitivity to marine, soy or corn products, or any other illness that the clinician determines may jeopardize patient's health.
- Patients with a known genetic syndrome which may complicate the presentation of ASD (e.g. Fragile X, William's Syndrome, Prader-Willi etc.) or presenting with suspected brain or central nervous system condition.
- Patients who present with symptoms of psychosis or high risk condition such as mood issues and suicide risk or present with history of physical, sexual or emotional abuse
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 |
|---|---|---|
| VayarinAlso: Phosphatidylserine-omega-3 (Lipirinen)Vayarin capsule | Dietary supplement | Intervention |
Primary outcome
Conners 3rd Edition - Parent
Time frame: 12 weeks, assessed at baseline and week 12
Changes from baseline to Week 12 on Conners 3rd Edition - Parent
Social Responsiveness Scale (SRS)
Time frame: 12 weeks, assessed at baseline and week 12
Changes from baseline to Week 12 on Social Responsiveness Scale (SRS)
Aberrant Behaviour Checklist (ABC)
Time frame: 12 weeks, assessed at baseline and week 12
Change from baseline to Week 12 on the Aberrant Behaviour Checklist (ABC), specifically on irritability subscale
1 secondary outcome
Physical examination and safety evaluation (PAERS)
Time frame: 12 weeks, assessed at baseline, week 6 and week 12
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 14 Aug 2019.
- Background: PubMed 21807480Manor I, Magen A, Keidar D, Rosen S, Tasker H, Cohen T, Richter Y, Zaaroor-Regev D, Manor Y, Weizman A. The effect of phosphatidylserine containing Omega3 fatty-acids on attention-deficit hyperactivity disorder symptoms in children: a double-blind placebo-controlled trial, followed by an open-label extension. Eur Psychiatry. 2012 Jul;27(5):335-42. doi: 10.1016/j.eurpsy.2011.05.004. Epub 2011 Jul 31.
- Background: PubMed 23312676Manor I, Magen A, Keidar D, Rosen S, Tasker H, Cohen T, Richter Y, Zaaroor-Regev D, Manor Y, Weizman A. Safety of phosphatidylserine containing omega3 fatty acids in ADHD children: a double-blind placebo-controlled trial followed by an open-label extension. Eur Psychiatry. 2013 Aug;28(6):386-91. doi: 10.1016/j.eurpsy.2012.11.001. Epub 2013 Jan 9.
- Background: PubMed 18469236Vaisman N, Kaysar N, Zaruk-Adasha Y, Pelled D, Brichon G, Zwingelstein G, Bodennec J. Correlation between changes in blood fatty acid composition and visual sustained attention performance in children with inattention: effect of dietary n-3 fatty acids containing phospholipids. Am J Clin Nutr. 2008 May;87(5):1170-80. doi: 10.1093/ajcn/87.5.1170.
- 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.
Min Sung, Dr principal investigator
Institute of Mental Health, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vayarin in people with Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, run by Institute of Mental Health, Singapore at 1 site in Singapore.
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 6 inclusion and 6 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Conners 3rd Edition - Parent (time frame: 12 weeks, assessed at baseline and week 12). 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?
On the ClinicalTrials.gov record for NCT03115671, which also lists 3 linked publications.
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 14 Aug 2019.