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Efficacy Study of Vayarin in Children With Autism and Comorbid Attention Deficit Hyperactivity Disorder (ADHD)

Primary Purpose

Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Vayarin

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Phosphatidylserine, Omega-3

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Child Guidance Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Conners 3rd Edition - Parent

Changes from baseline to Week 12 on Conners 3rd Edition - Parent

Social Responsiveness Scale (SRS)

Changes from baseline to Week 12 on Social Responsiveness Scale (SRS)

Aberrant Behaviour Checklist (ABC)

Change from baseline to Week 12 on the Aberrant Behaviour Checklist (ABC), specifically on irritability subscale

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03115671

First Posted

April 12, 2017

Last Updated

August 13, 2019

Sponsor

Institute of Mental Health, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT03115671

Brief Title

Efficacy Study of Vayarin in Children With Autism and Comorbid Attention Deficit Hyperactivity Disorder (ADHD)

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

November 30, 2016 (Actual)

Primary Completion Date

December 31, 2018 (Actual)

Study Completion Date

December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institute of Mental Health, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder

Keywords

Phosphatidylserine, Omega-3

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Clinicians conducting the study assessments and teachers who will be providing feedback will be blinded to the study arm.

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Vayarin

Other Intervention Name(s)

Phosphatidylserine-omega-3 (Lipirinen)

Intervention Description

Vayarin capsule

Primary Outcome Measure Information:

Title

Conners 3rd Edition - Parent

Description

Changes from baseline to Week 12 on Conners 3rd Edition - Parent

Time Frame

12 weeks, assessed at baseline and week 12

Title

Social Responsiveness Scale (SRS)

Description

Changes from baseline to Week 12 on Social Responsiveness Scale (SRS)

Time Frame

12 weeks, assessed at baseline and week 12

Title

Aberrant Behaviour Checklist (ABC)

Description

Change from baseline to Week 12 on the Aberrant Behaviour Checklist (ABC), specifically on irritability subscale

Time Frame

12 weeks, assessed at baseline and week 12

Secondary Outcome Measure Information:

Title

Physical examination and safety evaluation (PAERS)

Description

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

Time Frame

12 weeks, assessed at baseline, week 6 and week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Min Sung, Dr

Organizational Affiliation

Institute of Mental Health, Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

Child Guidance Clinic

City

Singapore

ZIP/Postal Code

168937

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21807480

Citation

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.

Results Reference

background

PubMed Identifier

23312676

Citation

Manor 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.

Results Reference

background

PubMed Identifier

18469236

Citation

Vaisman 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.

Results Reference

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Efficacy Study of Vayarin in Children With Autism and Comorbid Attention Deficit Hyperactivity Disorder (ADHD)

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