NCT03115671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

2.1 years

First QC Date

April 12, 2017

Last Update Submit

August 13, 2019

Conditions

Autism Spectrum DisorderAttention Deficit Hyperactivity Disorder

Keywords

PhosphatidylserineOmega-3

Outcome Measures

Primary Outcomes (3)

  • Conners 3rd Edition - Parent

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

    12 weeks, assessed at baseline and week 12

  • Social Responsiveness Scale (SRS)

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

    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

    12 weeks, assessed at baseline and week 12

Secondary Outcomes (1)

  • Physical examination and safety evaluation (PAERS)

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

Study Arms (2)

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.

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.

Interventions

VayarinDIETARY_SUPPLEMENT

Vayarin capsule

Also known as: Phosphatidylserine-omega-3 (Lipirinen)
Intervention

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Guidance Clinic

Singapore, 168937, Singapore

Location

Related Publications (3)

  • 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.

    PMID: 21807480BACKGROUND

  • 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.

    PMID: 23312676BACKGROUND

  • 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.

    PMID: 18469236BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderAttention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersAttention Deficit and Disruptive Behavior Disorders

Study Officials

  • Min Sung, Dr

    Institute of Mental Health, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Clinicians conducting the study assessments and teachers who will be providing feedback will be blinded to the study arm.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant, Psychiatrist

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 14, 2017

Study Start

November 30, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

August 14, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)