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

Last updated: August 13, 2019
Sponsor: Institute of Mental Health, Singapore
Overall Status: Completed

Phase

N/A

Condition

Asperger's Disorder

Autism Spectrum Disorder (Asd)

Autism

Treatment

N/A

Clinical Study ID

NCT03115671
DSRB A/16/01120
CTC 1600529
  • Ages 6-12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Between the age of 6 and 12 years old inclusive.

  • Meets diagnostic criteria for ASD, based on Diagnostic and Statistical Manual ofMental Disorders, 5th Edition (DSM-5), and/or equivalent diagnosis based on Diagnosticand Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR).

  • Meets diagnostic criteria for ADHD (hyperactive/inattentive/combined subtype), basedon 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 supplementsprior to the initiation and throughout the study.

  • Potential participants who are on behavioural interventions should have no change infrequency or treatment plan 1 month prior to study initiation and throughout thestudy.

Exclusion

Exclusion Criteria:

  • Girls who have reached menarche and presented with 3 previous regular menstrual cyclesto minimize risk of adverse side effects.

  • Change in dosage of psychiatric pharmacotherapy or other medications that have centralnervous 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 lithiumcarbonate 1 month before study initiation and throughout the study phase.

  • Patients that would be contraindicated for Aspirin and Warfarin treatment or presentwith known allergic reactions or sensitivity to marine, soy or corn products, or anyother 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 suspectedbrain or central nervous system condition.

  • Patients who present with symptoms of psychosis or high risk condition such as moodissues and suicide risk or present with history of physical, sexual or emotional abuse

  • Patients who did not adhere to the study procedures

Study Design

Total Participants: 24
Study Start date:
November 30, 2016
Estimated Completion Date:
December 31, 2018

Study 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.

Connect with a study center

  • Child Guidance Clinic

    Singapore, 168937
    Singapore

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.