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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03115671
• Date of registration: 12/04/2017
• Prospective Registration: No
• Primary sponsor: Institute of Mental Health, Singapore
• Public title: Efficacy Study of Vayarin in Children With Autism and Comorbid Attention Deficit Hyperactivity Disorder (ADHD)
• Scientific 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)
• Date of first enrolment: November 30, 2016
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03115671
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Singapore

Contacts

• Name: Min Sung, Dr
• Affiliation: Institute of Mental Health, Singapore

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: 12 Years
Gender: All

Health Condition(s) or Problem(s) studied

Attention Deficit Hyperactivity Disorder

Autism Spectrum Disorder

Intervention(s)

Dietary Supplement: Vayarin

Primary Outcome(s)

Conners 3rd Edition - Parent [Time Frame: 12 weeks, assessed at baseline and week 12]

Social Responsiveness Scale (SRS) [Time Frame: 12 weeks, assessed at baseline and week 12]

Aberrant Behaviour Checklist (ABC) [Time Frame: 12 weeks, assessed at baseline and week 12]

Secondary Outcome(s)

Physical examination and safety evaluation (PAERS) [Time Frame: 12 weeks, assessed at baseline, week 6 and week 12]

Secondary ID(s)

DSRB A/16/01120

CTC 1600529

Source(s) of Monetary Support

Please refer to primary and secondary sponsors