Vayarin® Plus has been studied in a multi-center, double-blind, placebo controlled, randomized clinical study with 180 adults with ADHD.
CLINICAL STUDY RESULTS
IMPROVES GLOBAL ADHD BEHAVIORS AND INATTENTION
Vayarin® Plus was clinically shown to improve global ADHD behaviors, as well as inattention in ADHD patients
MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, SEQUENTIAL PARALLEL COMPARISON DESIGN (SPCD) TRIAL (8 wks) N=189; AGED 18-60 ADMINISTERED EQUIVALENT OF 2 CAPSULES VAYARIN® PLUS (450 mg) PER DAY
IMPROVED BRIEF-A TASK MONITORING
Reflects the ability to keep track of one’s problem-solving success or failure and identify and correct mistakes.
Vayarin® Plus was clinically shown to improve task monitoring behaviors in ADHD patients
CLINICAL STUDY DESIGN
The Vayarin® Plus study design was chosen to minimize placebo response commonly observed in studies of various neurological conditions.
STUDY DESIGN (SPCD* MODEL)
VAYARIN® PLUS WAS SUCCESFUL IN SHOWING IMPROVEMENT IN GLOBAL ADHD BEHAVIORS IN THE TOTAL POPULATION VS PLACEBO
*sequential parallel comparison design
VAYARIN® PLUS WAS SHOWN TO BE SAFE & WELL TOLERATED WITH A SIDE EFFECT PROFILE EQUIVALENT TO PLACEBO
Vayarin® Plus should be taken by adults & adolescents over the age of 14, who weigh above 97lbs/44kgs.
*Adverse events reported during the two phases of the clinical trial (total of sixteen weeks), which were judged by the study physicians as related or possible related to the study treatment
**Numbers are based on total numbers of patients who received placebo or Vayarin® Plus at some point during the trial
Our patented PS-Omega-3 structure was tested in a preclinical study and shown to be superior in increasing the bioavailability of Omega-3 in brain tissue compared to control and common Omega-3 products: fish oil, phosphatidylserine (soy-PS), and soy-PS added to fish oil.
IN ANIMAL MODEL, PS-OMEGA-3 SIGNIFICANTLY INCREASED BIOAVAILABILITY TO THE BRAIN
Significant increase of 42% in Omega-3 bioavailability in the brain versus control
*p<0.05 compared to control, based on one-way ANOVA
Vaisman N, et al., Prog Neuropsychopharmacol Bio Psychiatry 2009;33:952-959.