NCT00418184

The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Enzymotec · Industry
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial is to determine whether an oral administration of Phosphatidylserine-Omega3 would significantly improve the clinical symptoms of children suffering from ADHD. Both the behavior and the academic achievements aspects will be evaluated. In addition, we intend to measure side-effects and adverse events and to examine the possible correlation between biochemical and behavioral alterations.

Detailed description

This study is a single-center, double-blind, randomized, placebo-controlled 15-weeks duration trial to assess safety and efficacy of Phosphatidylserine-Omega3 in children diagnosed with ADHD, according to the DSM-IV. Following screening, the subjects will be randomized to one of two treatment groups:Phosphatidylserine-Omega3 or placebo, in a 2:1 manner. This will be followed by an open-label extension, in which Phosphatidylserine-Omega3 will be administered to all eligible participants. Primary measures of attention and behavior will be evaluated using Conners Rating Scale (CRS) teacher- rating scales. As a secondary endpoint, the attention and behavior will be measured by CRS and strength and difficulties questionnaires (SDQ) parental- and SDQ teacher-rating scales, assessment a continuous performance test (TOVA), and parental Child Health questionnaire (CHQ). Improvement in ADHD symptoms will be evaluated by Clinical Global of Impression - Improvement (CGI-I). Finally, tolerability will be monitored using Barkley Side Effects Rating Scale (SERS) and biochemical parameters, such as fatty acid profile and monoamines metabolites will be assessed as well.

Conditions

• Attention Deficit/Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Phosphatidylserine-Omega3	Phosphatidylserine-Omega3 conjugate capsules. Weeks 0-15: 300 mg/day. weeks 16-30: 150 mg/day and a 150 mg/day one year follow-up.
OTHER	Colored cellulose tainted with fishy odor	as arm 1

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-11-01
• Completion: 2009-11-01
• First posted: 2007-01-04
• Last updated: 2014-03-12
• Results posted: 2010-02-26

Locations

1 site across 1 country: Israel