CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 200 enrolled
Drug / intervention
Phosphatidylserine-Omega3 +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00418184
NCT00418184Phase 2Completed

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

Enzymotec·interventional·Posted Jan 4, 2007·Updated Mar 12, 2014

In Brief

A Phase 2 clinical trial evaluating Phosphatidylserine-Omega3 and Colored cellulose tainted with fishy odor for Attention Deficit/Hyperactivity Disorder (ADHD). Completed, enrolled 200 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIsrael
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 4, 2007
Enrollment StartMar 1, 2007
Primary CompletionNov 1, 2008
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.5 years ago

Interventions

Phosphatidylserine-Omega3dietary

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.

Colored cellulose tainted with fishy odorother

as arm 1