MedTrace Logo

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

NCT00418184 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-03-12

Study results available
· View outcomes & findings →

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.

Conditions

  • Attention Deficit/Hyperactivity Disorder (ADHD)

Interventions

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

Sponsors & Collaborators

  • Enzymotec

    lead INDUSTRY

Principal Investigators

  • Abraham Weizman, MD · Head of the Research Department, Geha Mental Health Center, Rabin Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-11-30
Completion
2009-11-30

Countries

  • Israel

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00418184 on ClinicalTrials.gov