Who is sponsoring NCT00418184?

NCT00418184 is sponsored by Enzymotec.

What condition does NCT00418184 study?

NCT00418184 studies Attention Deficit/Hyperactivity Disorder (ADHD).

What drugs are being tested in NCT00418184?

Interventions: Phosphatidylserine-Omega3, Colored cellulose tainted with fishy odor.

What is the status of NCT00418184?

NCT00418184 is currently COMPLETED.

Last reviewed 2014-02-12 · How we verify

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

NCT00418184 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Enzymotec
Phase	Phase 2
Status	COMPLETED
Enrolment	200
Start date	2007-03
Completion	2009-11

Conditions

Attention Deficit/Hyperactivity Disorder (ADHD)

Interventions

Phosphatidylserine-Omega3
Colored cellulose tainted with fishy odor

Primary outcomes

Conners Rating Scale - School Version — change from baseline in conners raiting scale at 15 weeks
A questionnaire that assesses symptoms of ADHD in children and adolescents according to the DSM-IV guidelines. It consists of questions on classroom behavior. Based on the questionnaire results, subscales and global indexes are calculated, including restless-impulsive index, emotional lability index and hyperactive/impulsive subscale. The lowest scale score is 40 (best)and the highest is 90 (worse). Usually, a score below 62 is considered normal and a score above 62 is considered abnormal.

Countries

Israel