Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418184
Status:
COMPLETED
Last Update Posted:
2014-03-12
First Post:
2006-12-31
Brief Title:
The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit Hyperactivity Disorder
Sponsor:
Enzymotec
Organization:
Enzymotec
Study Overview
Official Title:
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
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 groupsPhosphatidylserine-Omega3 or placebo in a 21 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None