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

Sponsored by:	Enzymotec
Information provided by:	Enzymotec
ClinicalTrials.gov Identifier:	NCT00418184

Purpose

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.

Condition	Intervention	Phase
Attention Deficit/Hyperactivity Disorder (ADHD)	Dietary Supplement: Phosphatidylserine-Omega3 Other: Colored cellulose tainted with fishy odor	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Cellulose sodium phosphate Cellulose Phosphocellulose

U.S. FDA Resources

Further study details as provided by Enzymotec:

Primary Outcome Measures:

Conners Rating Scale - school version [ Time Frame: on weeks 0,5,10,15,22 & 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Conners Rating Scale - home version [ Time Frame: on weeks 0,5,10,15,22,30 and also 43,56,69,82 ] [ Designated as safety issue: No ]
Strength and difficulties questionnaires - school version [ Time Frame: on weeks 0,5,10,15,22 &30 ] [ Designated as safety issue: No ]
Strength and difficulties questionnaires - home version [ Time Frame: on weeks 0,5,10,15,22,30 and also 43,56,69,82 ] [ Designated as safety issue: No ]
Clinical Global Impression of Improvement [ Time Frame: on weeks 0,5,10,15,22,30 and also 43,56,69,82 ] [ Designated as safety issue: No ]
Test of Variables of Attention (TOVA) [ Time Frame: on weeks 0,15,30 and also 82 ] [ Designated as safety issue: No ]
Child Health questionnaire (CHQ)- Parent-completed Form 50 [ Time Frame: on weeks 0,15, 30 and also 82 ] [ Designated as safety issue: No ]
Plasma and red blood cells fatty acid profile [ Time Frame: on weeks 0,15 and 30 ] [ Designated as safety issue: Yes ]
Blood monoamines metabolism [ Time Frame: on week 0, 15 and 30. ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: on weeks 0,5,10,15,22,30 and also 43,56,69,82 ] [ Designated as safety issue: Yes ]
Essential fatty acid (EFA)-deficiency symptoms [ Time Frame: on weeks 0,5,10,15,22,30 and also 43,56,69,82 ] [ Designated as safety issue: Yes ]
Barkley Side Effects Rating Scale (SERS) [ Time Frame: on weeks 0,5,10,15,22,30 and also 43,56,69,82 ] [ Designated as safety issue: Yes ]
Complete blood counts [ Time Frame: on weeks 0,15 and 30 ] [ Designated as safety issue: Yes ]
Biochemical parameters in blood - liver functions (SGPT, SGOT, total bilirubin), kidney functions (BUN, creatinine), Na, K, Cl, Ca [ Time Frame: on weeks 0,15 and 30 ] [ Designated as safety issue: Yes ]
Lipid profile (cholesterol, HDL, triglycerides) [ Time Frame: on weeks 0,15 and 30 ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: on weeks 0,5,10,15,22,30 and also 43,56,69,82 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	March 2007
Estimated Study Completion Date:	November 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.
2: Placebo Comparator	Other: Colored cellulose tainted with fishy odor as arm 1

Detailed Description:

This study is a single-center, double-blind, randomized, placebo-controlled 30-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.

Eligibility

Ages Eligible for Study:	6 Years to 13 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Parental written informed consent.
Having a teacher that is familiar with the child and parent and willing to participate.
Age: 13≥ years ≥6
Gender: male and female
Diagnosis: ADHD diagnosed by:

Teacher-rated Attention-Deficit/ Hyperactivity Disorder Rating Scale-IV ADHD-RS-IV) School Version at least 1.5 standard deviations (SD) above the norm for the patient's age and gender, Confirmed assessment by Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL),
Clinical Global Impression of Severity of Illness (CGI-S) rating of 4 or higher (moderately ill or worse),
Language: Subjects, parents, and teachers must be able to read, write and speak Hebrew
Normal weight and height according to the Israeli standards
Attending full-time to school.

Exclusion Criteria:

Females who had reached menarche and presented three regular menstrual cycles; the definition of regular menstrual cycles: an average length of the cycle between 22 and 41 days, either none or a single cycle with a length less than 22 or more than 41 days during the past year
History or current diagnosis of any serious systemic (e.g., diabetes, hyper/hypothyroidism, etc.) or neurological condition (e.g., epilepsy, brain tumors, etc.)
Failed to respond to 2 or more adequate courses (dose and duration) of stimulant therapy for ADHD
Pervasive developmental disorder or Non-verbal Learning Disability
Schizophrenia, or other psychotic disorders (DSM-IV axis I)
Any evidence of suicidal risk, any current psychiatric comorbidity that required psychiatric pharmacotherapy
History of alcohol or substance abuse as defined by DSM-IV criteria
Consumption of >250 mg/day of caffeine
Blindness
History of allergic reactions or sensitivity to marine products (fish and seafood), soy or corn as well as any illness which may jeopardize the participants health or limit their successful trial completion.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418184

Locations

Israel
ADHD Unit
Petach-Tiqva, Israel, 49100

Sponsors and Collaborators

Enzymotec

Investigators

Study Director:

Abraham Weizman, MD

Head of the Research Department, Geha Mental Health Center, Rabin Medical Center

More Information

No publications provided

Responsible Party:	Enzymotec LTD ( Manor Yonatan )
Study ID Numbers:	PS-Omega3-2
Study First Received:	December 31, 2006
Last Updated:	December 14, 2008
ClinicalTrials.gov Identifier:	NCT00418184 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Enzymotec:

ADHD
inattentive
impulsive
hyperactive

poor academic performance
poor self-discipline
low self-esteem

Study placed in the following topic categories:

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Omega 3 Fatty Acid
Mental Disorders Diagnosed in Childhood

Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Signs and Symptoms
Pathologic Processes
Disease
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Nervous System Diseases

Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

ClinicalTrials.gov processed this record on September 10, 2009