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

Primary Purpose

Attention Deficit/Hyperactivity Disorder (ADHD)

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Phosphatidylserine-Omega3

Colored cellulose tainted with fishy odor

About this trial

This is an interventional treatment trial for Attention Deficit/Hyperactivity Disorder (ADHD) focused on measuring ADHD, inattentive, impulsive, hyperactive, poor academic performance, poor self-discipline, low self-esteem

Eligibility Criteria

6 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

ADHD Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Conners Rating Scale - School Version

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.

Secondary Outcome Measures

Conners Rating Scale - Home Version

A questionnaire that assesses symptoms of ADHD in children and adolescents according to the DSM-IV guidelines. It consists of questions on the childs home 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.

Strength and Difficulties Questionnaires - School Version

Strength and Difficulties Questionnaires - Home Version

Clinical Global Impression of Improvement

Test of Variables of Attention (TOVA)

Child Health Questionnaire (CHQ)- Parent-completed Form 50

Plasma and Red Blood Cells Fatty Acid Profile

Blood Monoamines Metabolism

Vital Signs

Essential Fatty Acid (EFA)-Deficiency Symptoms

Barkley Side Effects Rating Scale (SERS)

Complete Blood Counts

Biochemical Parameters in Blood - Liver Functions (SGPT, SGOT, Total Bilirubin), Kidney Functions (BUN, Creatinine), Na, K, Cl, Ca

Lipid Profile (Cholesterol, HDL, Triglycerides)

Full Information

NCT ID

NCT00418184

First Posted

December 31, 2006

Last Updated

February 12, 2014

Sponsor

Enzymotec

1. Study Identification

Unique Protocol Identification Number

NCT00418184

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Enzymotec

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit/Hyperactivity Disorder (ADHD)

Keywords

ADHD, inattentive, impulsive, hyperactive, poor academic performance, poor self-discipline, low self-esteem

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Phosphatidylserine-Omega3

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Colored cellulose tainted with fishy odor

Intervention Description

as arm 1

Primary Outcome Measure Information:

Title

Conners Rating Scale - School Version

Description

Time Frame

change from baseline in conners raiting scale at 15 weeks

Secondary Outcome Measure Information:

Title

Conners Rating Scale - Home Version

Description

Time Frame

change from baseline in conners raiting scale at 15 weeks

Title

Strength and Difficulties Questionnaires - School Version

Time Frame

on weeks 0,15

Title

Strength and Difficulties Questionnaires - Home Version

Time Frame

on weeks 0,15

Title

Clinical Global Impression of Improvement

Time Frame

on weeks 0,15

Title

Test of Variables of Attention (TOVA)

Time Frame

on weeks 0,15

Title

Child Health Questionnaire (CHQ)- Parent-completed Form 50

Time Frame

on weeks 0,15

Title

Plasma and Red Blood Cells Fatty Acid Profile

Time Frame

on weeks 0,15

Title

Blood Monoamines Metabolism

Time Frame

on week 0, 15

Title

Vital Signs

Time Frame

on weeks 0,15

Title

Essential Fatty Acid (EFA)-Deficiency Symptoms

Time Frame

on weeks 0,15

Title

Barkley Side Effects Rating Scale (SERS)

Time Frame

on weeks 0,15

Title

Complete Blood Counts

Time Frame

on weeks 0,15

Title

Biochemical Parameters in Blood - Liver Functions (SGPT, SGOT, Total Bilirubin), Kidney Functions (BUN, Creatinine), Na, K, Cl, Ca

Time Frame

on weeks 0,15

Title

Lipid Profile (Cholesterol, HDL, Triglycerides)

Time Frame

on weeks 0,15

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abraham Weizman, MD

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

ADHD Unit

City

Petach-Tiqva

ZIP/Postal Code

49100

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

21807480

Citation

Manor I, Magen A, Keidar D, Rosen S, Tasker H, Cohen T, Richter Y, Zaaroor-Regev D, Manor Y, Weizman A. The effect of phosphatidylserine containing Omega3 fatty-acids on attention-deficit hyperactivity disorder symptoms in children: a double-blind placebo-controlled trial, followed by an open-label extension. Eur Psychiatry. 2012 Jul;27(5):335-42. doi: 10.1016/j.eurpsy.2011.05.004. Epub 2011 Jul 31.

Results Reference

derived

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

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