NCT00418184

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
4 months until next milestone

Results Posted

Study results publicly available

February 26, 2010

Completed
Last Updated

March 12, 2014

Status Verified

January 1, 2010

Enrollment Period

1.7 years

First QC Date

December 31, 2006

Results QC Date

November 30, 2009

Last Update Submit

February 12, 2014

Conditions

Attention Deficit/Hyperactivity Disorder (ADHD)

Keywords

ADHDinattentiveimpulsivehyperactivepoor academic performancepoor self-disciplinelow self-esteem

Outcome Measures

Primary Outcomes (1)

  • 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.

    change from baseline in conners raiting scale at 15 weeks

Secondary Outcomes (14)

  • Conners Rating Scale - Home Version

    change from baseline in conners raiting scale at 15 weeks

  • Strength and Difficulties Questionnaires - School Version

    on weeks 0,15

  • Strength and Difficulties Questionnaires - Home Version

    on weeks 0,15

  • Clinical Global Impression of Improvement

    on weeks 0,15

  • Test of Variables of Attention (TOVA)

    on weeks 0,15

  • +9 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Dietary Supplement: Phosphatidylserine-Omega3

2

PLACEBO COMPARATOR
Other: Colored cellulose tainted with fishy odor

Interventions

Phosphatidylserine-Omega3DIETARY_SUPPLEMENT

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.

1
Colored cellulose tainted with fishy odorOTHER

as arm 1

2

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ADHD Unit

Petach-Tiqva, 49100, Israel

Location

Related Publications (1)

  • 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.

    PMID: 21807480DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityImpulsive BehaviorSpasm

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBehaviorNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Yael Richter Ph.D
Organization
Enzymotec Ltd
Yaelr@enzymotec.com
+972 74 7177 177

Study Officials

  • Abraham Weizman, MD

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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 31, 2006

First Posted

January 4, 2007

Study Start

March 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2009

Last Updated

March 12, 2014

Results First Posted

February 26, 2010

Record last verified: 2010-01

Locations

IL(1)