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

This study has been completed.
Sponsor:
Information provided by:
Enzymotec
ClinicalTrials.gov Identifier:
NCT00418184
First received: December 31, 2006
Last updated: February 12, 2014
Last verified: January 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


Further study details as provided by Enzymotec:

Primary Outcome Measures:
  • Conners Rating Scale - School Version [ Time Frame: change from baseline in conners raiting scale at 15 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: change from baseline in conners raiting scale at 15 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: on weeks 0,15 ] [ Designated as safety issue: No ]
  • Strength and Difficulties Questionnaires - Home Version [ Time Frame: on weeks 0,15 ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Improvement [ Time Frame: on weeks 0,15 ] [ Designated as safety issue: No ]
  • Test of Variables of Attention (TOVA) [ Time Frame: on weeks 0,15 ] [ Designated as safety issue: No ]
  • Child Health Questionnaire (CHQ)- Parent-completed Form 50 [ Time Frame: on weeks 0,15 ] [ Designated as safety issue: No ]
  • Plasma and Red Blood Cells Fatty Acid Profile [ Time Frame: on weeks 0,15 ] [ Designated as safety issue: Yes ]
  • Blood Monoamines Metabolism [ Time Frame: on week 0, 15 ] [ Designated as safety issue: Yes ]
  • Vital Signs [ Time Frame: on weeks 0,15 ] [ Designated as safety issue: Yes ]
  • Essential Fatty Acid (EFA)-Deficiency Symptoms [ Time Frame: on weeks 0,15 ] [ Designated as safety issue: Yes ]
  • Barkley Side Effects Rating Scale (SERS) [ Time Frame: on weeks 0,15 ] [ Designated as safety issue: Yes ]
  • Complete Blood Counts [ Time Frame: on weeks 0,15 ] [ 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 ] [ Designated as safety issue: Yes ]
  • Lipid Profile (Cholesterol, HDL, Triglycerides) [ Time Frame: on weeks 0,15 ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: March 2007
Study Completion Date: November 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Placebo Comparator: 2 Other: Colored cellulose tainted with fishy odor
as arm 1

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.

  Eligibility

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

Inclusion Criteria:

  1. Parental written informed consent.
  2. Having a teacher that is familiar with the child and parent and willing to participate.
  3. Age: 13≥ years ≥6
  4. Gender: male and female
  5. 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),

  6. Clinical Global Impression of Severity of illness (CGI-S) rating of 4 or higher (moderately ill or worse),
  7. Language: Subjects, parents, and teachers must be able to read, write and speak Hebrew
  8. Normal weight and height according to the Israeli standards
  9. Attending full-time to school.

Exclusion Criteria:

  1. 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
  2. History or current diagnosis of any serious systemic (e.g., diabetes, hyper/hypothyroidism, etc.) or neurological condition (e.g., epilepsy, brain tumors, etc.)
  3. Failed to respond to 2 or more adequate courses (dose and duration) of stimulant therapy for ADHD
  4. Pervasive developmental disorder or Non-verbal Learning Disability
  5. Schizophrenia, or other psychotic disorders (DSM-IV axis I)
  6. Any evidence of suicidal risk, any current psychiatric comorbidity that required psychiatric pharmacotherapy
  7. History of alcohol or substance abuse as defined by DSM-IV criteria
  8. Consumption of >250 mg/day of caffeine
  9. Blindness
  10. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Enzymotec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Manor Yonatan, Enzymotec LTD
ClinicalTrials.gov Identifier: NCT00418184     History of Changes
Other Study ID Numbers: PS-Omega3-2
Study First Received: December 31, 2006
Results First Received: November 30, 2009
Last Updated: February 12, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Enzymotec:
ADHD
inattentive
impulsive
hyperactive
poor academic performance
poor self-discipline
low self-esteem

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Disease
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on October 16, 2014