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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder

Conditions
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Attention Deficit/Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Dietary Supplement: Phosphatidylserine-Omega3
* Other: Colored cellulose tainted with fishy odor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Dietary Supplement: Phosphatidylserine-Omega3<br>* 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.<br>|
| Placebo Comparator: 2<br> | Other: Colored cellulose tainted with fishy odor<br>* as arm 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 
| Child Health Questionnaire (CHQ)- Parent-completed Form 50 |  | on weeks 0,15 | 
| Plasma and Red Blood Cells Fatty Acid Profile |  | on weeks 0,15 | 
| Blood Monoamines Metabolism |  | on week 0, 15 | 
| Vital Signs |  | on weeks 0,15 | 
| Essential Fatty Acid (EFA)-Deficiency Symptoms |  | on weeks 0,15 | 
| Barkley Side Effects Rating Scale (SERS) |  | on weeks 0,15 | 
| Complete Blood Counts |  | on weeks 0,15 | 
| Biochemical Parameters in Blood - Liver Functions (SGPT, SGOT, Total Bilirubin), Kidney Functions (BUN, Creatinine), Na, K, Cl, Ca |  | on weeks 0,15 | 
| Lipid Profile (Cholesterol, HDL, Triglycerides) |  | on weeks 0,15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, inattentive, impulsive, hyperactive, poor academic performance, poor self-discipline, low self-esteem