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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
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.
as arm 1
ADHD Unit
Petach-Tiqva, Israel
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.
Time frame: change from baseline in conners raiting scale at 15 weeks
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.
Time frame: change from baseline in conners raiting scale at 15 weeks
Strength and Difficulties Questionnaires - School Version
Time frame: on weeks 0,15
Strength and Difficulties Questionnaires - Home Version
Time frame: on weeks 0,15
Clinical Global Impression of Improvement
Time frame: on weeks 0,15
Test of Variables of Attention (TOVA)
Time frame: on weeks 0,15
Child Health Questionnaire (CHQ)- Parent-completed Form 50
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Time frame: on weeks 0,15
Plasma and Red Blood Cells Fatty Acid Profile
Time frame: on weeks 0,15
Blood Monoamines Metabolism
Time frame: on week 0, 15
Vital Signs
Time frame: on weeks 0,15
Essential Fatty Acid (EFA)-Deficiency Symptoms
Time frame: on weeks 0,15
Barkley Side Effects Rating Scale (SERS)
Time frame: on weeks 0,15
Complete Blood Counts
Time frame: on weeks 0,15
Biochemical Parameters in Blood - Liver Functions (SGPT, SGOT, Total Bilirubin), Kidney Functions (BUN, Creatinine), Na, K, Cl, Ca
Time frame: on weeks 0,15
Lipid Profile (Cholesterol, HDL, Triglycerides)
Time frame: on weeks 0,15