The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder
- Conditions
- Attention Deficit/Hyperactivity Disorder (ADHD)
- Interventions
- Dietary Supplement: Phosphatidylserine-Omega3Other: Colored cellulose tainted with fishy odor
- Registration Number
- NCT00418184
- Lead Sponsor
- Enzymotec
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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Parental written informed consent.
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Having a teacher that is familiar with the child and parent and willing to participate.
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Age: 13≥ years ≥6
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Gender: male and female
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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),
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Clinical Global Impression of Severity of illness (CGI-S) rating of 4 or higher (moderately ill or worse),
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Language: Subjects, parents, and teachers must be able to read, write and speak Hebrew
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Normal weight and height according to the Israeli standards
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Attending full-time to school.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Phosphatidylserine-Omega3 - 2 Colored cellulose tainted with fishy odor -
- Primary Outcome Measures
Name Time Method Conners Rating Scale - School Version change from baseline in conners raiting scale at 15 weeks 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
Name Time Method Conners Rating Scale - Home Version change from baseline in conners raiting scale at 15 weeks 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 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
Trial Locations
- Locations (1)
ADHD Unit
🇮🇱Petach-Tiqva, Israel