The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder
Condition: Attention Deficit/Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Phosphatidylserine-Omega3; Colored cellulose tainted with fishy odor
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 6 Years
Maximum age: 13 Years
Healthy volunteers: No
Keywords: ADHD; inattentive; impulsive; hyperactive; poor academic performance; poor self-discipline; low self-esteem

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.
    

Eligibility 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.