Status:
COMPLETED
The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder
Lead Sponsor:
Enzymotec
Conditions:
Attention Deficit/Hyperactivity Disorder (ADHD)
Eligibility:
All Genders
6-13 years
Phase:
PHASE2
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 ...
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, accordin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00418184
Start Date
March 1 2007
End Date
November 1 2009
Last Update
March 12 2014
Active Locations (1)
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1
ADHD Unit
Petach-Tiqva, Israel, 49100