Phase 2
N=200
The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder
Attention Deficit/Hyperactivity Disorder (ADHD)
Bottom Line
View on ClinicalTrials.gov: NCT00418184 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcome: Primary: Conners Rating Scale - School Version — -0.44; -1.73; -2.63; -0.63 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Phosphatidylserine-Omega3 (Dietary_supplement); Colored cellulose tainted with fishy odor (Other)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Enzymotec
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Conners Rating Scale - School Version |
-0.44; -1.73; -2.63; -0.63; -0.62; -0.46 | — |
| SECONDARY Conners Rating Scale - Home Version |
-5.19; -1.71; -3.54; -5.56; -4.23; -2.62 | — |
| SECONDARY Strength and Difficulties Questionnaires - School Version |
— | — |
| SECONDARY Strength and Difficulties Questionnaires - Home Version |
— | — |
| SECONDARY Clinical Global Impression of Improvement |
— | — |
| SECONDARY Test of Variables of Attention (TOVA) |
— | — |
| SECONDARY Child Health Questionnaire (CHQ)- Parent-completed Form 50 |
— | — |
| SECONDARY Plasma and Red Blood Cells Fatty Acid Profile |
— | — |
| SECONDARY Blood Monoamines Metabolism |
— | — |
| SECONDARY Vital Signs |
— | — |
| SECONDARY Essential Fatty Acid (EFA)-Deficiency Symptoms |
— | — |
| SECONDARY Barkley Side Effects Rating Scale (SERS) |
— | — |
| SECONDARY Complete Blood Counts |
— | — |
| SECONDARY Biochemical Parameters in Blood - Liver Functions (SGPT, SGOT, Total Bilirubin), Kidney Functions (BUN, Creatinine), Na, K, Cl, Ca |
— | — |
| SECONDARY Lipid Profile (Cholesterol, HDL, Triglycerides) |
— | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT00418184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.