The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder

Enzymotec

Status and phase: Completed; Phase 2

Conditions: Attention Deficit/Hyperactivity Disorder (ADHD)

Treatments: Other: Colored cellulose tainted with fishy odor; Dietary Supplement: Phosphatidylserine-Omega3

Study type: Interventional

Funder types: Industry

Identifiers

NCT00418184

PS-Omega3-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 6 to 13 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Dietary Supplement: Phosphatidylserine-Omega3

2

Placebo Comparator group

Treatment:

Other: Colored cellulose tainted with fishy odor