Clinical trial NCT00418184: The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit/Hyperactivity Disorder (ADHD)
Keywords: ADHD
inattentive
impulsive
hyperactive
poor academic performance
poor self-discipline
low self-esteem
Lead sponsor: Enzymotec
Sponsor class: INDUSTRY
First posted: 2007-01-04
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Conners Rating Scale - School Version
timeFrame: change from baseline in conners raiting scale at 15 weeks
Secondary outcomes:
measure: Conners Rating Scale - Home Version
timeFrame: change from baseline in conners raiting scale at 15 weeks
measure: Strength and Difficulties Questionnaires - School Version
timeFrame: on weeks 0,15
measure: Strength and Difficulties Questionnaires - Home Version
timeFrame: on weeks 0,15
measure: Clinical Global Impression of Improvement
timeFrame: on weeks 0,15
measure: Test of Variables of Attention (TOVA)
timeFrame: on weeks 0,15
measure: Child Health Questionnaire (CHQ)- Parent-completed Form 50
timeFrame: on weeks 0,15
measure: Plasma and Red Blood Cells Fatty Acid Profile
timeFrame: on weeks 0,15
measure: Blood Monoamines Metabolism
timeFrame: on week 0, 15
measure: Vital Signs
timeFrame: on weeks 0,15
measure: Essential Fatty Acid (EFA)-Deficiency Symptoms
timeFrame: on weeks 0,15
measure: Barkley Side Effects Rating Scale (SERS)
timeFrame: on weeks 0,15
measure: Complete Blood Counts
timeFrame: on weeks 0,15
measure: Biochemical Parameters in Blood - Liver Functions (SGPT, SGOT, Total Bilirubin), Kidney Functions (BUN, Creatinine), Na, K, Cl, Ca
timeFrame: on weeks 0,15
measure: Lipid Profile (Cholesterol, HDL, Triglycerides)
timeFrame: on weeks 0,15
Other outcomes:
Locations:
city: Petach-Tiqva
country: Israel
facility: ADHD Unit
Study officials:
affiliation: Head of the Research Department, Geha Mental Health Center, Rabin Medical Center
name: Abraham Weizman, MD
role: STUDY_DIRECTOR
References:
citation: Manor I, Magen A, Keidar D, Rosen S, Tasker H, Cohen T, Richter Y, Zaaroor-Regev D, Manor Y, Weizman A. The effect of phosphatidylserine containing Omega3 fatty-acids on attention-deficit hyperactivity disorder symptoms in children: a double-blind placebo-controlled trial, followed by an open-label extension. Eur Psychiatry. 2012 Jul;27(5):335-42. doi: 10.1016/j.eurpsy.2011.05.004. Epub 2011 Jul 31.