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

Attention Deficit/Hyperactivity Disorder (ADHD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418184
• Other study ID #: PS-Omega3-2
• Status: Completed
• Phase: Phase 2
• First received: December 31, 2006
• Last updated: February 12, 2014
• Start date: March 2007
• Est. completion date: November 2009

Study information

• Verified date: January 2010
• Source: Enzymotec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 13 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit/Hyperactivity Disorder (ADHD)
• Hyperkinesis

Intervention

Dietary Supplement:
• Phosphatidylserine-Omega3
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.

Other:
• Colored cellulose tainted with fishy odor
as arm 1

Locations

Country	Name	City	State
Israel	ADHD Unit	Petach-Tiqva

Sponsors (1)

Lead Sponsor	Collaborator
Enzymotec

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conners Rating Scale - School Version	A questionnaire that assesses symptoms of ADHD in children and adolescents according to the DSM-IV guidelines. It consists of questions on classroom behavior. Based on the questionnaire results, subscales and global indexes are calculated, including restless-impulsive index, emotional lability index and hyperactive/impulsive subscale. The lowest scale score is 40 (best)and the highest is 90 (worse). Usually, a score below 62 is considered normal and a score above 62 is considered abnormal.	change from baseline in conners raiting scale at 15 weeks	No
Secondary	Conners Rating Scale - Home Version	A questionnaire that assesses symptoms of ADHD in children and adolescents according to the DSM-IV guidelines. It consists of questions on the childs home behavior. Based on the questionnaire results, subscales and global indexes are calculated, including restless-impulsive index, emotional lability index and hyperactive/impulsive subscale. The lowest scale score is 40 (best)and the highest is 90 (worse). Usually, a score below 62 is considered normal and a score above 62 is considered abnormal.	change from baseline in conners raiting scale at 15 weeks	No
Secondary	Strength and Difficulties Questionnaires - School Version		on weeks 0,15	No
Secondary	Strength and Difficulties Questionnaires - Home Version		on weeks 0,15	No
Secondary	Clinical Global Impression of Improvement		on weeks 0,15	No
Secondary	Test of Variables of Attention (TOVA)		on weeks 0,15	No
Secondary	Child Health Questionnaire (CHQ)- Parent-completed Form 50		on weeks 0,15	No
Secondary	Plasma and Red Blood Cells Fatty Acid Profile		on weeks 0,15	Yes
Secondary	Blood Monoamines Metabolism		on week 0, 15	Yes
Secondary	Vital Signs		on weeks 0,15	Yes
Secondary	Essential Fatty Acid (EFA)-Deficiency Symptoms		on weeks 0,15	Yes
Secondary	Barkley Side Effects Rating Scale (SERS)		on weeks 0,15	Yes
Secondary	Complete Blood Counts		on weeks 0,15	Yes
Secondary	Biochemical Parameters in Blood - Liver Functions (SGPT, SGOT, Total Bilirubin), Kidney Functions (BUN, Creatinine), Na, K, Cl, Ca		on weeks 0,15	Yes
Secondary	Lipid Profile (Cholesterol, HDL, Triglycerides)		on weeks 0,15	Yes