Attention Deficit/Hyperactivity Disorder (ADHD)Phase 2NCT00418184
The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder
A Phase 2 study testing Phosphatidylserine-Omega3 and Colored cellulose tainted with fishy odor in people with Attention Deficit/Hyperactivity Disorder (ADHD), run by Enzymotec at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder (ADHD)
- What is being tested?
- Phosphatidylserine-Omega3 and Colored cellulose tainted with fishy odor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2007to Nov 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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),
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Phosphatidylserine-Omega3, Colored cellulose tainted with fishy odor
- Keywords
- ADHD, inattentive, impulsive, hyperactive, poor academic performance, poor self-discipline, low self-esteem
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Impulsive Behavior, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phosphatidylserine-Omega3Dietary supplement
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.
Colored cellulose tainted with fishy odorOther
as arm 1
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: Phosphatidylserine-Omega3 |
| 2 | Placebo comparator | Not described Receives: Other: Colored cellulose tainted with fishy odor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline in conners raiting scale at 15 weeks
Secondary outcomes (14)
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.
Measured: change from baseline in conners raiting scale at 15 weeks
Strength and Difficulties Questionnaires - School Version
Measured: on weeks 0,15
Strength and Difficulties Questionnaires - Home Version
Measured: on weeks 0,15
Clinical Global Impression of Improvement
Measured: on weeks 0,15
Test of Variables of Attention (TOVA)
Measured: on weeks 0,15
Child Health Questionnaire (CHQ)- Parent-completed Form 50
Measured: on weeks 0,15
Plasma and Red Blood Cells Fatty Acid Profile
Measured: on weeks 0,15
Blood Monoamines Metabolism
Measured: on week 0, 15
Vital Signs
Measured: on weeks 0,15
Essential Fatty Acid (EFA)-Deficiency Symptoms
Measured: on weeks 0,15
Barkley Side Effects Rating Scale (SERS)
Measured: on weeks 0,15
Complete Blood Counts
Measured: on weeks 0,15
Biochemical Parameters in Blood - Liver Functions (SGPT, SGOT, Total Bilirubin), Kidney Functions (BUN, Creatinine), Na, K, Cl, Ca
Measured: on weeks 0,15
Lipid Profile (Cholesterol, HDL, Triglycerides)
Measured: on weeks 0,15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startMar 2007
- Primary completionNov 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit/Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzymotec
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Abraham Weizman, MD, Study director, Head of the Research Department, Geha Mental Health Center, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418184
- Sponsor's protocol ID
- PS-Omega3-2
- Status last verified
- Jan 2010
- First submitted
- 31 Dec 2006
- Last updated
- 12 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 21807480
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00418184
- Acronym / sponsor ID
- PS-Omega3-2
- Keywords
- ADHD, inattentive, impulsive, hyperactive, poor academic performance, poor self-discipline, low self-esteem
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- EnzymotecIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 4 Jan 2007 (estimated)
- Results
- Posted 26 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Phosphatidylserine-Omega3 |
| 2 | Placebo comparator | Other: Colored cellulose tainted with fishy odor |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phosphatidylserine-Omega3Phosphatidylserine-Omega3 conjugate capsules. Weeks 0-15: 300 mg/day. weeks 16-30: 150 mg/day and a 150 mg/day one year follow-up. | Dietary supplement | 1 |
| Colored cellulose tainted with fishy odoras arm 1 | Other | 2 |
Primary outcome
Conners Rating Scale - School Version
Time frame: change from baseline in conners raiting scale at 15 weeks
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.
14 secondary outcomes
Conners Rating Scale - Home Version
Time frame: change from baseline in conners raiting scale at 15 weeks
Strength and Difficulties Questionnaires - School Version
Time frame: on weeks 0,15
Strength and Difficulties Questionnaires - Home Version
Time frame: on weeks 0,15
Clinical Global Impression of Improvement
Time frame: on weeks 0,15
Test of Variables of Attention (TOVA)
Time frame: on weeks 0,15
Child Health Questionnaire (CHQ)- Parent-completed Form 50
Time frame: on weeks 0,15
Plasma and Red Blood Cells Fatty Acid Profile
Time frame: on weeks 0,15
Blood Monoamines Metabolism
Time frame: on week 0, 15
Vital Signs
Time frame: on weeks 0,15
Essential Fatty Acid (EFA)-Deficiency Symptoms
Time frame: on weeks 0,15
Barkley Side Effects Rating Scale (SERS)
Time frame: on weeks 0,15
Complete Blood Counts
Time frame: on weeks 0,15
Biochemical Parameters in Blood - Liver Functions (SGPT, SGOT, Total Bilirubin), Kidney Functions (BUN, Creatinine), Na, K, Cl, Ca
Time frame: on weeks 0,15
Lipid Profile (Cholesterol, HDL, Triglycerides)
Time frame: on weeks 0,15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21807480Manor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abraham Weizman, MD study director
Head of the Research Department, Geha Mental Health Center, Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phosphatidylserine-Omega3 and Colored cellulose tainted with fishy odor in people with Attention Deficit/Hyperactivity Disorder (ADHD), run by Enzymotec at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conners Rating Scale - School Version (time frame: change from baseline in conners raiting scale at 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00418184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2014.