Attention Deficit Hyperactivity DisorderPhase 4NCT01778647
Omega-3 Fatty Acids as an Adjunctive Therapy for Stimulants in Children With ADHD
A Phase 4 study testing Stimulants plus Lovaza in people with Attention Deficit Hyperactivity Disorder, run by Antonios Likourezos at 1 site in United States.
Trial summary
Multiple forms of Omega-3 Fatty acids have been used to investigate the role of this food supplement in children with Attention Deficit Hyperactivity Disorder (ADHD). No clear evidence for their role in this disorder is yet available. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Stimulants plus Lovaza
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jul 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female Children 6 to 15 years old
- Diagnosis of ADHD according to the DSM IV -TR
Who cannot join
- Children younger than 6 y/o or older than 15 y/o
- Children with other co-morbid disorders according to the DSM IV-TR
- Mentally retarded children
- Poor compliance with treatment
- Children with a diagnosis of blood clotting problems
- Children on anticoagulants
Show all 10Show fewer
- Children with hypersensitivity to fish
- Children "In care" (CiC): Foster children or children that are not being taken care of by a biological parent or a legal guardian.
- Children who follow a kosher diet (Lovaza is not kosher)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Multiple forms of Omega-3 Fatty acids have been used to investigate the role of this food supplement in children with Attention Deficit Hyperactivity Disorder (ADHD). No clear evidence for their role in this disorder is yet available. We will conduct a prospective, randomized, double blind, placebo controlled trial to obtain significant results regarding this question.
Read the detailed description
A total of 30-150 patients or more between the ages of 6 and 15 years old with diagnosis of ADHD according to the DSM-IV and on current treatment with stimulants recruited from CAOS-MMC and the Developmental Center will be evaluated by a child psychiatrist or a resident under supervision of a child psychiatrist to make sure that the diagnosis is correct. Every child will have a Conners rating scale filled out by the parents and teachers on admission to the study. The evaluators will also fill out a Clinical Global Impression scale (CGI).
The patients will be divided in 2 groups. One group of 15 children will be randomized to continue taking the usual dose of stimulants plus placebo (corn oil), which will be given to the patients by MMC's pharmacy.
A second group of 15 patients will be randomized to receive the usual dose of stimulant plus Lovaza (prescription Omega-3 fatty acids) at a dose of 1800 mg daily.
Both groups will be initially treated for a period of 8 weeks. The patients will be re-evaluated by the investigators on week 2, 4, 6 and 8 of the study and on each evaluation the parents and teachers will fill out a Conners rating scale.
The ratings of the Conners rating scales filled for each patient will be analyzed and compared to the initial evaluation after week 8. The evaluators will also do a CGI score for every visit.
Patients that improve will be taken off the stimulants and will continue further treatment with the adjunctive therapy for a total of 4 more weeks, during this period of time they will be re-evaluated on weeks 9, 10 and 12 and Conners scales will also be filled out by the parents.
Patients who do not improve will be switched to the opposite treatment modality and will be evaluated on weeks 9, 10 and 12 also having Conners scales filled out by their parents. If any of the patients in this group improve after the switch, they will be taken off stimulants and they will be evaluated on weeks 13, 14 and 16 of the study arm.
The study will be supported by GlaxoSmithKline. This pharmaceutical company will provide the capsules and the placebo.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Stimulants plus Lovaza, Stimulants plus placebo
- Keywords
- ADHD, Omega- 3 Fatty acids, CGI, Conners rating scale, Stimulants
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulants plus LovazaDietary supplement
Also called Lovaza plus stimulants
Patients randomized to stimulants plus Lovaza (Omega-3 fatty acids). Treated and evaluated for up to 16 weeks. Conners and CGI scales filled out by parents, teachers and evaluators on each visit
Stimulants plus placeboDrug
Also called Sugar pill plus stimulants
Patients randomized to usual dose of stimulants plus placebo. Patients evaluated for up to 16 weeks. Conners rating scales and CGI filled out by evaluators, parents and teachers.
| Study group | Role | What they receive |
|---|---|---|
| Stimulants plus Lovaza | Experimental | Usual dose of stimulant plus Lovaza (prescription Omega-3 fatty acids) at a dose of 1800 mg daily. Receives: Dietary Supplement: Stimulants plus Lovaza |
| Stimulants plus placebo | Placebo comparator | Usual dose of stimulants plus placebo(corn oil), which will be given to the patients by MMC's pharmacy. Receives: Drug: Stimulants plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conners Rating Scale for assessment of ADHD characteristics
Conners Rating Scales is designed to provide an overview of child and adolescent concerns and disorders, including ADHD. The survey for parents contains 80 items and 59 items for teachers. Scoring is based on a response about specific aspects of child behavior, with a low cumulative score showing less likelihood of a specific disorder. The cumulative score is called a T-score. T-scores have a mean of 50 and a standard deviation of 10. These can be converted to percentile scores. T-scores above 60 are cause for concern and have interpretive value. Interpretable scores range from a low T-score of 61 (mildly atypical) to above 70 (markedly atypical).
Measured: 16 WEEKS
Secondary outcomes (1)
Clinical Global Impression - Severity Scale (CGI-S)
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The CGI-Severity (CGI-S) asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
Measured: 16 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startDec 2009
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Co-Investigators left the Institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonios Likourezos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonios Likourezos, Maimonides Medical Center
- Investigators
- Kathleen Malloy, MD, Principal investigator, Maimonides Medical CenterJuan D Pedraza, MD, Study director, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778647
- Sponsor's protocol ID
- LVZ113607
- Other IDs
- 09/06/VA05
- Status last verified
- Dec 2023
- First submitted
- 30 Sep 2010
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.
PubMed 37058600
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids as an Adjunctive Therapy for Stimulants in Children With ADHD
- ClinicalTrials.gov ID
- NCT01778647
- Acronym / sponsor ID
- LVZ113607
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Omega- 3 Fatty acids, CGI, Conners rating scale, Stimulants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Co-Investigators left the Institution.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Antonios LikourezosUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple forms of Omega-3 Fatty acids have been used to investigate the role of this food supplement in children with Attention Deficit Hyperactivity Disorder (ADHD). No clear evidence for their role in this disorder is yet available. We will conduct a prospective, randomized, double blind, placebo controlled trial to obtain significant results regarding this question.
Detailed description
A total of 30-150 patients or more between the ages of 6 and 15 years old with diagnosis of ADHD according to the DSM-IV and on current treatment with stimulants recruited from CAOS-MMC and the Developmental Center will be evaluated by a child psychiatrist or a resident under supervision of a child psychiatrist to make sure that the diagnosis is correct. Every child will have a Conners rating scale filled out by the parents and teachers on admission to the study. The evaluators will also fill out a Clinical Global Impression scale (CGI).
The patients will be divided in 2 groups. One group of 15 children will be randomized to continue taking the usual dose of stimulants plus placebo (corn oil), which will be given to the patients by MMC's pharmacy.
A second group of 15 patients will be randomized to receive the usual dose of stimulant plus Lovaza (prescription Omega-3 fatty acids) at a dose of 1800 mg daily.
Both groups will be initially treated for a period of 8 weeks. The patients will be re-evaluated by the investigators on week 2, 4, 6 and 8 of the study and on each evaluation the parents and teachers will fill out a Conners rating scale.
The ratings of the Conners rating scales filled for each patient will be analyzed and compared to the initial evaluation after week 8. The evaluators will also do a CGI score for every visit.
Patients that improve will be taken off the stimulants and will continue further treatment with the adjunctive therapy for a total of 4 more weeks, during this period of time they will be re-evaluated on weeks 9, 10 and 12 and Conners scales will also be filled out by the parents.
Patients who do not improve will be switched to the opposite treatment modality and will be evaluated on weeks 9, 10 and 12 also having Conners scales filled out by their parents. If any of the patients in this group improve after the switch, they will be taken off stimulants and they will be evaluated on weeks 13, 14 and 16 of the study arm.
The study will be supported by GlaxoSmithKline. This pharmaceutical company will provide the capsules and the placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulants plus Lovaza | Experimental | Dietary Supplement: Stimulants plus LovazaUsual dose of stimulant plus Lovaza (prescription Omega-3 fatty acids) at a dose of 1800 mg daily. |
| Stimulants plus placebo | Placebo comparator | Drug: Stimulants plus placeboUsual dose of stimulants plus placebo(corn oil), which will be given to the patients by MMC's pharmacy. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male and female Children 6 to 15 years old
- Diagnosis of ADHD according to the DSM IV -TR
Key exclusion criteria (10 listed)
- Children younger than 6 y/o or older than 15 y/o
- Children with other co-morbid disorders according to the DSM IV-TR
- Mentally retarded children
- Poor compliance with treatment
- Children with a diagnosis of blood clotting problems
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 |
|---|---|---|
| Stimulants plus LovazaAlso: Lovaza plus stimulantsPatients randomized to stimulants plus Lovaza (Omega-3 fatty acids). Treated and evaluated for up to 16 weeks. Conners and CGI scales filled out by parents, teachers and evaluators on each visit | Dietary supplement | Stimulants plus Lovaza |
| Stimulants plus placeboAlso: Sugar pill plus stimulantsPatients randomized to usual dose of stimulants plus placebo. Patients evaluated for up to 16 weeks. Conners rating scales and CGI filled out by evaluators, parents and teachers. | Drug | Stimulants plus placebo |
Primary outcome
Conners Rating Scale for assessment of ADHD characteristics
Time frame: 16 WEEKS
Conners Rating Scales is designed to provide an overview of child and adolescent concerns and disorders, including ADHD. The survey for parents contains 80 items and 59 items for teachers. Scoring is based on a response about specific aspects of child behavior, with a low cumulative score showing less likelihood of a specific disorder. The cumulative score is called a T-score. T-scores have a mean of 50 and a standard deviation of 10. These can be converted to percentile scores. T-scores above 60 are cause for concern and have interpretive value. Interpretable scores range from a low T-score of 61 (mildly atypical) to above 70 (markedly atypical).
1 secondary outcome
Clinical Global Impression - Severity Scale (CGI-S)
Time frame: 16 WEEKS
Results and safety
The study was stopped early (reason given: Co-Investigators left the Institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Derived from this study: PubMed 37058600Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.
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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.
Kathleen Malloy, MD principal investigator
Maimonides Medical Center
Juan D Pedraza, MD study director
Maimonides 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 4 study testing Stimulants plus Lovaza in people with Attention Deficit Hyperactivity Disorder, run by Antonios Likourezos at 1 site in United States.
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 2 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: stopped early, as of the sponsor's last update on 14 Dec 2023. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Co-Investigators left the Institution.). Results are not available in the source record.
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 for assessment of ADHD characteristics (time frame: 16 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 NCT01778647, 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 14 Dec 2023.