Omega-3 Fatty Acids as an Adjunctive Therapy for Stimulants in Children With ADHD
NCT ID: NCT01778647
Last Updated: 2023-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
15 participants
INTERVENTIONAL
2009-12-31
2010-07-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Stimulants plus Lovaza
Usual dose of stimulant plus Lovaza (prescription Omega-3 fatty acids) at a dose of 1800 mg daily.
Stimulants plus Lovaza
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 placebo
Usual dose of stimulants plus placebo(corn oil), which will be given to the patients by MMC's pharmacy.
Stimulants plus placebo
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.
Interventions
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Stimulants plus Lovaza
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 placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of ADHD according to the DSM IV -TR
Exclusion Criteria
* 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
* 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
6 Years
15 Years
ALL
No
Sponsors
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Antonios Likourezos
OTHER
Responsible Party
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Antonios Likourezos
Research Administration Director
Principal Investigators
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Kathleen Malloy, MD
Role: PRINCIPAL_INVESTIGATOR
Maimonides Medical Center
Juan D Pedraza, MD
Role: STUDY_DIRECTOR
Maimonides Medical Center
Locations
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Maimonides Medical Center
Brooklyn, New York, United States
Countries
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References
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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.
Other Identifiers
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09/06/VA05
Identifier Type: OTHER
Identifier Source: secondary_id
LVZ113607
Identifier Type: -
Identifier Source: org_study_id
NCT01233856
Identifier Type: -
Identifier Source: nct_alias