Omega-3 Fatty Acids as an Adjunctive Therapy for Stimulants in Children With ADHD
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Purpose
Multiple forms of Omega-3 Fatty acids have been used to investigate the role of this food supplement in children with 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Dietary Supplement: Stimulants plus Lovaza (drug) Drug: Stimulants plus Placebo (instead of Lovaza) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Omega-3 Fatty Acids as an Adjunctive Therapy for Stimulants in Children With ADHD |
- Conners RATING SCALE (PASRENTS AND TEACHERS) [ Time Frame: 16 WEEKS ] [ Designated as safety issue: No ]
- CGI SCALE [ Time Frame: 16 WEEKS ] [ Designated as safety issue: No ]
| Enrollment: | 15 |
| Study Start Date: | December 2009 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Stimulants plus Lovaza
Usual dose of stimulant plus Lovaza (prescription Omega-3 fatty acids) at a Dose of 1800 mg daily.
|
Dietary Supplement: Stimulants plus Lovaza (drug)
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
Other Name: Lovaza plus stimulants
|
|
Placebo Comparator: Stimulants plus PLacebo
Usual dose of stimulants plus placebo(corn oil), which will be given to the patients by MMC's pharmacy.
|
Drug: Stimulants plus Placebo (instead of Lovaza)
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 Name: Sugar pill plus Stimulants
|
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 Conner's 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 Conner's rating scale.
The ratings of the Conner's 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 Conner's 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 Conner's 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 GSK. This pharmaceutical company will provide the capsules and the placebo.
Eligibility| Ages Eligible for Study: | 6 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male and female Children 6 to 15 years old Diagnosis of ADHD according to the DSM IV -TR
-
Exclusion Criteria:
- 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 Children with hypersensitivity to fish Children "In care" (CiC): Forster 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
Contacts and Locations| United States, New York | |
| Maimonides Medical Center | |
| Brooklyn, New York, United States, 11219 | |
| Principal Investigator: | Kathleen Malloy, MD | Maimonides Medical Center |
| Study Director: | Juan D Pedraza, MD | Maimonides Medical Center |
More Information
No publications provided
| Responsible Party: | Merlin Xavier, Clinical Research Coordinator, Maimonides Medical Center |
| ClinicalTrials.gov Identifier: | NCT01778647 History of Changes |
| Other Study ID Numbers: | LVZ113607 |
| Study First Received: | September 30, 2010 |
| Last Updated: | January 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Maimonides Medical Center:
|
ADHD Omega- 3 Fatty acids CGI Conners rating scale Stimulants |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013