Omega-3 Fatty Acids as an Adjunctive Therapy for Stimulants in Children With ADHD
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.
|Attention Deficit Hyperactivity Disorder||Dietary Supplement: Stimulants plus Lovaza (drug) Drug: Stimulants plus Placebo (instead of Lovaza)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
- CGI SCALE [ Time Frame: 16 WEEKS ]
|Study Start Date:||December 2009|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778647
|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|