View Clinical Trial (Medical Research Study)
Omega-3 Fatty Acids as an Adjunctive Therapy for Stimulants in Children With ADHD
| City: |
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Brooklyn |
| State: |
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New York |
| Zip Code: |
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11219 |
| Conditions: |
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Attention-Deficit/Hyperactivity Disorder |
| Purpose: |
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Type of study:
This study is a prospective, randomized, placebo controlled, double blind trial comparing
the response to treatment in children with a diagnosis of ADHD treated with stimulants and
placebo vs. children with a diagnosis of ADHD on stimulants plus Omega-3 fatty acids.
Hypothesis:
The use of Lovaza (prescription Omega-3 fatty acids) as an adjunctive therapy for children
with adequate diagnosis of ADHD on treatment with stimulants will not improve their
functioning and behavior measured by the Parent and Teacher Conner's Rating Scale and an
improvement in their Clinical Global Impression.
Method:
A total of 30-150 patients between ages of 6 and 15 y/o with diagnosis of ADHD according to
the DSM-IV-TR and on current treatment with stimulants recruited from CAOS-Maimonides
Medical Center 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). Patients will be divided in two groups, one will consist of 15 children taking
usual dose of stimulants plus placebo and the other group, 15 children will receive the
usual dose of stimulant plus Lovaza at a dose of 1800mg daily. Both groups will be treated
for 8 weeks. Patients will be re-evaluated by 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.
Ratings of the Conner's scales filled out for each patient will be analyzed and compared to
the initial evaluation after week 8. Evaluators will also obtain a CGI score for each
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 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 idea is to conduct the study and obtain information about prescription Omega-3 fatty
acids as an adjunct to stimulants for patients with ADHD, as several publications have been
done in the past suggesting it can be beneficial, but there have not been any conclusions on
whether the treatment is beneficial or not for this population.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Male and female children ages from 6-15 y/o (inclusive)
- 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
- Children with Mental Retardation
- History of poor compliance with treatment
- Children with blood clotting problems
- Children currently under treatment with anticoagulants
- Children with hypersensitivity to fish
- Children "In Care": 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
- Pregnancy
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| NCT ID: |
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NCT01233856 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Brooklyn, New York 11219
United States
Jose M Torrijos, MD
Phone: 718-283-8828
Email: jtorrijos@maimonidesmed.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 17, 2013 |
| Modifications to this listing: |
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