Omega-3 Fatty Acids as an Adjunctive Therapy for Stimulants in Children With ADHD
| Status: | Terminated |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 6 - 15 |
| Updated: | 8/25/2018 |
| Start Date: | December 2009 |
| End Date: | July 2010 |
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.
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.
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.
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.
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): 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
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