Omega-3 Fatty Acids as an Adjunctive Therapy for Treatment in Attention-Deficit Hyperactivity Disorder (ADHD)

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.