Pediatric Bipolar Disorder Clinical Trial
Official title:
A Randomized Placebo Controlled Clinical Trial of Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents Ages 6-17 With Bipolar Spectrum Disorder
This will be a 12 week, double blind study of omega-3 fatty acids vs. placebo adjunctive to
open-label aripiprazole treatment in children and adolescents (ages 6-17) who meet DSM-IV
criteria for bipolar disorder (BPD) (currently manic or mixed). Specific hypotheses are as
follows:
Hypothesis 1: Omega-3 fatty acids will be well-tolerated and efficacious in the treatment of
children and adolescents with BPD
Hypothesis 2: The total dose of aripiprazole will be lower in those subjects receiving
active omega-3 treatment
Initial clinical evidence suggests that the omega-3 fatty acids EPA (eicosapentaenoic acid)
and/or DHA (docosahexaenoic acid) may play a therapeutic role in the management of mood
disorders. EPA is an essential fatty acid, which can be metabolized to DHA and is a
component of the human diet if fish is consumed. Aripiprazole is a novel second general
antipsychotic that seems to function as a partial agonist at the dopamine D2 and serotonin
5-HT 1A receptors as well as an antagonist at the serotonin 5-HT 2A receptor. Since it has a
favorable adverse event profile in adults, it is an attractive choice for the treatment of
youth with bipolar disorder if proven efficacious. Although pilot research showed that
omega-3 fatty acids monotherapy treatment resulted in improvement of manic symptoms, the
improvement is less dramatic than that observed in trials of antipsychotics. We will test
the safety and efficacy of omega-3 fatty acids versus placebo as an adjunctive treatment to
open-label aripiprazole in children and adolescents with bipolar disorder.
The proposed study includes 1) the use of a 12-week design to document the response rate 2)
careful assessment of safety and tolerability
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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