Pediatric Bipolar Spectrum Disorders Clinical Trial
Official title:
A Randomized Controlled Trial of Inositol and Omega-3 Fatty Acids in Pediatric Mania
The purpose of this study is to a) evaluate the efficacy of omega-3 fatty acids versus inositol in the treatment of pediatric bipolar disorder, b) evaluate the efficacy of omega-3 fatty acid plus inositol in the treatment of pediatric bipolar disorder, and c) assess the side effect profile of omega-3 fatty acids plus inositol. This study will be a 12-week trial with children ages 5-12 years old with bipolar spectrum disorders.
The investigators propose to conduct a randomized, double blind, controlled trial that will
evaluate effectiveness and tolerability of omega-3 fatty acids and inositol used alone and in
combination. The investigators plan to decrease the variability in the population under study
by limiting the age range to 5-12 years and excluding cases with significant, untreated,
comorbidity. The cognitive effects/side effects with a neuropsychological battery pre and
post treatment will be measured. Subjects with a history of failing treatment with two or
more conventional treatments will be excluded.
This will be a 12-week, double-blind, randomized clinical trial study to compare efficacy and
tolerability of the natural treatments omega-3 fatty acids and inositol used in combination
in the treatment of bipolar spectrum disorders in children and adolescents (ages 5-12).
Subjects will be randomized in double blind fashion to one of three arms: omega-3 fatty
acids, inositol or the combined treatment. Further, the proposed study will include measures
of cognition prior to starting study medication and at endpoint. The investigators will
minimize the variability of the population under study by limiting the age range to 5-12
years, minimizing untreated or clinically significant comorbidity and excluding subjects who
have already failed treatment with 2 or more anti-manic agents. Subjects will include youth
ages 5-12 years with a bipolar spectrum disorder (type I, II, or NOS), mixed, manic, or
hypomanic state, according to the Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition (American Psychiatric Association, 2000) (DSM-IV), randomized to 3 treatment
arms: 1) treatment with omega-3 fatty acids (N=20); 2) treatment with inositol (N=20); 3)
treatment with the combination of inositol and omega-3 fatty acids (N=20).
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