Pediatric Bipolar Disorder Clinical Trial
Official title:
Neurometabolic Effects of the Essential Polyunsaturated Fatty Acids in Early-Onset Bipolar Disorder: A Magnetic Resonance Spectroscopy Study
This study is being done to detect the metabolic changes that Omega 3 fatty acid treatment has on the brain and to find out whether magnetic resonance spectroscopy (MRS) scan can detect metabolic differences between bipolar patients and healthy control participants.
Bipolar disorder (BP) is a chronic, complex and highly heterogeneous disease that has been
unrecognized or misdiagnosed in prepubertal children and adolescents. It is one of the most
disabling forms of childhood psychopathology and carries a striking human and economic cost.
A high percentage of children and adolescents with BP respond very poorly to existing
treatments. There is a significant need for studies identifying the developmentally
sensitive targets for novel therapeutic compounds for this truly disabling illness. A
growing range of novel therapeutic options for the treatment of BP are under investigation.
Highly unsaturated fatty acids of the omega-3 fatty acids are among the novel therapeutic
compounds considered in the treatment of adult patients with BP. However, the
mood-stabilizing efficacy and the neurometabolic effects of this naturally occurring dietary
components have not been examined in pediatric patients with BP.
The objective of this study is to identify magnetic resonance spectroscopic characteristics
of adolescents with BP before and during a double-blind, placebo controlled combined omega-3
fatty and omega -6 fatty acid trial. We will compare the spectroscopic findings of the BP
group with individually matched healthy comparison subjects before and after the
omega-3/omega-6 fatty acid treatment. We will identify a well-described cohort of
adolescents (age: 12-18) with BP without catatonic features, psychotic features, or other
psychiatric comorbidity. Comorbidity with ADHD will be allowed since this might be a
separate phenotype for pediatric BP. We will analyze the differences between BP subjects
with comorbid ADHD, and BP subjects without ADHD. We will evaluate subjects with a novel
magnetic resonance imaging technique, Magnetic Resonance Spectroscopic Imaging (MRSI). We
will use a high-field 3T magnet to perform the MRSI acquisition, and apply a tissue volume
correction technique to compare absolute metabolite concentrations rather than metabolite
ratios. Previous studies found pronounced abnormalities in the frontal lobes, cingulate
cortex, thalamus and basal ganglia of patients with BP. Thus, the region of interest in this
study will include these anatomical areas with special emphasis given to prefrontal cortex
and anterior cingulate cortex.
To our knowledge, this will be the first study examining omega-3 fatty acid induced changes
in the developing brain in vivo. The long-term goal of our research group is to identify the
developmentally sensitive, trait and state related magnetic resonance spectroscopic markers
of pediatric BP. The preliminary data obtained from this application will be used to design
a larger scale, follow-up study to examine whether alterations in brain metabolite measures
are clinical state or trait markers and to determine the developmental variability in the
patterns of metabolic abnormalities. Such knowledge will provide powerful insight into
developmentally sensitive targeted pharmacological interventions. Studying bipolar disorder
early in its course will be important to minimize potentially confounding factors, such as
the effects of long-term medication use and neurodegeneration related to chronic illness
course and substance abuse.
Based on the existing literature, we hypothesized that increased myoinositol levels will be
detected in the regions of interests of adolescents with BP in comparison to healthy
controls.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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