Omega 3 Fatty Acid Trial
Condition: Omega-3 Fatty Acids; Pediatric Bipolar Disorder; Adolescent Bipolar Disorder; Magnetic Resonance Spectroscopy Imaging
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Omega-3 Fatty Acid; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 600 mg of eicosapentaenoic acid, 340 g of docosahexanoic acid, and 96 mg gama-linoleic acid for 12 weeks.; placebo pill of the same size, color, and shape as the dietary supplement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Omega-3 Fatty Acids; Pediatric Bipolar Disorder; Adolescent Bipolar Disorder; MRS