Omega 3 Fatty Acid Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586222
• Other study ID #: 06-004285
• Status: Completed
• Phase: Phase 1
• First received: December 21, 2007
• Last updated: January 24, 2012
• Start date: January 2007
• Est. completion date: March 2010

Study information

• Verified date: January 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• 12 to 18 years old

• both male and female

• all ethnic backgrounds

• DSM-IV criteria for Bipolar Disorder without catatonic and psychotic features or other psychiatric comorbidity, except ADHD

Exclusion Criteria:

• cardiac pacemakers

• metallic clips

• other bodily metallic implants

• dental braces

• not fluent in English

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Adolescent Bipolar Disorder
• Bipolar Disorder
• Disease
• Magnetic Resonance Spectroscopy Imaging
• Omega-3 Fatty Acids
• Pediatric Bipolar Disorder

Intervention

Dietary Supplement:
• Omega-3 Fatty Acid
600 mg of eicosapentaenoic acid, 340 g of docosahexanoic acid, and 96 mg gama-linoleic acid for 12 weeks.

Other:
• Placebo
placebo pill of the same size, color, and shape as the dietary supplement.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cases will classify as either treatment responders or non. Using dichotomous assessment, logistic regression will assess association of regional mI levels and mood measures taken at baseline, adjusting for important covariates such as age and gender.		at the 12 week point	No