Omega 3 Fatty Acid Trial

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00586222
First received: December 21, 2007
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Omega-3 Fatty Acids
Pediatric Bipolar Disorder
Adolescent Bipolar Disorder
Magnetic Resonance Spectroscopy Imaging
Dietary Supplement: Omega-3 Fatty Acid
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Neurometabolic Effects of the Essential Polyunsaturated Fatty Acids in Early-Onset Bipolar Disorder: A Magnetic Resonance Spectroscopy Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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. [ Time Frame: at the 12 week point ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: January 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2 Other: Placebo
placebo pill of the same size, color, and shape as the dietary supplement.
No Intervention: Healthy Comparsions
We will compare the BP group with 32 age-, gender-, and handedness-matched healthy adolescents. Subjects who have a first or second degree relative with a psychiatric history will be excluded from the healthy comparison group. Subjects must be safe to undergo MRI scanning as per Mayo MRI safety screening which is explained in detail elsewhere in this protocol. We will exclude the subjects with cardiac pacemakers, metallic clips, other bodily metallic implants and dental braces because of the MRS procedure. Subjects who cannot complete clinical assessments or the MRI scan and subjects who are not fluent in English will be excluded from the study.
Experimental: 1 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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586222

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Sencan S Unal, M.D. P Mayo Clinic
  More Information

No publications provided

Responsible Party: Sencan Solay Unal, M.D. P, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00586222     History of Changes
Other Study ID Numbers: 06-004285
Study First Received: December 21, 2007
Last Updated: January 24, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Omega-3 Fatty Acids
Pediatric Bipolar Disorder
Adolescent Bipolar Disorder
MRS

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014