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Omega-3 Fatty Acids for MDD with High Inflammation: A Personalized Approach


Title Omega-3 Fatty Acids for MDD with High Inflammation: A Personalized Approach
Therapeutic Area Depression, Obesity
Principal Investigator David Mischoulon, MD, PhD
Min Age 18 Years
Max Age 80 Years
Gender Both
Contact Stefania Lamon-Fava, MD PhD
617 556 3105
More Information https://clinicaltrials.gov/ct2/show/NCT02553915

Overview

The purpose of this research study is to compare the effects of three different doses of an investigational omega-3 fatty acid dietary supplement, eicosapentaenoic acid (EPA), versus placebo on immune system markers in the blood and on treating the symptoms of major depression. Placebo is a pill that looks like the study drug, but contains no active substance. Eicosapentaenoic acid (EPA) is a common omega-3 fatty acid. EPA is available in low dosages in some types of dietary supplements found in health food stores.

In order to qualify for this study you cannot be taking any antidepressants, and you must have a BMI of >25.

If you qualify, you will be randomly assigned (like the flip of a coin) to the EPA or placebo treatment group. You will have a 25% (1 in 4) chance of being assigned to one of the following groups:

  • Group 1 will receive capsules containing an EPA enriched omega-3 fatty acid preparation for a total dose of 1 g/day.
  • Group 2 will receive capsules containing an EPA enriched omega-3 fatty acid preparation for a total dose of 2 g/day.
  • Group 3 will receive capsules containing an EPA enriched omega-3 fatty acid preparation for a total dose of 4 g/day.
  • Group 4 will receive capsules containing placebo (an inactive substance).

Neither you nor the investigator will know to what group you are assigned. This is to make sure that the research study results are not affected by what you or the investigator may expect to happen.

We will ask you to make 9 visits over the course of 12 weeks to our clinic at MGH. At each visit you will meet with a clinician to fill out a number of questionnaires to monitor your progress and you will also receive study medication for the duration of the study. Blood samples will also be collected six times during this study, twice to determine your eligibility to participate in the study, and 4 times to measure changes in immune markers.

You can receive up to $280 total, if you complete all study visits. If you have to drive to come to MGH, you will also be provided with parking vouchers at all visits for the MGH garages. At the conclusion of the study, you will be offered 3 months of free follow up care with one of the study physicians.

Study Details

Inclusion Criteria

  • Screening visit high-sensitivity C-reactive protein concentration > 3 mg/L
  • Currently overweight at screening, defined as BMI > 25 kg/m2
  • Have a current primary psychiatric diagnosis of major depressive disorder .

Exclusion Criteria

  • Use of any psychotropic agents within 2 weeks of baseline or at any time during the study, with the exception of prescription hypnotics (eszopiclone, zaleplon, zolpidem, suvorexant, ramelteon), diphenhydramine, or a stable daily dose of a benzodiazepine
  • Meeting DSM-5 criteria at any point in their lifetime, for any of the following:
    • Neurocognitive Disorder,
    • Psychotic Disorder
    • Bipolar disorder
    • Anorexia Nervosa
  • Serious or unstable medical illness that in the investigator’s opinion could compromise response to treatment or interpretation of study results.

    Study Requirements

    We will ask you to make 9 visits over the course of 12 weeks to our clinic at MGH. At each visit you will meet with a clinician to fill out a number of questionnaires to monitor your progress and you will also receive study medication for the duration of the study. Blood samples will also be collected six times during this study, twice to determine your eligibility to participate in the study, and 4 times to measure changes in immune markers.

    You can receive up to $280 total, if you complete all study visits. If you have to drive to come to MGH, you will also be provided with parking vouchers at all visits for the MGH garages. At the conclusion of the study, you will be offered 3 months of free follow up care with one of the study physicians.