Omega-3 Fatty Acids for Treating Adults With Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will test the effectiveness of two different kinds of omega-3 fatty acid dietary
      supplements in treating the symptoms of major depression.
    

Detailed description: 
      Major depression is a common mental disorder that affects millions of people each year. It
      can severely impact a person's life, causing someone to often feel sad and hopeless, as well
      as affect a person's sleep patterns, concentration, and energy levels. Despite the
      availability of numerous therapies, current treatments are not ideal for some people.
      Recently, some research has shown that an increase in dietary intake of polyunsaturated fatty
      acids (PUFAs), such as omega-3 fatty acid, might help treat depression. Eicosapentanoic acid
      (EPA) and docosahexanoic acid (DHA) are two common types of PUFAs high in omega-3 fatty acids
      and are available in low dosages in some dietary supplements. The purpose of this study is to
      compare the effectiveness of an EPA-enriched mixture versus pure DHA versus a placebo in
      treating the symptoms of major depression.

      Participants in this double blind study will be randomly assigned to one of three study
      groups. Participants assigned to the first study group will receive capsules containing 500
      mg of an EPA-enriched omega-3 fatty acid preparation. Participants assigned to the second
      study group will receive capsules containing 500 mg of pure DHA. Participants assigned to the
      third study group will receive capsules containing a placebo. The study will last
      approximately 9 weeks. This will include an initial screening the first week followed by an
      8-week period during which all participants will take two capsules of their assigned
      treatment each morning. Participants will attend a total of six study visits. The initial
      visit will last approximately 2 hours and will include a psychiatric assessment, urine and
      blood collection, an electrocardiogram (EKG), and a Food Processor Questionnaire.
      Participants who qualify for further participation will then enter a 1-week washout period
      during which they will stop taking any current psychotropic medication. At the second study
      visit, participants will be assigned to their treatment group. Upon starting assigned
      treatments, participants will then return for study visits every 2 weeks to report any
      possible side effects and to complete standard psychiatric assessment tests. All of these
      study visits will take approximately 1 hour, except the last, which will take 2 hours. In
      addition to the psychiatric assessment and review of side effects, the final study visit will
      also include a physical exam and blood collection.
    

Intervention name(s): EPA omega-3 fatty acid; DHA omega-3 fatty acid; Placebo comparator
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1 gram per day of an EPA-enriched mixture for 8 weeks; 1 gram per day of pure DHA for 8 weeks; 1 gram per day of an inactive substance for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major Depression; Omega-3; Major Depressive Disorder