Depression Clinical Trial
Official title:
Omega-3 Fatty Acids for Treatment of Major Depression: Differential Effects of EPA and DHA, and Associated Biochemical and Immune Parameters
This study will test the effectiveness of two different kinds of omega-3 fatty acid dietary supplements in treating the symptoms of major depression.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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