Major Depressive Disorder Clinical Trial
With the dissatisfaction of monoamine-based pharmacotherapy and the high comorbidity of physical illness in depression, the serotonin hypothesis seems to fail in approaching the etiology of depression. Based upon the evidence from epidemiological data, case-control studies of PUFAs compositions, and antidepressant effects in clinical trials, phospholipid polyunsaturated fatty acids (PUFAs) is enlightening a promising path to discover the unsolved of depression.
There are several important questions to answer regarding phospholipid polyunsaturated fatty
acids (PUFAs) hypothesis of depression. Firstly, although case-control studies revealed that
depressive patients had lower levels of omega-3 PUFAs, the abnormal findings in individual
PUFA of docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) or arachidonic acid (AA) are
not consistent. Secondly, the deficits in n-3 PUFAs are related to their metabolic enzymes.
However, the association study of polymorphisms of PUFA-metabolism related genes in
depression is limited. Thirdly, the active component of antidepressant effect in n-3 PUFAs
is still in debate. Fourthly, the molecular mechanisms of n-3 PUFAs' antidepressant effects
have yet to be elucidated in human brain functional neuroimaging or in cellular models.
This 3-year proposal is divided into 2 clinical studies. In study 1, the investigators aim
to test the clinical and biological effects of n-3 PUFAs (EPA: 3.5 g/d and DHA: 1.75 g/d
versus placebo: high oleic oil) for depressive symptoms in a 12-week, double-blind,
placebo-controlled trial of patients with drug-free MDD. In study 2, the investigators will
measure the biological and neuroimaging markers to investigate the biological mechanisms of
EPA (3.5 g/d) versus DHA (1.75 g/d) in 12-week, double-blind, randomized-controlled trial
with patients with drug-free major depression disorder (MDD).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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