Phospholipid Hypothesis of Depression: From Molecular Biology, Neuroimaging to Behaviour
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|ClinicalTrials.gov Identifier: NCT02615405|
Recruitment Status : Completed
First Posted : November 26, 2015
Last Update Posted : November 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Dietary Supplement: EPA Dietary Supplement: DHA Dietary Supplement: Placebo||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
3.5 g/day in Studies 1 & 2
Dietary Supplement: EPA
A daily treatment of 5 identical capsules of EPA (3.5 g/d) for Studies 1 & 2.
Other Name: Fish oil EPA
Active Comparator: DHA
1.75 g/day in Studies 1 & 2
Dietary Supplement: DHA
A daily treatment of 5 identical capsules of DHA (1.75 g/d) for Studies 1 & 2.
Other Name: Fish oil DHA
Placebo Comparator: Placebo capsules
oleic oil in Study 1
Dietary Supplement: Placebo
A daily treatment of 5 identical capsules of placebo (high oleic oil) in single or divided administration for Study 1.
Other Name: oleic oil
- Changes from Baseline Hamilton Depression Rating Scale (HDRS) at 12 weeks [ Time Frame: Week 12 ]
- Remission rate [ Time Frame: Week 12 ]
- Response rate [ Time Frame: Week 12 ]
- Changes in Beck Depression Inventory (BDI) [ Time Frame: Week 12 ]
- Changes in Neurotoxicity Rating Scale (NRS) [ Time Frame: Week 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615405
|China Medical University Hospital|
|Taichung, Taiwan, 403|
|Principal Investigator:||Kuan-Pin Su, MD PhD||China Medical University Hospital|