An interventional study of fish oil capsule and soybean oil capsule in Major Depressive Disorder, sponsored by Second Xiangya Hospital of Central South University. Status unknown at 1 site in China. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-10-10.
Sponsored by Second Xiangya Hospital of Central South University · Not applicable, Interventional, and Treatment
In this proposed study, the investigators will evaluate the effects of fish oil add-on in treatment of major depressive disorder(MDD).
Participants are randomly assigned to two groups (n=60): control (placebo, soybean) and fish oil (containing EPA 1440mg, DHA 960mg). The experimental groups will be compared to placebo to evaluate if it may benefit clinical symptoms, cognitive symptoms and metabolic markers in MDD patients. We also plan to investigate the changes in markers of inflammation at the same time.
Exclusion Criteria:
the experimental group will be given 4 fish oil capsules (1g/one capsule)twice daily after two meals at roughly the same time each day,lasting for the first 6 months.fish oil capsule will be provided by the Hunan Kangqi100 Biological Technology Co.Ltd.
Dietary Supplement: fish oil capsule
the control group will be given 4 soybean oil capsules ( placebo capsule,1g/one capsule) twice daily after two meals at roughly the same time each day,lasting for the first 6 months.placebo capsule will be provided by the Hunan Kangqi100 Biological Technology Co.Ltd.The placebo capsule's appearance and flavor are made the exactly the same as the fish oil capsules .
Dietary Supplement: soybean oil capsule
N-3 PUFAs is a kind of essential fatty acid,however the formation is too slow. Studies show that intakes of N-3 PUFAs is associated with MDD.It have to be got from food like deep-sea fishes. EPA and DHA are crucial for the body.Although studies have shown that reduced N-3 PUFAs were correlated with MDD, and patients with an elevated rate of N-6 PUFAs /N-3 PUFAs or a low level of DHA may be at higher odds for suicide. Trials on whether N-3 PUFAs is effective in the treatment of MDD is still controversial, which might be affected by several factors, such as dose, duration etc.. Now there is no large-scale randomized controlled clinical trial in determining the effects of N-3 PUFAs add-on in treatment of MDD.
placebo capsule
Changes in Hamilton Depression Scale (HAMD) HAMD
Subjects were evaluated for current depression with HAMD.
Time frame: W0 W4 W12 W24 W48
Changes in Clinical Global Impression (CGI)
Subjects were evaluated for current severity of disease with CGI.
Time frame: W0 W4 W12 W24 W48
Changes in Hamilton Anxiety Scale (HAMA)
Subjects were evaluated for current anxiety with HAMA.
Time frame: W0 W4 W12 W24 W48
Changes in Beck Depression Rating Scale (BDI)
The BDI is a self-report inventory of depression symptom.
Time frame: W0 W4 W12 W24 W48
Changes in Self-Rating Anxiety Scale (SAS)
The SAS is a self-report inventory of anxiety symptom.
Time frame: W0 W4 W12 W24 W48
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — June 1,2020, Email to Dr. Chen Jindong(chenjd269@163.com)
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Second Xiangya Hospital of Central South University