Fish Oil as Adjunct Treatment for Major Depressive Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03295708|
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : October 10, 2017
|Condition or disease||Intervention/treatment|
|Major Depressive Disorder||Dietary Supplement: fish oil capsule Dietary Supplement: soybean oil capsule|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Safety, Effectiveness, and Mechanism of Fish Oil as Adjunct Treatment for Major Depressive Disorder - a 12-month Randomized, Placebo Controlled Clinical Trial|
|Actual Study Start Date :||October 1, 2017|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||April 1, 2020|
Experimental: experimental group
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
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 Comparator: control group
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
- Changes in Hamilton Depression Scale (HAMD) HAMD [ Time Frame: W0 W4 W12 W24 W48 ]Subjects were evaluated for current depression with HAMD.
- Changes in Clinical Global Impression (CGI) [ Time Frame: W0 W4 W12 W24 W48 ]Subjects were evaluated for current severity of disease with CGI.
- Changes in Hamilton Anxiety Scale (HAMA) [ Time Frame: W0 W4 W12 W24 W48 ]Subjects were evaluated for current anxiety with HAMA.
- Changes in Beck Depression Rating Scale (BDI) [ Time Frame: W0 W4 W12 W24 W48 ]The BDI is a self-report inventory of depression symptom.
- Changes in Self-Rating Anxiety Scale (SAS) [ Time Frame: W0 W4 W12 W24 W48 ]The SAS is a self-report inventory of anxiety symptom.
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): NCT03295708
|Contact: Lu Wang, MDfirstname.lastname@example.org|
|Contact: Mimi Tang, MDemail@example.com|
|Mental Health Institute, Second Xiangya Hospital of Central South University||Recruiting|
|Changsha, Hunan, China, 410000|
|Contact: Lu Wang, M.D. +8615116331768 firstname.lastname@example.org|
|Contact: Mi Mi Tang, M.D. +8617136372000 email@example.com|
|Study Director:||Jindong Chen, MD||Central South University|