ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 24 of 1855 for:    "Depressive Disorder" [DISEASE] | "Depressive Disorder, Major"

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
Sponsor:
Collaborator:
Xiangya Hospital of Central South University
Information provided by (Responsible Party):
Jin-Dong Chen, Second Xiangya Hospital of Central South University

Brief Summary:
In this proposed study, the investigators will evaluate the effects of fish oil add-on in treatment of major depressive disorder(MDD).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Dietary Supplement: fish oil capsule Dietary Supplement: soybean oil capsule Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
placebo capsule




Primary Outcome Measures :
  1. Changes in Hamilton Depression Scale (HAMD) HAMD [ Time Frame: W0 W4 W12 W24 W48 ]
    Subjects were evaluated for current depression with HAMD.


Secondary Outcome Measures :
  1. Changes in Clinical Global Impression (CGI) [ Time Frame: W0 W4 W12 W24 W48 ]
    Subjects were evaluated for current severity of disease with CGI.

  2. Changes in Hamilton Anxiety Scale (HAMA) [ Time Frame: W0 W4 W12 W24 W48 ]
    Subjects were evaluated for current anxiety with HAMA.

  3. Changes in Beck Depression Rating Scale (BDI) [ Time Frame: W0 W4 W12 W24 W48 ]
    The BDI is a self-report inventory of depression symptom.

  4. Changes in Self-Rating Anxiety Scale (SAS) [ Time Frame: W0 W4 W12 W24 W48 ]
    The SAS is a self-report inventory of anxiety symptom.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to provide informed consent
  2. Men or women aged 18-50 years
  3. A primary psychiatric diagnosis of major depressive disorder (MDD), by Diagnostic and Statistical Manual-5th ed (DSM-5) using the MINI
  4. HAMD total score≥21
  5. No significantly modification of their diet from the time they sign consent to the end of study participation

Exclusion Criteria:

  1. Suffering from other serious somatic diseases or comorbidities
  2. Patients with serious nervous system disease
  3. Patients in accordance with diagnostic standards of other mental illness
  4. Patients who need to take benzodiazepine every day, and who currently need to be treated by electroconvulsive therapy or have received electroconvulsive therapy in the past 6 months
  5. Pregnant women or lactating women, women with pregnancy plans during the trial period (12 months), women with a high risk of pregnancy but without taking any contraceptive measures
  6. Patients with apparent suicide attempt or suicidal behavior
  7. Any condition or medicines that may have an effect on biomarkers (within 1 week of the screening period or during whole trial period): long-term, regular use of NSAIDs, COX-2 inhibitors, immunosuppressant, steroids, interferon, chemotherapeutics, anticoagulants, malignancy, active autoimmune diseases, inflammatory bowel diseases, etc
  8. Allergy history of PUFA
  9. Intake of Fish oil more than 3g per day or eat fatty fish more than 3 times a week

Information from the National Library of Medicine

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


Contacts
Contact: Lu Wang, MD +8615116331768 luwang112@163.com
Contact: Mimi Tang, MD +8615802607545 tangmimi1989@163.com

Locations
China, Hunan
Mental Health Institute, Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410000
Contact: Lu Wang, M.D.    +8615116331768    luwang112@163.com   
Contact: Mi Mi Tang, M.D.    +8617136372000    tangmimi1989@163.com   
Sponsors and Collaborators
Second Xiangya Hospital of Central South University
Xiangya Hospital of Central South University
Investigators
Study Director: Jindong Chen, MD Central South University
  Study Documents (Full-Text)

Documents provided by Jin-Dong Chen, Second Xiangya Hospital of Central South University:

Publications:

Responsible Party: Jin-Dong Chen, Director of Mental Health Institute of the Second Xiangya Hospital, Second Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03295708     History of Changes
Other Study ID Numbers: MDD201610
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: June 1,2020, Email to Dr. Chen Jindong(chenjd269@163.com)

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jin-Dong Chen, Second Xiangya Hospital of Central South University:
Major depressive disorder,Fish Oil

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms