Fish Oil as Adjunct Treatment for Major Depressive Disorder

Not Applicable

• Conditions: Major Depressive Disorder

• Registration Number: NCT03295708
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-22
• Study First Posted: 2017-09-28
• Status Verified: 2017-10
• Study Start: 2017-10-01
• Last Update Submitted: 2017-10-06
• Last Update Posted: 2017-10-10
• Primary Completion: 2019-10-01
• Study Completion: 2020-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Hamilton Depression Scale (HAMD) HAMD	W0 W4 W12 W24 W48	Subjects were evaluated for current depression with HAMD.

Secondary Outcome Measures

Name	Time	Method
Changes in Clinical Global Impression (CGI)	W0 W4 W12 W24 W48	Subjects were evaluated for current severity of disease with CGI.
Changes in Hamilton Anxiety Scale (HAMA)	W0 W4 W12 W24 W48	Subjects were evaluated for current anxiety with HAMA.
Changes in Beck Depression Rating Scale (BDI)	W0 W4 W12 W24 W48	The BDI is a self-report inventory of depression symptom.
Changes in Self-Rating Anxiety Scale (SAS)	W0 W4 W12 W24 W48	The SAS is a self-report inventory of anxiety symptom.

Trial Locations

Locations (1)

Mental Health Institute, Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China