Clinical trial NCT03295708: Fish Oil as Adjunct Treatment for Major Depressive Disorder
Official title: Safety, Effectiveness, and Mechanism of Fish Oil as Adjunct Treatment for Major Depressive Disorder - a 12-month Randomized, Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder,Fish Oil
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: Xiangya Hospital of Central South University
First posted: 2017-09-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Changes in Hamilton Depression Scale (HAMD) HAMD
timeFrame: W0 W4 W12 W24 W48
Secondary outcomes:
measure: Changes in Clinical Global Impression (CGI)
timeFrame: W0 W4 W12 W24 W48
measure: Changes in Hamilton Anxiety Scale (HAMA)
timeFrame: W0 W4 W12 W24 W48
measure: Changes in Beck Depression Rating Scale (BDI)
timeFrame: W0 W4 W12 W24 W48
measure: Changes in Self-Rating Anxiety Scale (SAS)
timeFrame: W0 W4 W12 W24 W48
Other outcomes:
Locations:
city: Changsha
country: China
facility: Mental Health Institute, Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Central South University
name: Jindong Chen, MD
role: STUDY_DIRECTOR
References:
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