Major Depressive Disorder
Conditions
Keywords
Major depressive disorder,Fish Oil
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.
Interventions
DIETARY_SUPPLEMENTfish 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.
DIETARY_SUPPLEMENTsoybean oil capsule
placebo capsule
Sponsors
Xiangya Hospital of Central South University
Second Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Hamilton Depression Scale (HAMD) HAMD | W0 W4 W12 W24 W48 | Subjects were evaluated for current depression with HAMD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactLu Wang, MD
Backup ContactMimi Tang, MD
Outcome results
None listed