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Safety, effectiveness, and mechanism of fish oil as adjunct treatment for Major Depressive Disorder - a 12-month randomized, placebo controlled clinical trial

Safety, effectiveness, and mechanism of N-3 polyunsaturated fatty acids (N-3 PUFAs) as adjunct treatment for Major Depressive Disorder - a 12-month randomized, placebo controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17012697
Enrollment
Unknown
Registered
2017-09-18
Start date
2017-10-01
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depressive disorder

Interventions

B group:B capsule
A group:A capsule

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. TAble 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

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

MeasureTime frame
HAMD;HAMA;BDI;SAS;

Countries

China

Contacts

Public ContactJindong Chen

The Second Xiangya Hospital of Central South University

chenjd269@163.com+86 13807319266

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026