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A Study on the Clinical Efficacy and Brain Functional Mechanism of Shuyi San in the Treatment of Depression with Anhedonic Depression: Focusing on the Regulation of the Nrf2/GPX4/Ferroptosis Axis

A Study on the Clinical Efficacy and Brain Functional Mechanism of Shuyi San in the Treatment of Depression with Anhedonic Depression: Focusing on the Regulation of the Nrf2/GPX4/Ferroptosis Axis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002190
Enrollment
Unknown
Registered
2025-11-17
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Anhedonic Depression

Interventions

Fluoxetine group:Fluoxetine Hydrochloride Specifications and Administration: Manufactured by Eli Lilly and Company, USA. Specifications: 20mg*28 capsules. Dosage: 20mg per day. Take it half an hour af
Shuyi SAN + fluoxetine Group:The composition and administration of Shuyi SAN: Morinda officinalis 15g Curculigo orchioides 6g Atractylodes macrocephala 15g Astragalus membranaceus 15g Pinellia ternata
Healthy control group:No intervention

Sponsors

Linyi Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Age between 18 and 60 years old;2) Right-handed; 3) Meeting the diagnostic criteria of DSM-5 for major depressive disorder with melancholic features and the diagnostic criteria of Traditional Chinese Medicine; 4) Current disease course (last episode) of at least 2 weeks;5) HAMD-24 score=18; Snith-Hamilton Pleasure Scale (SHAPS) score=3; 6) No antidepressant use within the last half month before enrollment; 7) No electroconvulsive therapy within the last half year before enrollment; 8) Head circumference: 52 - 60 cm.Healthy control group: 1) Age ranging from 18 to 60 years old; 2) HAMD-24 score < 8 points SHAPS < 3 points; 3) No severe physical illness no history of mental illness alcohol or drug abuse; 4) Head circumference: 52 - 60 cm.

Exclusion criteria

Exclusion criteria: 1) Coexisting with another mental disorder; 2) History of alcohol or drug dependence or smoking more than 10 cigarettes per day; 3) Severe physical diseases of the heart, liver, kidneys, brain and hematopoietic system, central nervous system infection, head injury, epilepsy, multiple sclerosis, toxic metabolic diseases, Parkinson's disease or intracranial tumors; 4) Family history of hereditary diseases; 5) Endocrine system diseases such as diabetes, hyperthyroidism or hypothyroidism; 6) Pregnant or lactating women or those with photosensitivity. Healthy control group: 1) Those with a family history of mental illness within two generations; 2) Pregnant or lactating women or those with photosensitivity.

Design outcomes

Secondary

MeasureTime frame
Nrf2/glutathione peroxidase 4 in the blood;TCM Syndrome Assessment Scale;Indicators of brain activation and indicators of brain network connectivity;

Primary

MeasureTime frame
Hamilton Depression Scale 24-item,HAMD-24;Snaith-Hamilton Pleasure Scale,SHAPS;

Countries

China

Contacts

Public ContactXiaoxi Liu

Linyi Central Hospital

182533430@qq.com18866907060

Outcome results

None listed

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