Skip to content

Study the anti-depressant effect and mechanism of Si-Mo decoction based on the effect of tryptophan microbiota metabolites on neuroglial immune homeostasis

Study the anti-depressant effect and mechanism of Si-Mo decoction based on the effect of tryptophan microbiota metabolites on neuroglial immune homeostasis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001300
Enrollment
Unknown
Registered
2025-06-30
Start date
2023-10-24
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Depression

Interventions

SSRI plus Si-Mo decoction treatment group:In addition to SSRI pharmacotherapy, Simo Decoction Oral Liquid was administered at a dose of 10 mL per dose (specification: 10 mL per ampoule
Hunan Hansheng Pharmaceutical Co., Ltd.), three times daily for 28 consecutive days.
SSRI treatment group:Antidepressant medication (SSRI) was administered based on the physician's diagnosis with dosage and administration following the prescribing physician's instructions.
MDD (major depression disorder) control:None
Healthy control:None

Sponsors

Affiliated Guangji Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Healthy Volunteers: 1)Aged 18-65 years with a clinically unremarkable physical examination.2)Hamilton Depression Rating Scale (HAMD-17) score = 7 Montgomery-Åsberg Depression Rating Scale (MADRS) score = 10 and no prior clinical diagnosis of depression or other psychiatric disorders. Inclusion Criteria for Volunteers with Depression:1)Diagnosis of depressive disorder according to the International Classification of Diseases (ICD-10) with no comorbid psychiatric disorders.2)Informed consent obtained and signed by the patient or their legal guardian prior to enrollment.3)Aged 18-65 years with a clinically unremarkable physical examination.

Exclusion criteria

Exclusion criteria: Exclusion Criteria for Volunteers with Depression: 1)Presence of severe physical illness.2)Drug or alcohol dependence or abuse.3)Other depressive disorders such as bipolar depression or post-schizophrenic depression.4)Patients who have undergone Modified Electroconvulsive Therapy (MECT) within the past 6 months.5)Women who are pregnant or breastfeeding.6)Patients diagnosed with treatment-resistant depression (TRD) or exhibiting severe suicidal tendencies defined as a score =3 on item 3 ("Suicide") of the HAMD-17 scale.Patients who have received systematic psychotherapy (e.g. Cognitive Behavioral Therapy Psychodynamic Therapy) or physical therapy (e.g. 7)Transcranial Magnetic Stimulation (TMS) Vagus Nerve Stimulation (VNS)) within the 3 months prior to enrollment. 8)Patients unable to adhere to medication schedules or with poor compliance.

Design outcomes

Primary

MeasureTime frame
Degree of depression;

Countries

China

Contacts

Public ContactPan ShuMan

Affiliated Guangji Hospital of Soochow University

pythime5678@suda.edu.cn+86 152 9836 6959

Outcome results

None listed

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