Xiaochaihu Granules for Depression After Allogeneic Hematopoietic Stem Cell Transplantation

Korábbi kezelés

• Current use of other antidepressant medications;
• Significant cardiovascular conditions, including:
  • Unstable angina; Acute myocardial infarction within 6 months prior to enrollment; NYHA class III-IV heart failure; Circulatory failure requiring vasoactive or inotropic support; Clinically significant arrhythmia requiring treatment;
• Participation in another interventional clinical trial within 21 days prior to enrollment (or within 5 half-lives of the investigational product, whichever is longer);

Más betegség

• Presence of severe psychiatric disorders or severe somatic symptom disorders;
• Known allergy to Xiaochaihu Granules or any of its components;
• Severe organ dysfunction or unstable clinical condition, including but not limited to:
  • Uncontrolled bloodstream infection; Expected survival <3 months;
• History of splenectomy;
• Cholestatic liver disease or unresolved hepatic veno-occlusive disease (VOD);
• Severe respiratory disease requiring mechanical ventilation or ≥50% oxygen support;
• Patients whose primary disease is in complete remission after transplantation (per protocol definition);
• Any other condition deemed by the investigator to make the patient unsuitable for participation.

Laborértékek

• Renal insufficiency with serum creatinine ≥2.0 mg/dL;

Egyéb

• Refusal to participate in the study;

• Participants must meet all of the following criteria:
  • Able to understand the study procedures and voluntarily provide written informed consent (or consent from a legal guardian where applicable);
  • Age ≥14 years, male or female;
  • Patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT);
  • Newly diagnosed depression after allo-HSCT, assessed by standardized scales (e.g., HADS and/or HAMD);
  • Evidence of successful neutrophil engraftment prior to enrollment;
  • Willing and able to comply with study procedures and follow-up assessments.