Xiaochaihu Granules for Depression After Allogeneic Hematopoietic Stem Cell Transplantation

This is a single-center, prospective, randomized, dose-escalation Phase II clinical trial designed to evaluate the efficacy and safety of Xiaochaihu Granules in patients with depression following allogeneic hematopoietic stem cell transplantation (allo-HSCT).

A total of 46 eligible patients with newly diagnosed depression after allo-HSCT will be enrolled. Participants will be randomly assigned to receive either a low-dose or high-dose regimen of Xiaochaihu Granules, administered orally twice daily for 100 days, in addition to standard post-transplant care.

The primary endpoints include changes in depression severity as assessed by validated scales (e.g., HADS and HAMD) and changes in symptom burden. Secondary endpoints include event-free survival (EFS), incidence of graft-versus-host disease (GVHD), infections, viral reactivation, engraftment outcomes, and overall safety.

Inclusion criteria

• 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.

Exclusion criteria

• Refusal to participate in the study;
• Presence of severe psychiatric disorders or severe somatic symptom disorders;
• Known allergy to Xiaochaihu Granules or any of its components;
• Current use of other antidepressant medications;
• Severe organ dysfunction or unstable clinical condition, including but not limited to:

Uncontrolled bloodstream infection; Expected survival <3 months;

• History of splenectomy;
• Renal insufficiency with serum creatinine ≥2.0 mg/dL;
• Cholestatic liver disease or unresolved hepatic veno-occlusive disease (VOD);
• 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;

• Severe respiratory disease requiring mechanical ventilation or ≥50% oxygen support;
• Patients whose primary disease is in complete remission after transplantation (per protocol definition);
• Participation in another interventional clinical trial within 21 days prior to enrollment (or within 5 half-lives of the investigational product, whichever is longer);
• Any other condition deemed by the investigator to make the patient unsuitable for participation.