This is a single-center, prospective, randomized, dose-escalation Phase II clinical study. A total of 46 patients with newly diagnosed depression following allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be enrolled.
Participants will be randomly assigned to receive different doses of Xiaochaihu Granules in addition to standard post-transplant care for 100 days. The primary objective is to evaluate the efficacy of Xiaochaihu Granules in improving depressive symptoms. Secondary objectives include assessment of safety and clinical outcomes such as event-free survival (EFS), graft-versus-host disease (GVHD), infections, and other transplantation-related complications.
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);
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;
Parallel
Xiaochaihu Granules (Low Dose)
DrugXiaochaihu Granules 10 g, orally administered twice daily (BID) for 100 days, in addition to standard post-transplant care.
Xiaochaihu Granules (High Dose)
DrugXiaochaihu Granules 20 g, orally administered twice daily (BID) for 100 days, in addition to standard post-transplant care.
Change in Hospital Anxiety and Depression Scale (HADS) score
Change in HADS total score from baseline to Day 100. The HADS is a validated self-reported scale ranging from 0 to 42, with higher scores indicating more severe anxiety and depression symptoms.
Change in Hamilton Depression Rating Scale (HAMD) score
Change in HAMD score from baseline to Day 100. The HAMD is a clinician-administered scale assessing depression severity, with higher scores indicating more severe depressive symptoms.
Change in Traditional Chinese Medicine (TCM) syndrome score
Change in TCM syndrome score based on a standardized scoring system evaluating symptoms such as appetite, mood, sleep, and somatic complaints. Higher scores indicate more severe syndrome manifestations.
Event-Free Survival (EFS)
Time from treatment initiation to the occurrence of any predefined event, including disease progression, relapse, or death from any cause.
Incidence of Graft-versus-Host Disease (GVHD)
Incidence of acute or chronic GVHD diagnosed according to standard clinical criteria.
Incidence of infections
Occurrence of clinically or microbiologically confirmed infections during the study period.
Cytomegalovirus (CMV) and Epstein-Barr virus (EBV) reactivation
Incidence of CMV or EBV reactivation detected by laboratory testing (e.g., PCR).
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