Xiaochaihu Granules for Depression After Allogeneic Hematopoietic Stem Cell Transplantation

NCT07608029 | Not Yet Recruiting Phase 2

• 1 other identifier: OMD-HSCT-20250902
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Depressive Disorder, Secondary; Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline to Day 100

• 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.

  Baseline to Day 100

• 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.

  Baseline to Day 100

Secondary Outcomes (6)

• Event-Free Survival (EFS)

  Up to Day 100

• Incidence of Graft-versus-Host Disease (GVHD)

  Up to Day 100

• Incidence of infections

  Up to Day 100

• Cytomegalovirus (CMV) and Epstein-Barr virus (EBV) reactivation

  Up to Day 100

• Number of participants with hepatic veno-occlusive disease (VOD) diagnosed according to EBMT criteria

  Up to Day 100 after transplantation

Study Arms (2)

Low-dose group

EXPERIMENTAL

On the basis of conventional standard treatment, apply the Shaoyang harmonizing method--low-dose group: Xiao Chai Hu Granules 10g, twice daily;

Drug: Xiaochaihu Granules (Low Dose)

High-dose group

ACTIVE COMPARATOR

Xiao Chai Hu Granules 20g, twice daily, dissolved in water,

Drug: Xiaochaihu Granules (High Dose)

Interventions

Xiaochaihu Granules (Low Dose) DRUG

Xiaochaihu Granules 10 g, orally administered twice daily (BID) for 100 days, in addition to standard post-transplant care.

Low-dose group

Xiaochaihu Granules (High Dose) DRUG

Xiaochaihu Granules 20 g, orally administered twice daily (BID) for 100 days, in addition to standard post-transplant care.

High-dose group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

MeSH Terms

Conditions

Depressive Disorder; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 27, 2026
• Study Start: May 16, 2026
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): September 30, 2029
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share