NCT07608029Not yet recruitingPhase 2
Xiaochaihu Granules for Depression After Allogeneic Hematopoietic Stem Cell Transplantation
A Single-Center, Prospective, Randomized, Parallel-Assignment, Phase II Study Evaluating Two Dose Levels of Xiaochaihu Granules for Depression After Allogeneic Hematopoietic Stem Cell Transplantation
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 3 May 2026
- Start date
- 16 May 2026
- Primary completion date
- 26 Aug 2026
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- NCT number
- NCT07608029
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 46
- From 16 May 2026 to the primary completion date, 26 Aug 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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);
Other illness
- 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.
Lab values
- Renal insufficiency with serum creatinine ≥2.0 mg/dL;
Other
- Refusal to participate in the study;
Who the study is looking for
- 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.
Age in the registry: 14 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.