Depressive Disorder, SecondaryPhase 2NCT07608029

Xiaochaihu Granules for Depression After Allogeneic Hematopoietic Stem Cell Transplantation

A Phase 2 study testing Xiaochaihu Granules (Low Dose) and Xiaochaihu Granules (High Dose) in people with Depressive Disorder, Secondary and Hematopoietic Stem Cell Transplantation, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 14 years and older
Conditions the study is for: Depressive Disorder, Secondary, Hematopoietic Stem Cell Transplantation
What is being tested?: Xiaochaihu Granules (Low Dose) and Xiaochaihu Granules (High Dose)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: No sites listed yet
Study dates: 16 May 2026to 30 Sep 2029
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 15Show fewer

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.

About this study

Official title: 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

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.

Read the detailed description

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.

Conditions: Depressive Disorder, Secondary, Hematopoietic Stem Cell Transplantation
Being tested: Xiaochaihu Granules (Low Dose), Xiaochaihu Granules (High Dose)
Medical subject headings: Depressive Disorder, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Xiaochaihu Granules (Low Dose)Drug
Xiaochaihu Granules 10 g, orally administered twice daily (BID) for 100 days, in addition to standard post-transplant care.
Xiaochaihu Granules (High Dose)Drug
Xiaochaihu Granules 20 g, orally administered twice daily (BID) for 100 days, in addition to standard post-transplant care.

Study groups in NCT07608029
Study group	Role	What they receive
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; Receives: Drug: Xiaochaihu Granules (Low Dose)
High-dose group	Active comparator	Xiao Chai Hu Granules 20g, twice daily, dissolved in water, Receives: Drug: Xiaochaihu Granules (High Dose)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Baseline to Day 100

Secondary outcomes (6)

Event-Free Survival (EFS)
Time from treatment initiation to the occurrence of any predefined event, including disease progression, relapse, or death from any cause.
Measured: Up to Day 100
Incidence of Graft-versus-Host Disease (GVHD)
Incidence of acute or chronic GVHD diagnosed according to standard clinical criteria.
Measured: Up to Day 100
Incidence of infections
Occurrence of clinically or microbiologically confirmed infections during the study period.
Measured: Up to Day 100
Cytomegalovirus (CMV) and Epstein-Barr virus (EBV) reactivation
Incidence of CMV or EBV reactivation detected by laboratory testing (e.g., PCR).
Measured: Up to Day 100
Number of participants with hepatic veno-occlusive disease (VOD) diagnosed according to EBMT criteria
The number of participants who develop hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) after allo-HSCT, diagnosed according to the European Society for Blood and Marrow Transplantation (EBMT) clinical criteria, including bilirubin elevation, weight gain, hepatomegaly, ascites, or related clinical findings.
Measured: Up to Day 100 after transplantation
Time to neutrophil and platelet engraftment after allo-HSCT
Neutrophil engraftment is defined as the first of 3 consecutive days with an absolute neutrophil count (ANC) ≥ 0.5 × 10^9/L without growth factor support. Platelet engraftment is defined as the first of 7 consecutive days with platelet count ≥ 20 × 10^9/L without platelet transfusion support. Time to engraftment will be calculated from transplantation to the date of engraftment.
Measured: Up to Day 100 after transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 May 202630 Sep 2029

First posted27 May 2026
Study start16 May 2026 (estimated)
Primary completion26 Aug 2026 (estimated)
Study completion30 Sep 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Depressive Disorder, SecondaryStudies of the same condition, open and under way.
More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 46 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07608029
Sponsor's protocol ID: OMD-HSCT-20250902
Status last verified: May 2026
First submitted: 3 May 2026
Last updated: 27 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07608029
Acronym / sponsor ID: OMD-HSCT-20250902
Conditions: Depressive Disorder, Secondary, Hematopoietic Stem Cell Transplantation
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 46 participants (estimated)
Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
Study start: 16 May 2026 (estimated)
Primary completion: 26 Aug 2026 (estimated)
Study completion: 30 Sep 2029 (estimated)
First posted: 27 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Low-dose group	Experimental	Drug: Xiaochaihu Granules (Low Dose)On the basis of conventional standard treatment, apply the Shaoyang harmonizing method--low-dose group: Xiao Chai Hu Granules 10g, twice daily;
High-dose group	Active comparator	Drug: Xiaochaihu Granules (High Dose)Xiao Chai Hu Granules 20g, twice daily, dissolved in water,

Who may qualify

Ages: 14 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Participants must meet all of the following criteria:

Key exclusion criteria (15 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Xiaochaihu Granules (Low Dose)Xiaochaihu Granules 10 g, orally administered twice daily (BID) for 100 days, in addition to standard post-transplant care.	Drug	Low-dose group
Xiaochaihu Granules (High Dose)Xiaochaihu Granules 20 g, orally administered twice daily (BID) for 100 days, in addition to standard post-transplant care.	Drug	High-dose group

Primary outcome

Change in Hospital Anxiety and Depression Scale (HADS) score
Time frame: Baseline to Day 100
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
Time frame: Baseline to Day 100
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
Time frame: Baseline to Day 100
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.

6 secondary outcomes

Event-Free Survival (EFS)
Time frame: Up to Day 100
Incidence of Graft-versus-Host Disease (GVHD)
Time frame: Up to Day 100
Incidence of infections
Time frame: Up to Day 100
Cytomegalovirus (CMV) and Epstein-Barr virus (EBV) reactivation
Time frame: Up to Day 100
Number of participants with hepatic veno-occlusive disease (VOD) diagnosed according to EBMT criteria
Time frame: Up to Day 100 after transplantation
Time to neutrophil and platelet engraftment after allo-HSCT
Time frame: Up to Day 100 after transplantation

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
Individual participant dataSharing planned: No

Related trials for Depressive Disorder, Secondary

Active, not recruiting
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Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or Incurable Hematologic Malignancies
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RecruitingPhase 2
Bright White Light Therapy in Reducing Cancer-Related Fatigue and Depression in Advanced Prostate Cancer Patients Undergoing Treatment With ADT Combination Therapy
Advanced Prostate Carcinoma, Metastatic Prostate Carcinoma
Recruiting
Evaluation of a Remote Behavioural Stress Recovery Intervention for Myocardial Infarction Patients Younger Than Fifty-five (BRIM-55): A Feasibility Study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hospital Anxiety and Depression Scale (HADS) score (time frame: Baseline to Day 100). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07608029.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.