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
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Low-dose group
On the basis of conventional standard treatment, apply the Shaoyang harmonizing method--low-dose group: Xiao Chai Hu Granules 10g, twice daily;
|
Xiaochaihu Granules 10 g, orally administered twice daily (BID) for 100 days, in addition to standard post-transplant care.
|
|
アクティブコンパレータ：High-dose group
Xiao Chai Hu Granules 20g, twice daily, dissolved in water,
|
Xiaochaihu Granules 20 g, orally administered twice daily (BID) for 100 days, in addition to standard post-transplant care.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Hospital Anxiety and Depression Scale (HADS) score
時間枠：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.
|
Baseline to Day 100
|
|
Change in Hamilton Depression Rating Scale (HAMD) score
時間枠：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.
|
Baseline to Day 100
|
|
Change in Traditional Chinese Medicine (TCM) syndrome score
時間枠：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.
|
Baseline to Day 100
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Event-Free Survival (EFS)
時間枠：Up to Day 100
|
Time from treatment initiation to the occurrence of any predefined event, including disease progression, relapse, or death from any cause.
|
Up to Day 100
|
|
Incidence of Graft-versus-Host Disease (GVHD)
時間枠：Up to Day 100
|
Incidence of acute or chronic GVHD diagnosed according to standard clinical criteria.
|
Up to Day 100
|
|
Incidence of infections
時間枠：Up to Day 100
|
Occurrence of clinically or microbiologically confirmed infections during the study period.
|
Up to Day 100
|
|
Cytomegalovirus (CMV) and Epstein-Barr virus (EBV) reactivation
時間枠：Up to Day 100
|
Incidence of CMV or EBV reactivation detected by laboratory testing (e.g., PCR).
|
Up to Day 100
|
|
Number of participants with hepatic veno-occlusive disease (VOD) diagnosed according to EBMT criteria
時間枠：Up to Day 100 after transplantation
|
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.
|
Up to Day 100 after transplantation
|
|
Time to neutrophil and platelet engraftment after allo-HSCT
時間枠：Up to Day 100 after transplantation
|
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.
|
Up to Day 100 after transplantation
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。