A Study of Xiongdan Wan Treating Depression

Study Overview
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Brief Summary
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This is a prospective, single-arm, open-label study to evaluate the safety and efficacy of Xiongdan Wan monotherapy in patients with Major Depressive Disorder(MDD), conducted in Shang Hai Mental Health Center. Following a screening period, subjects who meet the entry criteria will be treated with 450mg Xiongdan Wan pills three times daily for 8 weeks.

Official Title
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The Efficacy and Safety of Xiongdan Wan on Patients With Major Depressive Disorder : a Single-arm, Non-randomized, Open-label Trial

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Xiongdan Wan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD): a single or recurrent episode without psychotic features. Codes are as follows: F32.0, F32.1, F32.2, F33.0, F33.1, F33.2. Outpatients. Male or female subjects aged 18-65 years. HAMD-17 score of the baseline period and screening period is 18-24. Women of childbearing potential must be willing to use acceptable methods of contraception throughout the study period and the following one month. The patient fully understands and signs the informed consent form. Exclusion Criteria: Patient has survived a suicide attempt or has acute suicidal tendencies (HAMD-17 Item3 ≥3). Comorbidity according to DSM-IV-TR, axis-I except for major depressive disorder. HAMD-17 reduction ratio ≥25% within one week from the screening to the baseline period. Depressive episode secondary to psychiatric illness or somatic disease. Serious and unstable diseases such as cerebrovascular disease; liver and kidney disease; disease of internal secretion (abnormal thyroid function); hemopathy; seizures, or other encephalopathies. History of alcohol or drug abuse over the last 6 months. Allergic history to Xiongdan Wan, or serious drug allergic history. Pregnant or lactating women and women of childbearing potential throughout the study period; men who have the desire of fertility within six months. Clinically significant changes in ECG or laboratory tests, including >1.5 times the upper limit of normal liver function; over the limit of normal renal function and blood sugar; abnormal cardiac troponins; obvious abnormity in the thyroid function. Treatment with modified electroconvulsive therapy (MECT) or repetitive transcranial magnetic stimulation (rTMS) in the past three months. Treatment with a systematic psychological treatment in the past three months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Xiongdan Wan is used in patients diagnosed with Major Depressive Disorder.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xiongdan Wan group<br>Xiongdan Wan is used in patients diagnosed with Major Depressive Disorder. The daily dose (1350mg per day) should be strictly controlled according to the experimental design. | Drug: Xiongdan Wan<br>* Xiongdan Wan is used as 450mg three times a day after meals with water for 8 weeks. The daily dose (e.g. 450mg/bag, 3 times/day) should be strictly controlled according to the experimental design. Patients should take medicine regularly every day under the guidance of doctors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score compared with baseline at the end of study. | The main objective is to explore whether Xiongdan Wan improve the MDD symptoms after 8 weeks of treatment, and investigators assess the scale at week 1, 2, 4, 8. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective treatment | Montgomery-Asberg Depression Rating Scale (MADRS) or Hamilton Depression Rating Scale （HAMD-17）reduction ratio ≥50% reductive ratio [（Baseline score- Endpoint score）／Baseline score]×100% | 8 weeks | 
| Clinical remission rate | Patients in remission at the end of the study will be summarized, Montgomery-Asberg Depression Rating Scale (MADRS) score ≤12 or Hamilton Depression Rating Scale （HAMD-17）≤7. | 8 weeks | 
| The Montgomery-Asberg Depression Rating Scale (MADRS) reduction ratio | MADRS reduction ratio is used to evaluate the effectiveness of the treatment and investigators assess the scale at week 1, 2, 4, 8. | 8 weeks | 
| The Hamilton Depression Rating Scale (HAMD-17) reduction ratio | HAMD-17 reduction ratio is used to evaluate the effectiveness of the treatment and investigators assess the scale at week 1, 2, 4, 8. | 8 weeks | 
| Change in the total score of the Hamilton Anxiety Scale(HAMA) | The change of HAMA is used to evaluate the effectiveness of the treatment and investigators assess the scale at week 1, 2, 4, 8. | 8 weeks | 
| Change in total score of the Clinical Global Impression scale(CGI) | The change of CGI is used to evaluate the effectiveness of the treatment and investigators assess the scale at week 1, 2, 4, 8. | 8 weeks |