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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xiongdan Wan group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xiongdan Wan | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huafang LI, MD, PHD | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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Xiongdan Wan is used in patients diagnosed with Major Depressive Disorder.
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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 |