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A Study of Xiongdan Wan Treating Depression

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Xiongdan Wan
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. Outpatients.
  3. Male or female subjects aged 18-65 years.
  4. HAMD-17 score of the baseline period and screening period is 18-24.
  5. Women of childbearing potential must be willing to use acceptable methods of contraception throughout the study period and the following one month.
  6. The patient fully understands and signs the informed consent form.

Exclusion Criteria:

  1. Patient has survived a suicide attempt or has acute suicidal tendencies (HAMD-17 Item3 ≥3).
  2. Comorbidity according to DSM-IV-TR, axis-I except for major depressive disorder.
  3. HAMD-17 reduction ratio ≥25% within one week from the screening to the baseline period.
  4. Depressive episode secondary to psychiatric illness or somatic disease.
  5. Serious and unstable diseases such as cerebrovascular disease; liver and kidney disease; disease of internal secretion (abnormal thyroid function); hemopathy; seizures, or other encephalopathies.
  6. History of alcohol or drug abuse over the last 6 months.
  7. Allergic history to Xiongdan Wan, or serious drug allergic history.
  8. Pregnant or lactating women and women of childbearing potential throughout the study period; men who have the desire of fertility within six months.
  9. 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.
  10. Treatment with modified electroconvulsive therapy (MECT) or repetitive transcranial magnetic stimulation (rTMS) in the past three months.
  11. Treatment with a systematic psychological treatment in the past three months.

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Xiongdan Wan group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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%
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.
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.
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.
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.
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.

Full Information

First Posted
November 23, 2021
Last Updated
February 7, 2022
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05136365
Brief Title
A Study of Xiongdan Wan Treating Depression
Official Title
The Efficacy and Safety of Xiongdan Wan on Patients With Major Depressive Disorder : a Single-arm, Non-randomized, Open-label Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Xiongdan Wan is used in patients diagnosed with Major Depressive Disorder.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xiongdan Wan group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Xiongdan Wan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score compared with baseline at the end of study.
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Effective treatment
Description
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%
Time Frame
8 weeks
Title
Clinical remission rate
Description
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.
Time Frame
8 weeks
Title
The Montgomery-Asberg Depression Rating Scale (MADRS) reduction ratio
Description
MADRS reduction ratio is used to evaluate the effectiveness of the treatment and investigators assess the scale at week 1, 2, 4, 8.
Time Frame
8 weeks
Title
The Hamilton Depression Rating Scale (HAMD-17) reduction ratio
Description
HAMD-17 reduction ratio is used to evaluate the effectiveness of the treatment and investigators assess the scale at week 1, 2, 4, 8.
Time Frame
8 weeks
Title
Change in the total score of the Hamilton Anxiety Scale(HAMA)
Description
The change of HAMA is used to evaluate the effectiveness of the treatment and investigators assess the scale at week 1, 2, 4, 8.
Time Frame
8 weeks
Title
Change in total score of the Clinical Global Impression scale(CGI)
Description
The change of CGI is used to evaluate the effectiveness of the treatment and investigators assess the scale at week 1, 2, 4, 8.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huafang LI, MD, PHD
Phone
86-21-34773128
Email
lhlh_5@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huafang LI, MD, PHD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huafang Li, MD, PHD
Phone
86-2134773128
Email
lhlh_5@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study of Xiongdan Wan Treating Depression

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