A Study of Xiongdan Wan Treating Depression

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05136365
• Other study ID #: SHXD2021CR2103B
• Status: Completed
• Phase: Phase 2
• Start date: December 28, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: April 2024
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Xiongdan Wan
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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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