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COMPLETEDPHASE2

A Study of Xiongdan Wan Treating Depression

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

NCT05136365•Shanghai Mental Health Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

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.
+1 more criteria

Locations (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

December 28, 2021

Primary Completion Date

August 30, 2022

Completion Date

August 30, 2022

Last Updated

April 18, 2024

Enrollment

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

Xiongdan Wan

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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A Study of Xiongdan Wan Treating Depression

Inclusion Criteria

Exclusion Criteria

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