A Study of Xiongdan Wan Treating Depression

NCT05136365 | Completed Phase 2 DMC

• 1 other identifier: SHXD2021CR2103B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Effective treatment

  8 weeks

• Clinical remission rate

  8 weeks

• The Montgomery-Asberg Depression Rating Scale (MADRS) reduction ratio

  8 weeks

• The Hamilton Depression Rating Scale (HAMD-17) reduction ratio

  8 weeks

• Change in the total score of the Hamilton Anxiety Scale(HAMA)

  8 weeks

Study Arms (1)

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.

Drug: Xiongdan Wan

Interventions

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.

Xiongdan Wan group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Huafang LI, MD, PHD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director of MICT

Model Details: Xiongdan Wan is used in patients diagnosed with Major Depressive Disorder.

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: November 29, 2021
• Study Start: December 28, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)