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NCT Number: NCT05136365

A Study of Xiongdan Wan Treating Depression

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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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score compared with baseline at the end of study.

    Time frame: 8 weeks

    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 outcomes

  1. Effective treatment

    Time frame: 8 weeks

    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%

  2. Clinical remission rate

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    MADRS reduction ratio is used to evaluate the effectiveness of the treatment and investigators assess the scale at week 1, 2, 4, 8.

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

    Time frame: 8 weeks

    HAMD-17 reduction ratio is used to evaluate the effectiveness of the treatment and investigators assess the scale at week 1, 2, 4, 8.

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

    Time frame: 8 weeks

    The change of HAMA is used to evaluate the effectiveness of the treatment and investigators assess the scale at week 1, 2, 4, 8.

  6. Change in total score of the Clinical Global Impression scale(CGI)

    Time frame: 8 weeks

    The change of CGI is used to evaluate the effectiveness of the treatment and investigators assess the scale at week 1, 2, 4, 8.

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 29, 2021
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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