Clinical trial NCT05136365: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Xiongdan Wan is used in patients diagnosed with Major Depressive Disorder.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score compared with baseline at the end of study.
timeFrame: 8 weeks
Secondary outcomes:
measure: Effective treatment
timeFrame: 8 weeks
measure: Clinical remission rate
timeFrame: 8 weeks
measure: The Montgomery-Asberg Depression Rating Scale (MADRS) reduction ratio
timeFrame: 8 weeks
measure: The Hamilton Depression Rating Scale (HAMD-17) reduction ratio
timeFrame: 8 weeks
measure: Change in the total score of the Hamilton Anxiety Scale(HAMA)
timeFrame: 8 weeks
measure: Change in total score of the Clinical Global Impression scale(CGI)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Huafang LI, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: