Status:
UNKNOWN
Bear Bile Pill as add-on the Treatment of MDD
Lead Sponsor:
Shanghai Mental Health Center
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a single-center, double blind, randomized, placebo-controlled, parallel group study of bear bile pill, as add-on therapy in MDD patients conducted in Shang Hai Mental Health Center. The purpos...
Eligibility Criteria
Inclusion
- Meets the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition, Text Revision (DSM-V) 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 or inpatients.
- Male or female subjects aged 18-65 years.
- Patients have got standard treatment of SSRI/SNRI monotherapy for more than 4 weeks in current episode of depression before trial entry.
- MADRS score greater than 20.
- Women of childbearing potential must be willing to use acceptable methods of contraception throughout the study period and the following one month.
- The patient the patient fully understand and signed the informed consent form
Exclusion
- Patient has survived a suicide attempt or has acute suicidal tendencies (MADRS Item 10 \> 4).
- Comorbidity according to DSM-V, axis I except major depressive disorder.
- Failed 3 or more adequate antidepressant courses in current episode of depression.
- MADRS reduction ratio ≥25% within one week from the screening to the baseline Visit.
- Depressive episode secondary to psychiatric illness or somatic disease.
- Serious and instable body disease such as cerebrovascular disease, liver and kidney disease, disease of internal secretion (abnormal thyroid function), blood disease; any history of seizures or other organic brain diseases.
- History of alcohol or drug abuse over the last 6 months
- Allergic history to bear bile pills, 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 \>1.5X 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 MECT or rTMS in nearly three months.
- Treatment with a systematic psychological treatment in nearly three months.
Key Trial Info
Start Date :
October 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04509882
Start Date
October 30 2020
End Date
March 31 2022
Last Update
August 12 2020
Active Locations (1)
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1
Jing jing Huang
Shanghai, China