Back to resultsBear Bile Pill as add-on the Treatment of MDD
Primary Purpose
Major Depressive Disorder
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
bear bile pill
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Jing jing Huang
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
bear bile pill
placebo
Arm Description
Patients randomized to the bear bile pill arm will receive treatment with 15 pills, three times daily of bear bile pill (1350mg per day) plus on-going antidepressant therapy (SSRI/SNRI).
Patients randomized to the placebo arm will receive 15 pills, three times daily of placebo plus on-going antidepressant therapy (SSRI/SNRI).
Outcomes
Primary Outcome Measures
Change in the total Montgomery-Asberg Depression Rating Scale (MADRS) score between randomization and end of study.
The main objective is to explore whether bear bile pill add on SSRI or SNRI will improve the MDD symptoms after 8 weeks of treatment, and investigators assess the scale at baseline and week 1, 2, 4, 8.
Secondary Outcome Measures
Effective treatment
effectivity：MADRS or HAMD reduction ratio ≥50% reductive ratio: [（Baseline score- Endpoint score）／Baseline score]×100%
Clinical remission rate
patients who are in remission at the end of the study will be summarized by treatment group, MADRS score ≤12 or HAMD-17≤7.
The Montgomery-Asberg Depression Rating Scale (MADRS) reduction ratio
MADRS reduction ratio were used to evaluate the effectiveness of the treatment,and investigators assess the scale at baseline and week 1, 2, 4, 8.
The Hamilton Depression Rating Scale (HAM-D17) reduction ratio
the Hamilton Depression Rating Scale reduction ratio were used to evaluate the effectiveness of the treatment,and investigators assess the scale at baseline and week 1, 2, 4, 8.
change in the total score of the Hamilton Anxiety Scale(HAMA)
change in total score of the Clinical Global Impression-Severity (CGI-S) scale.
change in total score of the Clinical Global Impression-Improvement (CGI-I) scale.
Full Information
NCT ID
NCT04509882
First Posted
August 10, 2020
Last Updated
August 11, 2020
Sponsor
Shanghai Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT04509882
Brief Title
Bear Bile Pill as add-on the Treatment of MDD
Official Title
Add-on Study of Bear Bile Pill for Patients With Major Depressive Disorder (MDD)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2020 (Anticipated)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 purpose of this study is to determine the efficacy and safety of bear bile pill in reducing symptoms of depression in Major Depressive Disorder (MDD)patients with inadequate response to current antidepressant therapy. Following a screening period, subjects who meet the entry criteria will be randomized to treated with either placebo or 450mg bear bile pill three times daily for 8 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bear bile pill
Arm Type
Experimental
Arm Description
Patients randomized to the bear bile pill arm will receive treatment with 15 pills, three times daily of bear bile pill (1350mg per day) plus on-going antidepressant therapy (SSRI/SNRI).
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Patients randomized to the placebo arm will receive 15 pills, three times daily of placebo plus on-going antidepressant therapy (SSRI/SNRI).
Intervention Type
Drug
Intervention Name(s)
bear bile pill
Intervention Description
Bear bile pill (15 pills) taken orally three times a day after meals with water.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo(15 pills) taken orally three times a day after meals with water.
Primary Outcome Measure Information:
Title
Change in the total Montgomery-Asberg Depression Rating Scale (MADRS) score between randomization and end of study.
Description
The main objective is to explore whether bear bile pill add on SSRI or SNRI will improve the MDD symptoms after 8 weeks of treatment, and investigators assess the scale at baseline and week 1, 2, 4, 8.
Time Frame
assessed from baseline to week 8(end of study)
Secondary Outcome Measure Information:
Title
Effective treatment
Description
effectivity：MADRS or HAMD reduction ratio ≥50% reductive ratio: [（Baseline score- Endpoint score）／Baseline score]×100%
Time Frame
assessed from baseline to week 8 (end of study)
Title
Clinical remission rate
Description
patients who are in remission at the end of the study will be summarized by treatment group, MADRS score ≤12 or HAMD-17≤7.
Time Frame
assessed from baseline to week 8 (end of study)
Title
The Montgomery-Asberg Depression Rating Scale (MADRS) reduction ratio
Description
MADRS reduction ratio were used to evaluate the effectiveness of the treatment,and investigators assess the scale at baseline and week 1, 2, 4, 8.
Time Frame
assessed from baseline to week 8 (end of study)
Title
The Hamilton Depression Rating Scale (HAM-D17) reduction ratio
Description
the Hamilton Depression Rating Scale reduction ratio were used to evaluate the effectiveness of the treatment,and investigators assess the scale at baseline and week 1, 2, 4, 8.
Time Frame
assessed from baseline to week 8 (end of study)
Title
change in the total score of the Hamilton Anxiety Scale(HAMA)
Time Frame
assessed from baseline to week 8 (end of study)
Title
change in total score of the Clinical Global Impression-Severity (CGI-S) scale.
Time Frame
assessed from baseline to week 8 (end of study)
Title
change in total score of the Clinical Global Impression-Improvement (CGI-I) scale.
Time Frame
assessed from baseline to week 8 (end of study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing jing Huang
Phone
+86 021 34773308
Email
jjhuang_att@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingjing huang
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jing jing Huang
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing jing Huang, Doctor
Phone
+86 021 34773308
Email
jjhuang_att@163.com
12. IPD Sharing Statement
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Bear Bile Pill as add-on the Treatment of MDD
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