- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04509882
Bear Bile Pill as add-on the Treatment of MDD
August 11, 2020 updated by: Jingjing HUANG, Shanghai Mental Health Center
Add-on Study of Bear Bile Pill for Patients With Major Depressive Disorder (MDD)
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jing jing Huang
- Phone Number: +86 021 34773308
- Email: jjhuang_att@163.com
Study Locations
-
-
-
Shanghai, China
- Jing jing Huang
-
Contact:
- Jing jing Huang, Doctor
- Phone Number: +86 021 34773308
- Email: jjhuang_att@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: bear bile pill
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).
|
Bear bile pill (15 pills) taken orally three times a day after meals with water.
|
Placebo Comparator: placebo
Patients randomized to the placebo arm will receive 15 pills, three times daily of placebo plus on-going antidepressant therapy (SSRI/SNRI).
|
Placebo(15 pills) taken orally three times a day after meals with water.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the total Montgomery-Asberg Depression Rating Scale (MADRS) score between randomization and end of study.
Time Frame: assessed from baseline to week 8(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.
|
assessed from baseline to week 8(end of study)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effective treatment
Time Frame: assessed from baseline to week 8 (end of study)
|
effectivity:MADRS or HAMD reduction ratio ≥50% reductive ratio: [(Baseline score- Endpoint score)/Baseline score]×100%
|
assessed from baseline to week 8 (end of study)
|
Clinical remission rate
Time Frame: assessed from baseline to week 8 (end of study)
|
patients who are in remission at the end of the study will be summarized by treatment group, MADRS score ≤12 or HAMD-17≤7.
|
assessed from baseline to week 8 (end of study)
|
The Montgomery-Asberg Depression Rating Scale (MADRS) reduction ratio
Time Frame: assessed from baseline to week 8 (end of study)
|
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.
|
assessed from baseline to week 8 (end of study)
|
The Hamilton Depression Rating Scale (HAM-D17) reduction ratio
Time Frame: assessed from baseline to week 8 (end of study)
|
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.
|
assessed from baseline to week 8 (end of study)
|
change in the total score of the Hamilton Anxiety Scale(HAMA)
Time Frame: assessed from baseline to week 8 (end of study)
|
assessed from baseline to week 8 (end of study)
|
|
change in total score of the Clinical Global Impression-Severity (CGI-S) scale.
Time Frame: assessed from baseline to week 8 (end of study)
|
assessed from baseline to week 8 (end of study)
|
|
change in total score of the Clinical Global Impression-Improvement (CGI-I) scale.
Time Frame: assessed from baseline to week 8 (end of study)
|
assessed from baseline to week 8 (end of study)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jingjing huang, Shanghai Mental Health Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 30, 2020
Primary Completion (Anticipated)
March 31, 2022
Study Completion (Anticipated)
March 31, 2022
Study Registration Dates
First Submitted
August 10, 2020
First Submitted That Met QC Criteria
August 11, 2020
First Posted (Actual)
August 12, 2020
Study Record Updates
Last Update Posted (Actual)
August 12, 2020
Last Update Submitted That Met QC Criteria
August 11, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCTNCT04002259
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depressive Disorder
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on bear bile pill
-
Stanford UniversityRecruitingPTSD | Depression, Anxiety | Trauma, PsychologicalUnited States
-
Miach OrthopaedicsRecruitingAnterior Cruciate Ligament InjuriesUnited States
-
Miach OrthopaedicsActive, not recruiting
-
NYU Langone HealthNot yet recruiting
-
Miach OrthopaedicsActive, not recruitingAnterior Cruciate Ligament Rupture | Anterior Cruciate Ligament InjuryUnited States
-
Boston University Charles River CampusWithdrawnEating DisordersUnited States
-
Hvidovre University HospitalWithdrawn
-
Karolinska InstitutetKarolinska University Hospital; University Hospital, Linkoeping; Danderyd Hospital and other collaboratorsTerminated
-
CHU de ReimsCompletedCholangiocarcinoma, Cancer of the Head of the PancreasFrance
-
University of Southern CaliforniaCompletedCholestasis, ExtrahepaticUnited States