Bear Bile Pill as add-on the Treatment of MDD

Major Depressive Disorder Clinical Trial

Official title:

Add-on Study of Bear Bile Pill for Patients With Major Depressive Disorder (MDD)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04509882
• Other study ID #: NCTNCT04002259
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 30, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: August 2020
• Source: Shanghai Mental Health Center
• Contact: Jing jing Huang
• Phone: +86 021 34773308
• Email: jjhuang_att[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Outpatients or inpatients.

3. Male or female subjects aged 18-65 years.

4. Patients have got standard treatment of SSRI/SNRI monotherapy for more than 4 weeks in current episode of depression before trial entry.

5. MADRS score greater than 20.

6. Women of childbearing potential must be willing to use acceptable methods of contraception throughout the study period and the following one month.

7. The patient the patient fully understand and signed the informed consent form

Exclusion Criteria:

1. Patient has survived a suicide attempt or has acute suicidal tendencies (MADRS Item 10 > 4).

2. Comorbidity according to DSM-V, axis I except major depressive disorder.

3. Failed 3 or more adequate antidepressant courses in current episode of depression.

4. MADRS reduction ratio =25% within one week from the screening to the baseline Visit.

5. Depressive episode secondary to psychiatric illness or somatic disease.

6. 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.

7. History of alcohol or drug abuse over the last 6 months

8. Allergic history to bear bile pills, or serious drug allergic history.

9. Pregnant or lactating women and women of childbearing potential throughout the study period; men who have the desire of fertility within six months;

10. 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

11. Treatment with MECT or rTMS in nearly three months.

12. Treatment with a systematic psychological treatment in nearly three months.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• bear bile pill
Bear bile pill (15 pills) taken orally three times a day after meals with water.
• placebo
Placebo(15 pills) taken orally three times a day after meals with water.

Locations

Country	Name	City	State
China	Jing jing Huang	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	assessed from baseline to week 8(end of study)
Secondary	Effective treatment	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)
Secondary	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.	assessed from baseline to week 8 (end of study)
Secondary	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.	assessed from baseline to week 8 (end of study)
Secondary	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.	assessed from baseline to week 8 (end of study)
Secondary	change in the total score of the Hamilton Anxiety Scale(HAMA)		assessed from baseline to week 8 (end of study)
Secondary	change in total score of the Clinical Global Impression-Severity (CGI-S) scale.		assessed from baseline to week 8 (end of study)
Secondary	change in total score of the Clinical Global Impression-Improvement (CGI-I) scale.		assessed from baseline to week 8 (end of study)