Bear Bile Pill as add-on the Treatment of MDD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-30

Study Completion Date

2022-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

bear bile pill

Intervention Type DRUG

Bear bile pill (15 pills) taken orally three times a day after meals with water.

placebo

Patients randomized to the placebo arm will receive 15 pills, three times daily of placebo plus on-going antidepressant therapy (SSRI/SNRI).

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo(15 pills) taken orally three times a day after meals with water.

Interventions

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bear bile pill

Bear bile pill (15 pills) taken orally three times a day after meals with water.

Intervention Type DRUG

placebo

Placebo(15 pills) taken orally three times a day after meals with water.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes