Add-on Study of Bear Bile Pill for Patients With Major Depressive Disorder (MDD)
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in the total Montgomery-Asberg Depression Rating Scale (MADRS) score between randomization and end of study.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •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
- •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
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: bear bile pill (Drug)
placebo
Patients randomized to the placebo arm will receive 15 pills, three times daily of placebo plus on-going antidepressant therapy (SSRI/SNRI).
干预措施: placebo (Drug)
结局指标
主要结局
Change in the total Montgomery-Asberg Depression Rating Scale (MADRS) score between randomization and end of study.
时间窗: 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.
次要结局
- Clinical remission rate(assessed from baseline to week 8 (end of study))
- change in total score of the Clinical Global Impression-Severity (CGI-S) scale.(assessed from baseline to week 8 (end of study))
- Effective treatment(assessed from baseline to week 8 (end of study))
- The Montgomery-Asberg Depression Rating Scale (MADRS) reduction ratio(assessed from baseline to week 8 (end of study))
- The Hamilton Depression Rating Scale (HAM-D17) reduction ratio(assessed from baseline to week 8 (end of study))
- change in the total score of the Hamilton Anxiety Scale(HAMA)(assessed from baseline to week 8 (end of study))
- change in total score of the Clinical Global Impression-Improvement (CGI-I) scale.(assessed from baseline to week 8 (end of study))
研究者
Jingjing HUANG
Shanghai Mental Health Center
Shanghai Jiao Tong University School of Medicine