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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Bear bile pill (15 pills) taken orally three times a day after meals with water.
Placebo(15 pills) taken orally three times a day after meals with water.
Jing jing Huang
Shanghai, China
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.
Time frame: assessed from baseline to week 8(end of study)
Effective treatment
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)
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.
Time frame: assessed from baseline to week 8 (end of study)
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.
Time frame: assessed from baseline to week 8 (end of study)
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.
Time frame: 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)
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change in total score of the Clinical Global Impression-Severity (CGI-S) scale.
Time frame: 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)