This is a prospective, single-arm, open-label study to evaluate the safety and efficacy of Xiongdan Wan monotherapy in patients with Major Depressive Disorder(MDD), conducted in Shang Hai Mental Health Center. Following a screening period, subjects who meet the entry criteria will be treated with 450mg Xiongdan Wan pills three times daily for 8 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Xiongdan Wan is used as 450mg three times a day after meals with water for 8 weeks. The daily dose (e.g. 450mg/bag, 3 times/day) should be strictly controlled according to the experimental design. Patients should take medicine regularly every day under the guidance of doctors.
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score compared with baseline at the end of study.
The main objective is to explore whether Xiongdan Wan improve the MDD symptoms after 8 weeks of treatment, and investigators assess the scale at week 1, 2, 4, 8.
Time frame: 8 weeks
Effective treatment
Montgomery-Asberg Depression Rating Scale (MADRS) or Hamilton Depression Rating Scale (HAMD-17)reduction ratio ≥50% reductive ratio \[(Baseline score- Endpoint score)/Baseline score\]×100%
Time frame: 8 weeks
Clinical remission rate
Patients in remission at the end of the study will be summarized, Montgomery-Asberg Depression Rating Scale (MADRS) score ≤12 or Hamilton Depression Rating Scale (HAMD-17)≤7.
Time frame: 8 weeks
The Montgomery-Asberg Depression Rating Scale (MADRS) reduction ratio
MADRS reduction ratio is used to evaluate the effectiveness of the treatment and investigators assess the scale at week 1, 2, 4, 8.
Time frame: 8 weeks
The Hamilton Depression Rating Scale (HAMD-17) reduction ratio
HAMD-17 reduction ratio is used to evaluate the effectiveness of the treatment and investigators assess the scale at week 1, 2, 4, 8.
Time frame: 8 weeks
Change in the total score of the Hamilton Anxiety Scale(HAMA)
The change of HAMA is used to evaluate the effectiveness of the treatment and investigators assess the scale at week 1, 2, 4, 8.
Time frame: 8 weeks
Change in total score of the Clinical Global Impression scale(CGI)
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The change of CGI is used to evaluate the effectiveness of the treatment and investigators assess the scale at week 1, 2, 4, 8.
Time frame: 8 weeks