The purpose of this study is to evaluate the efficacy and safety of Anyu Peibo Capsule comparing with placebo in the treatment of Chinese Patients with Depression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
266
Anyu Peibo Capsule, 0.8g twice per day, oral after breakfast and supper
Placebo Capsule, twice per day, oral after breakfast and supper
Beijing Anding Hospital,Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGBeijing HuiLongGuan Hospital
Beijing, Beijing Municipality, China
The change of total score from baseline in Montgomery Asberg Depression Rating Scale (MADRS)
the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome
Time frame: 8 weeks
Clinical Remission Rate according to total score of MADRS at the end of study
Remission=at the end of study, total score of MADRS ≤10, the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome
Time frame: 8 weeks
Clinical Remission Rate according to 17-items Hamilton Depression Scale (HAMD17) total score at the end of study
Remission=at the end of study, total score of HAMD17 ≤7, the minimum and maximum values of HAMD17 are from 0 to 52, and higher scores mean a worse outcome
Time frame: 8 weeks
The change of total score of MADRS by time
the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome
Time frame: 8 weeks
The change of total score from baseline in HAMD17
the minimum and maximum values of HAMD17 are from 0 to 52, and higher scores mean a worse outcome
Time frame: 8 weeks
The change of total score from baseline in Hamilton Anxiety Scale (HAMA)
the minimum and maximum values of HAMA are from 0 to 56, and higher scores mean a worse outcome
Time frame: 8 weeks
The change of score from baseline in Clinical Global Impression-Severity of Illness (CGI-S)
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Peking University Sixth Hospital
Beijing, Beijing Municipality, China
RECRUITINGChongqing Mental Health Center
Chongqing, Chongqing Municipality, China
RECRUITINGGuangzhou Brain Hospital
Guangzhou, Guangdong, China
RECRUITINGThe Sixth People's Hospital of Hebei Province
Baoding, Hebei, China
RECRUITINGThe Second Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
RECRUITINGZhumadian mental Hospital
Zhumadian, Henan, China
RECRUITINGRenmin Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGWuxi Mental Health Center
Wuxi, Jiangsu, China
RECRUITING...and 5 more locations
the minimum and maximum values of CGI-S are from 1 to 7, and higher scores mean a worse outcome
Time frame: 8 weeks
Clinical Global Impression-Severity of Illness (CGI-I) score
the minimum and maximum values of CGI-I are from 1 to 7, and higher scores mean a worse outcome
Time frame: 8 weeks
The change of total score from baseline in Discriminative Scale Space Tracker (DSST)
the minimum and maximum values of DSST are from 0 to 90, and higher scores mean a better outcome
Time frame: 8 weeks
The change of total score from baseline in Trail Making Test (TMT) A&B
the minimum and maximum values of TMT are from 0 to 300, and higher scores mean a worse outcome
Time frame: 8 weeks
The change of total score from baseline in Sheehan Disability Scale (SDS)
the minimum and maximum values of SDS are from 0 to 10, and higher scores mean a worse outcome
Time frame: 8 weeks
Proportion of subjects who withdrew from clinical trial due to poor efficacy
Investigator will assess subject's efficacy according to his/her clinical status with rating scales, including MADRS, HAMD17, HAMA and CGI, which already listed in Outcome
Time frame: 8 weeks
Proportion of subjects who combined medication to treat insomnia
Time frame: 8 weeks
Incidence rate of AE
AE=Adverse Events
Time frame: 8 weeks
Breath Rate
per minutes
Time frame: 8 weeks
Pulse Rate
per minutes
Time frame: 8 weeks
Heartbeat Rate
per minutes
Time frame: 8 weeks
Diastolic blood pressure
Sitting position, mmHg
Time frame: 8 weeks
Systolic blood pressure
Sitting position, mmHg
Time frame: 8 weeks
Electrocardiogram(ECG)
the number of subjects with abnormal ECG report by 12-lead electrocardiogram
Time frame: 8 weeks
Assessment of Arizona Sexual Experience Scale (ASES)
the minimum and maximum values of ASES are from 1 to 6, and higher scores mean a worse outcome
Time frame: 8 weeks
Number of Participants with AE result in early withdrawal from clinical trials
Time frame: 8 weeks
Number of Participants with Serious Adverse Event (SAE) result in early withdrawal from clinical trials
Time frame: 8 weeks
Number of Emerging AE during drug withdrawal period
Time frame: 9 weeks