Comparison of Anyu Peibo With Placebo in Treatment of MDD in China
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: Anyu PeiboDrug: Placebo
- Registration Number
- NCT04210973
- Lead Sponsor
- Shanghai Mental Health Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 266
- Adult with primary diagnosis of major depressive disorder(MDD) based on the criteria of DSM-5, single episode or recurrent episode. [296.21; 296.22; 296.23; 296.31; 296.32; 296.33]
- The total score of MADRS is ≥26 in both screening visit and baseline visit.
- The first item of MADRS is ≥3 in both screening visit and baseline visit.
- CGI-S is ≥4 in both screening visit and baseline visit.
- The subject understands and consents to takes part in this clinical trials. The subjects should sign informed consent form.
- The subject has a current psychiatric diagnosis other than depression.
- The subject has a suicide attempt within recent 1 year, or has a currently significant risk of suicide, or has a score ≥3 on item 10 (suicidal ideation) of MADRS.
- The subject has a current depressive episode due to somatic general disease or a neurological disease, such as hypothyroidism.
- When the MADRS total score of baseline visit compares with the screening visit, the decreasing rate is ≥25%.
- Known hypersensitivity to Big Leaf Ju, or at least to two kinds of drugs.
- Any unstable cardiovascular, hepatic, renal, blood, endocrine, or other medical disease.
- Any neurological disease (such as Parkinson's Disease, cerebrovascular accident and epilepsy) or cerebral injury (traumatic or disease related).
- Had a history or a high risk related disease or medication of seizure disorder, except infantile febrile convulsion.
- The subject could not take medication or has a disease affecting drug absorption, distribution, metabolism and excretion.
- Clinically significant electrocardiographic(ECG) abnormalities in screening visit. Such as QTc ≥450 ms in male or ≥470 ms in female.
- Clinically significant abnormal laboratory values (eg. ALT or AST value above 2 times of clinical top-limit; Cr value above normal top-limit; thyroid gland function index (≥ 2 items in 5 items) above 1.2 times or below 0.8 times of the normal range, or investigator diagnosed with hypothyroidism or hyperthyroidism).
- The subject who used at least two different antidepressants with recommended dose and adequate duration (maximum dosage by at least 4 weeks according to label) treatment still had no respond.
- The subject uses antidepressant drug normally before 2 weeks of screening, and stops using psychotropic drug before randomization less than 5 half-life period (monoamine oxidase inhibitor: at least 2 weeks; fluoxetine: at least 1 month).
- The subject received systematic light therapy, laser therapy and acupuncture or other Traditional Chinese Medicine, or systemic biofeedback therap within 2 weeks.
- The subject received modified ECT, trans-cranial magnetic stimulation (TMS), vagus nerve stimulation (VNS) or systematic psychotherapy within 3 months.
- Women who were pregnant, breast-feeding, or serum-HCG(+) on screening; or planning to become pregnant within 3 months after kick-off of clinical trial.
- Education level below junior high school.
- The subject has participated in a drug clinical trial within 1 month before screening.
- The investigator thinks the subject is unsuitable to enroll in this clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anyu Peibo Anyu Peibo Anyu Peibo Capsule, oral, 0.8g twice per day Placebo Placebo Placebo,oral, twice per day
- Primary Outcome Measures
Name Time Method The change of total score from baseline in Montgomery Asberg Depression Rating Scale （MADRS） 8 weeks the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome
- Secondary Outcome Measures
Name Time Method The change of total score of MADRS by time 8 weeks the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome
The change of total score from baseline in HAMD17 8 weeks the minimum and maximum values of HAMD17 are from 0 to 52, and higher scores mean a worse outcome
The change of total score from baseline in Hamilton Anxiety Scale (HAMA) 8 weeks the minimum and maximum values of HAMA are from 0 to 56, and higher scores mean a worse outcome
Clinical Global Impression-Severity of Illness (CGI-I) score 8 weeks the minimum and maximum values of CGI-I are from 1 to 7, and higher scores mean a worse outcome
The change of total score from baseline in Discriminative Scale Space Tracker (DSST) 8 weeks the minimum and maximum values of DSST are from 0 to 90, and higher scores mean a better outcome
Clinical Remission Rate according to total score of MADRS at the end of study 8 weeks 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
Breath Rate 8 weeks per minutes
Clinical Remission Rate according to 17-items Hamilton Depression Scale (HAMD17) total score at the end of study 8 weeks 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
The change of score from baseline in Clinical Global Impression-Severity of Illness (CGI-S) 8 weeks the minimum and maximum values of CGI-S are from 1 to 7, and higher scores mean a worse outcome
The change of total score from baseline in Trail Making Test (TMT) A&B 8 weeks the minimum and maximum values of TMT are from 0 to 300, and higher scores mean a worse outcome
The change of total score from baseline in Sheehan Disability Scale (SDS) 8 weeks the minimum and maximum values of SDS are from 0 to 10, and higher scores mean a worse outcome
Proportion of subjects who combined medication to treat insomnia 8 weeks Heartbeat Rate 8 weeks per minutes
Electrocardiogram(ECG) 8 weeks the number of subjects with abnormal ECG report by 12-lead electrocardiogram
Systolic blood pressure 8 weeks Sitting position, mmHg
Assessment of Arizona Sexual Experience Scale (ASES) 8 weeks the minimum and maximum values of ASES are from 1 to 6, and higher scores mean a worse outcome
Proportion of subjects who withdrew from clinical trial due to poor efficacy 8 weeks 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
Pulse Rate 8 weeks per minutes
Incidence rate of AE 8 weeks AE=Adverse Events
Diastolic blood pressure 8 weeks Sitting position, mmHg
Number of Participants with AE result in early withdrawal from clinical trials 8 weeks Number of Participants with Serious Adverse Event (SAE) result in early withdrawal from clinical trials 8 weeks Number of Emerging AE during drug withdrawal period 9 weeks
Trial Locations
- Locations (15)
The Sixth People's Hospital of Hebei Province
🇨🇳Baoding, Hebei, China
Beijing Anding Hospital，Capital Medical University
🇨🇳Beijing, Beijing, China
Guangzhou Brain Hospital
🇨🇳Guangzhou, Guangdong, China
Beijing HuiLongGuan Hospital
🇨🇳Beijing, Beijing, China
Chongqing Mental Health Center
🇨🇳Chongqing, Chongqing, China
The Second Affiliated Hospital of Xinxiang Medical University
🇨🇳Xinxiang, Henan, China
Zhumadian mental Hospital
🇨🇳Zhumadian, Henan, China
Wuxi Mental Health Center
🇨🇳Wuxi, Jiangsu, China
Jiangxi Mental Hospital
🇨🇳Nanchang, Jiangxi, China
Shanghai Mental Health Center
🇨🇳Shanghai, Shanghai, China
XI'AN Mental Health Center
🇨🇳Xi'an, Shanxi, China
Ningbo Kangning Hospital
🇨🇳Ningbo, Zhejiang, China
Peking University Sixth Hospital
🇨🇳Beijing, Beijing, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Brain Hospital of Jilin Province
🇨🇳Siping, Jilin, China