comparison of anyu peibo with placebo in treatment of mdd in china

Conditions: Major Depressive Disorder

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.


Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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.