Comparison of Anyu Peibo With Placebo in Treatment of MDD in China

• Status: Recruiting
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Mental Health Center
• Collaborator: Su Zhou YiHua Biotechnology Co. LTD

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.