Comparison of Anyu Peibo With Placebo in Treatment of MDD in China
NCT ID: NCT04210973
Last Updated: 2020-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
266 participants
INTERVENTIONAL
2020-01-23
2021-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Anyu Peibo
Anyu Peibo Capsule, oral, 0.8g twice per day
Anyu Peibo
Anyu Peibo Capsule, 0.8g twice per day, oral after breakfast and supper
Placebo
Placebo,oral, twice per day
Placebo
Placebo Capsule, twice per day, oral after breakfast and supper
Interventions
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Anyu Peibo
Anyu Peibo Capsule, 0.8g twice per day, oral after breakfast and supper
Placebo
Placebo Capsule, twice per day, oral after breakfast and supper
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Su Zhou YiHua Biotechnology Co. LTD
UNKNOWN
Shanghai Mental Health Center
OTHER
Responsible Party
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Principal Investigators
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Huafang LI, MD. PhD.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Mental Health Center
Locations
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Beijing Anding Hospital，Capital Medical University
Beijing, Beijing Municipality, China
Beijing HuiLongGuan Hospital
Beijing, Beijing Municipality, China
Peking University Sixth Hospital
Beijing, Beijing Municipality, China
Chongqing Mental Health Center
Chongqing, Chongqing Municipality, China
Guangzhou Brain Hospital
Guangzhou, Guangdong, China
The Sixth People's Hospital of Hebei Province
Baoding, Hebei, China
The Second Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Zhumadian mental Hospital
Zhumadian, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Wuxi Mental Health Center
Wuxi, Jiangsu, China
Jiangxi Mental Hospital
Nanchang, Jiangxi, China
Brain Hospital of Jilin Province
Siping, Jilin, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
XI'AN Mental Health Center
Xi’an, Shanxi, China
Ningbo Kangning Hospital
Ningbo, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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References
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Huang J, Yu Y, Jiang Y, Chen W, Li Y, Shen Y, Zheng Q, Li H. The efficacy and safety of Anyu Peibo Capsule in the treatment of patients with major depressive disorder in China: study protocol for a randomized placebo-controlled trial. Trials. 2021 Sep 3;22(1):585. doi: 10.1186/s13063-021-05550-9.
Related Links
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EMEA :Guideline on clinical investigation of medicinal products in the treatment of depression.
FDA.Major Depressive Disorder：Developing Drug for Treatment Guidance for Industry.
Other Identifiers
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2018ZX09734-005
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AYPB-MDD-Ⅲ-201901
Identifier Type: -
Identifier Source: org_study_id
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