Clinical trial NCT04210973: Comparison of Anyu Peibo With Placebo in Treatment of MDD in China
Official title: Efficacy and Safety Study of Anyu Peibo in the Treatment of Major Depressive Disorder(MDD): a Ⅲ Randomized, Double-Blind, Placebo-Paralleled, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Su Zhou YiHua Biotechnology Co. LTD
First posted: 2019-12-26
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The change of total score from baseline in Montgomery Asberg Depression Rating Scale （MADRS）
timeFrame: 8 weeks
Secondary outcomes:
measure: Clinical Remission Rate according to total score of MADRS at the end of study
timeFrame: 8 weeks
measure: Clinical Remission Rate according to 17-items Hamilton Depression Scale (HAMD17) total score at the end of study
timeFrame: 8 weeks
measure: The change of total score of MADRS by time
timeFrame: 8 weeks
measure: The change of total score from baseline in HAMD17
timeFrame: 8 weeks
measure: The change of total score from baseline in Hamilton Anxiety Scale (HAMA)
timeFrame: 8 weeks
measure: The change of score from baseline in Clinical Global Impression-Severity of Illness (CGI-S)
timeFrame: 8 weeks
measure: Clinical Global Impression-Severity of Illness (CGI-I) score
timeFrame: 8 weeks
measure: The change of total score from baseline in Discriminative Scale Space Tracker (DSST)
timeFrame: 8 weeks
measure: The change of total score from baseline in Trail Making Test (TMT) A&B
timeFrame: 8 weeks
measure: The change of total score from baseline in Sheehan Disability Scale (SDS)
timeFrame: 8 weeks
measure: Proportion of subjects who withdrew from clinical trial due to poor efficacy
timeFrame: 8 weeks
measure: Proportion of subjects who combined medication to treat insomnia
timeFrame: 8 weeks
measure: Incidence rate of AE
timeFrame: 8 weeks
measure: Breath Rate
timeFrame: 8 weeks
measure: Pulse Rate
timeFrame: 8 weeks
measure: Heartbeat Rate
timeFrame: 8 weeks
measure: Diastolic blood pressure
timeFrame: 8 weeks
measure: Systolic blood pressure
timeFrame: 8 weeks
measure: Electrocardiogram(ECG)
timeFrame: 8 weeks
measure: Assessment of Arizona Sexual Experience Scale (ASES)
timeFrame: 8 weeks
measure: Number of Participants with AE result in early withdrawal from clinical trials
timeFrame: 8 weeks
measure: Number of Participants with Serious Adverse Event (SAE) result in early withdrawal from clinical trials
timeFrame: 8 weeks
measure: Number of Emerging AE during drug withdrawal period
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital，Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing HuiLongGuan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Mental Health Center
state: Chongqing
city: Guangzhou
country: China
facility: Guangzhou Brain Hospital
state: Guangdong
city: Baoding
country: China
facility: The Sixth People's Hospital of Hebei Province
state: Hebei
city: Xinxiang
country: China
facility: The Second Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Zhumadian
country: China
facility: Zhumadian mental Hospital
state: Henan
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuxi
country: China
facility: Wuxi Mental Health Center
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Mental Hospital
state: Jiangxi
city: Siping
country: China
facility: Brain Hospital of Jilin Province
state: Jilin
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Xi'an
country: China
facility: XI'AN Mental Health Center
state: Shanxi
city: Ningbo
country: China
facility: Ningbo Kangning Hospital
state: Zhejiang
Study officials:
affiliation: Shanghai Mental Health Center
name: Huafang LI, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.