Clinical trial NCT03183505: Comparison of Anyu Peibo With Placebo in Treatment of MDD，Ⅱb
Official title: Safety and Efficacy Study of Anyu Peibo in the Treatment of Major Depressive Disorder(MDD): a Ⅱb Stratified Randomized, Double-Blind, Placebo-Paralleled, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Su Zhou YiHua Biotechnology Co. LTD
First posted: 2017-06-12
Enrollment: 172
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 safety and efficacy of Anyu Peibo Capsule comparing with placebo in the treatment of Chinese Patients with Depression. And to provide some scientific evidence for protocol designing in following phase Ⅲ clinical trial.


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.
* The total score of MADRS is ≥24 in both screening visit and baseline visit.
* The total score of HAMD-17 is ≥18 and the first item (depressed mood) is ≥2 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 3(suicide assessment) of the HAMD.
* The subject has a current psychiatric diagnosis other than depression.
* When the HAMD-17 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.
* Had a history of hyperthyroidism or hypothyroidism within recent 1 year and still taking medication.
* With psychotic symptoms.
* The subject has a history of mania episode, including manic, mixed, bipolar depression or rapid cycle attack.
* The subject has a current diagnosis of depression due to a somatic disease.
* The subject could not take medication or has a disease affecting drug absorption, such as active bowel disease, partial or total intestinal obstruction, or chronic diarrhea.
* Clinically significant electrocardiographic(ECG) abnormalities in screening visit. Such as QTc ≥450 ms in male or ≥470 ms in female; Sinus bradycardia and HR ≤ 50 bpm; Ⅲ atrioventricular block; atrial fibrillation, etc.
* Clinically significant abnormal laboratory values(eg. Routine blood value above or below 1.2 times of the normal range; urine WBC, RBC or protein ≥++; ALT or AST value above 1.5 times of clinical top-limit; BUN value above 1.2 times of top-limit; Cr value above normal top-limit; thyroid gland function index above or below 1.2 times of the normal range, Fasting plasma glucose value above 1.2 times of normal top-limit; blood fat value above 1.5 times of normal top-limit).
* 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 7 half-life period (monoamine oxidase inhibitor: at least 2 weeks; fluoxetine: at least 1 month)
* The subject received light therapy within 2 weeks.
* The subject received ECT, trans-cranial magnetic stimulation, or other physics therapy within 3 months.
* The subject received systematic psychotherapy (interpersonal relationship, psychoanalytic therapy, or cognitive behavioral therapy) within 3 months or plan to use systematic psychotherapy during the study period.
* The subject has a history of substance abuse (including alcohol, drug or other psychoactive substance) within 1 year before screening.
* 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.
* 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 MADRS scale
timeFrame: 6 weeks
Secondary outcomes:
measure: Clinical Response Rate according to MADRS
timeFrame: 6 weeks
measure: Clinical Remission Rate according to MADRS
timeFrame: 6 weeks
measure: Clinical Response Rate according to HAMD-17
timeFrame: 6 weeks
measure: Clinical Remission Rate according to HAMD-17
timeFrame: 6 weeks
measure: the Change of CGI (CGI-S, CGI-I) from baseline
timeFrame: 6 weeks
measure: the Change of total score from baseline in HAMA
timeFrame: 6 weeks
Other outcomes:
measure: Physical Examination
timeFrame: 6 weeks
measure: AE
timeFrame: 6 weeks
measure: Laboratory Examination
timeFrame: 6 weeks
measure: the Change of ECG from baseline
timeFrame: 6 weeks
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: Wuhan
country: China
facility: Wuhan Mental Health Center
state: Hubei
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: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: Shanghai Mental Health Center
name: Huafang LI, Doctor
role: PRINCIPAL_INVESTIGATOR
References: