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

May 11, 2020 updated by: Shanghai Mental Health Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

266

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Sixth Hospital
        • Contact:
      • Beijing, Beijing, China, 100088
        • Recruiting
        • Beijing Anding Hospital，Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 100096
        • Recruiting
        • Beijing HuiLongGuan Hospital
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400036
        • Recruiting
        • Chongqing Mental Health Center
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510370
        • Recruiting
        • Guangzhou Brain Hospital
        • Contact:
    • Hebei
      • Baoding, Hebei, China, 071000
        • Recruiting
        • The sixth People's Hospital of Hebei Province
        • Contact:
    • Henan
      • Xinxiang, Henan, China, 453002
        • Recruiting
        • The Second Affiliated Hospital of Xinxiang Medical University
        • Contact:
      • Zhumadian, Henan, China, 463000
        • Recruiting
        • Zhumadian mental Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
    • Jiangsu
      • Wuxi, Jiangsu, China, 214063
        • Recruiting
        • Wuxi Mental Health Center
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Recruiting
        • Jiangxi Mental Hospital
        • Contact:
    • Jilin
      • Siping, Jilin, China, 136000
        • Recruiting
        • Brain Hospital of Jilin Province
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:
    • Shanxi
      • Xi'an, Shanxi, China, 710061
        • Recruiting
        • Xi'an Mental Health Center
        • Contact:
    • Zhejiang
      • Ningbo, Zhejiang, China, 315201
        • Recruiting
        • Ningbo Kangning Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anyu Peibo
Anyu Peibo Capsule, oral, 0.8g twice per day
Drug: Anyu Peibo
Anyu Peibo Capsule, 0.8g twice per day, oral after breakfast and supper
Placebo Comparator: Placebo
Placebo,oral, twice per day
Drug: Placebo
Placebo Capsule, twice per day, oral after breakfast and supper

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of total score from baseline in Montgomery Asberg Depression Rating Scale （MADRS）
Time Frame: 8 weeks
the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Remission Rate according to total score of MADRS at the end of study
Time Frame: 8 weeks
Remission=at the end of study, total score of MADRS ≤10, the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome
8 weeks
Clinical Remission Rate according to 17-items Hamilton Depression Scale (HAMD17) total score at the end of study
Time Frame: 8 weeks
Remission=at the end of study, total score of HAMD17 ≤7, the minimum and maximum values of HAMD17 are from 0 to 52, and higher scores mean a worse outcome
8 weeks
The change of total score of MADRS by time
Time Frame: 8 weeks
the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome
8 weeks
The change of total score from baseline in HAMD17
Time Frame: 8 weeks
the minimum and maximum values of HAMD17 are from 0 to 52, and higher scores mean a worse outcome
8 weeks
The change of total score from baseline in Hamilton Anxiety Scale (HAMA)
Time Frame: 8 weeks
the minimum and maximum values of HAMA are from 0 to 56, and higher scores mean a worse outcome
8 weeks
The change of score from baseline in Clinical Global Impression-Severity of Illness (CGI-S)
Time Frame: 8 weeks
the minimum and maximum values of CGI-S are from 1 to 7, and higher scores mean a worse outcome
8 weeks
Clinical Global Impression-Severity of Illness (CGI-I) score
Time Frame: 8 weeks
the minimum and maximum values of CGI-I are from 1 to 7, and higher scores mean a worse outcome
8 weeks
The change of total score from baseline in Discriminative Scale Space Tracker (DSST)
Time Frame: 8 weeks
the minimum and maximum values of DSST are from 0 to 90, and higher scores mean a better outcome
8 weeks
The change of total score from baseline in Trail Making Test (TMT) A&B
Time Frame: 8 weeks
the minimum and maximum values of TMT are from 0 to 300, and higher scores mean a worse outcome
8 weeks
The change of total score from baseline in Sheehan Disability Scale (SDS)
Time Frame: 8 weeks
the minimum and maximum values of SDS are from 0 to 10, and higher scores mean a worse outcome
8 weeks
Proportion of subjects who withdrew from clinical trial due to poor efficacy
Time Frame: 8 weeks
Investigator will assess subject's efficacy according to his/her clinical status with rating scales, including MADRS, HAMD17, HAMA and CGI, which already listed in Outcome
8 weeks
Proportion of subjects who combined medication to treat insomnia
Time Frame: 8 weeks
8 weeks
Incidence rate of AE
Time Frame: 8 weeks
AE=Adverse Events
8 weeks
Breath Rate
Time Frame: 8 weeks
per minutes
8 weeks
Pulse Rate
Time Frame: 8 weeks
per minutes
8 weeks
Heartbeat Rate
Time Frame: 8 weeks
per minutes
8 weeks
Diastolic blood pressure
Time Frame: 8 weeks
Sitting position, mmHg
8 weeks
Systolic blood pressure
Time Frame: 8 weeks
Sitting position, mmHg
8 weeks
Electrocardiogram(ECG)
Time Frame: 8 weeks
the number of subjects with abnormal ECG report by 12-lead electrocardiogram
8 weeks
Assessment of Arizona Sexual Experience Scale (ASES)
Time Frame: 8 weeks
the minimum and maximum values of ASES are from 1 to 6, and higher scores mean a worse outcome
8 weeks
Number of Participants with AE result in early withdrawal from clinical trials
Time Frame: 8 weeks
8 weeks
Number of Participants with Serious Adverse Event (SAE) result in early withdrawal from clinical trials
Time Frame: 8 weeks
8 weeks
Number of Emerging AE during drug withdrawal period
Time Frame: 9 weeks
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Collaborators

Su Zhou YiHua Biotechnology Co. LTD

Investigators

  • Principal Investigator: Huafang LI, MD. PhD., Shanghai Mental Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

December 18, 2019

First Submitted That Met QC Criteria

December 20, 2019

First Posted (Actual)

December 26, 2019

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 11, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AYPB-MDD-Ⅲ-201901
  • 2018ZX09734-005 (Other Grant/Funding Number: China National Major Project for IND)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Depressive Disorder

Clinical Trials on Anyu Peibo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe