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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
266

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Huafang LI, MD. PhD.
  • Phone Number: 86-21-34773107
  • Email: lhlh_5@163.com

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Mental Health Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Su Zhou YiHua Biotechnology Co. LTD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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