Comparison of Yuxintine With Placebo in Treatment of MDD

March 20, 2015 updated by: Shanghai Mental Health Center

Proof Of Concept Study of Yuxintine in the Treatment of Major Depressive Disorder(MDD): a Randomized, Double-Blind, Placebo-Paralleled,Dose-Finding, Multicenter Clinical Trial

The purpose of this study is to determine whether Yuxintine Capsule in different doses are effective in the treatment of Depression.

And to explore the preliminary information of safety and efficacy of Yuxintine Capsule in the 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.
160

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 2

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: 86-21-34773128
  • Email: lhlh_5@163.com

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100096
        • Beijing Huilongguan Hospital
      • Beijing, Beijing, China, 100083
        • Peking University Sixth Hospital
    • Chongqing
      • Chongqing, Chongqing, China, 404000
        • The First Affiliated Hospital of Chongqing Medical University
    • Guangdong
      • Shenzhen, Guangdong, China, 518020
        • Shenzhen mental health center
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The People's Hospital of Guangxi Zhuang Autonomous Region
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • Affiliated Hospital of Guiyang Medical College
    • Hebei
      • Shijiazhuang, Hebei, China, 071000
        • Hebei Mental Health Center
    • Hunan
      • Changsha, Hunan, China, 410007
        • Hunan Brain Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Mental Health Center
    • Tianjin
      • Tianjin, Tianjin, China, 300074
        • Tianjin Anding Hospital

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-IV-TR, single episode or recurrent episode, not accompanied with psychotic symptoms. Coding of diagnosis included: 296.2 and 296.3.
  • The Subject with Heart-Spleen Deficiency based on the CTM.
  • The total score of MADRS is ≥22 in both screening visit and baseline visit.
  • The total score of HAMD-17 is ≥18 and ≤30, AND item 1 ≥2 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.

Exclusion Criteria:

  • The subject made a suicide attempt in recent 6 months or has a score ≥3 on item 3(suicide assessment) of the HAMD.
  • The subject has a current DSM-Ⅳ-TR axisⅠpsychiatric diagnosis other than depression.
  • When the MADRS score of baseline visit compares with the screening visit, the decreasing rate is ≥25%.
  • Any unstable cardiovascular, hepatic, renal, endocrine(thyroid gland dysfunction), blood(e.g. bleeding tendency),or other medical disease.
  • Had a history of seizure disorder,except infantile febrile convulsion.
  • The subject has accepted psychosurgery or electroconvulsive therapy within 3 months.
  • With psychotic symptoms.
  • The subject has a history of mania episode, including manic, mixed or rapid cycle attack.
  • The subject has a current diagnosis or history of depression due to any other psychotic disorder or a general medical condition.
  • The subject with refractory depressive disorder,i.e.the patients who used at least two different mechanisms antidepressants with adequate dosage and duration treatment still had no respond.
  • Clinically significant electrocardiographic(ECG) abnormalities or abnormal laboratory values(eg. Hepatic function above 1.5 times of clinical toplimit, renal function index above toplimit, abnormal coagulation function and clinical significance of abnormality, i.e. Prothrombin time shorten or extend more than 3 seconds or a dynamic variation or APTT prolonged more than 10 seconds,AND fibrinogen L or been progressive decline, or > 4.0 g/L).
  • The subject has a diagnosis of alcohol or other substance abuse or dependence at least 1 years prior to the baseline visit.
  • Known hypersensitivity to Ginseng, or at least to two kinds of drugs, or serious allergic physique.
  • Women who were pregnant, breast-feeding, or planning to become pregnant during study. Men who have request to fertility during study period. The subject could not take safe and effective birth control measures.
  • The subject could not take medication according to the doctor's advice.
  • The subject uses antidepressant drug normally before 2 weeks of screening, and stops using psychotropic drug less than 7 half-life period (monoamine oxidase inhibitor more than 2 weeks).
  • The subject has participated in a drug clinical trial within 3 months before screening.
  • The investigator think the subject is unsuitable to enrol 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: Yuxintine 200mg per day
Yuxintine 200mg oral, once a day, 6 weeks
Drug: Yuxintine
Experimental: Yuxintine 300mg per day
Yuxintine 300mg oral, once a day, 6 weeks
Drug: Yuxintine
Experimental: Yuxintine 400mg per day
Yuxintine 400mg oral, once a day, 6 weeks
Drug: Yuxintine
Placebo Comparator: Placebo
Placebo oral, once a day, 6 weeks
Drug: Yuxintine

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
Time Frame
The change of total score from baseline in MADRS scale
Time Frame: 6 weeks
6 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
Time Frame
clinical response rate according to MADRS
Time Frame: 6 weeks
6 weeks
clinical remission rate according to MADRS
Time Frame: 6 weeks
6 weeks
CGI(CGI-S,CGI-I)
Time Frame: 6 weeks
6 weeks
The change of total score from baseline in HAMD scale
Time Frame: 6 weeks
6 weeks
decreasing rate from baseline in HAMD scale
Time Frame: 6 weeks
6 weeks
clinical remission rate according to HAMD
Time Frame: 6 weeks
6 weeks
change from baseline in HAMA
Time Frame: 6 weeks
6 weeks
Traditional Chinese Medicine Syndrome Scale
Time Frame: 6 weeks
6 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ECG
Time Frame: 6 weeks
6 weeks
vital sign
Time Frame: 6 weeks
Blood pressure, heart rate, temperature and respiratory rate
6 weeks
The Arizona Sexual Experience Scale (ASEX)
Time Frame: 6 weeks
6 weeks
laboratory examination
Time Frame: 6 weeks
Blood RT, Urinalysis,Hepatic function,Renal function,FBG,Lipid,Thyroid Function, Blood Coagulation Test and U-HCG
6 weeks
AE(adverse events)
Time Frame: 6 weeks
6 weeks
Early Termination
Time Frame: 6 weeks
6 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.
Shanghai Innovative Research Center of Traditional Chinese Medicine

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

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.
March 1, 2015

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.
March 1, 2016

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.
April 1, 2016

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).
March 17, 2015

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.
March 17, 2015

First Posted (Estimate)

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.
March 23, 2015

Study Record Updates

Last Update Posted (Estimate)

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.
March 24, 2015

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.
March 20, 2015

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.
March 1, 2015

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.
  • Yuxintine Capsule-MDD-Ⅱb
  • 2012ZX09303-003 (Other Identifier: China National Major Project)

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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