To Explore the Safety and Efficacy of Hypidone Hydrochloride Tablets in Treatment of Patients With MDD

October 27, 2020 updated by: Zhejiang Huahai Pharmaceutical Co., Ltd.

A Multicenter,Randomized,Open-label,Parallel-group,and Adaptive Design Clinical Study to Explore the Safety and Efficacy of Hypidone Hydrochloride Tablets in Treatment of Patients With Major Depressive Disorder

The objective of this study is to evaluate the safety and efficacy of Hypidone Hydrochloride tablets in treatment of patients with major depressive disorder (MDD) by evaluating the change of MADRS total score from baseline to week 6.

Study Overview

Status

Status

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

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.

Detailed Description

A total of 40 major depressive disorder (MDD) subjects between the ages of 18-65 who have current major depressive disorder diagnosed by DSM-5 will be recruited, Subjects will be accepted into the protocol after an opportunity to review and provide voluntary written informed consent and completion of a comprehensive medical and psychiatric history, physical examination, mental status examination, and routine laboratory assessments The subjects will accept the drug treatment twice daily orally for 6 weeks, During the treatment follow up will occur at 8±1 days after treatment, 15±1 days after treatment, 29±2 days after treatment ,43±2 days after treatment to evaluate the safety and efficacy of the drug.

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 (Actual)

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.
42

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
  • Phase 1

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
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Mental Health Center

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:

  1. Outpatient, 18-65 years old, Male or female
  2. Current major depressive disorder diagnosed by DSM-5,single episode(296.21, 296.22, 296.23),or recurrent episode(296.31, 296.32, 296.33)
  3. Montgomery-Åsberg Depression Rating Scale (MADRS) total scores in both Screening and Baseline ≥ 26
  4. The first item of MADRS in both Screening and Baseline ≥ 3
  5. CGI-S in both Screening and Baseline ≥ 4
  6. Able to provide written informed consent

Exclusion Criteria:

  1. Patients accord with other mental disorders diagnosed by DSM-5
  2. Attempts to suicide, or who presently have a high risk of suicide, or The tenth item (Suicidal ideation) of C-SSRS ≥ 3
  3. Baseline total scores compared with the screening period, the reduction rate of MADRS ≥ 25%
  4. Subjects with serious or uncontrolled cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, respiratory disease
  5. Subjects with clinically significant ECG abnormal(Male QTcF ≥ 450 msec, Female QTcF ≥ 470 msec )
  6. Treatment with a MAOI within the 2 weeks prior to the first dose of trial medication
  7. practicing 2 different treatment methods of antidepressants as recommended dose of full course
  8. Subjects who have had a Vagus Nerve Stimulation(VNS) device implanted or who have received Modified Electric Convulsive Therapy(MECT) or Transcranial Magnetic Stimulation (TMS) within 3 months of Screening, received light treatment, laser treatment, acupuncture and other Chinese medicine treatment, biofeedback treatment within 2 weeks of Screening
  9. Subjects with a history of true allergic response to more than 1 class of medications
  10. Subjects who participated in a clinical trial within the last 30 days.

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
  • Masking: NONE

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: experimental group one
10 mg of Hypidone Hydrochloride tablets
Drug: Hypidone Hydrochloride tablets
Hypidone Hydrochloride tablets 10 or 20mg/day Study drug is to be given orally, twice daily, for 6 weeks
EXPERIMENTAL: experimental group two
20 mg of Hypidone Hydrochloride tablets
Drug: Hypidone Hydrochloride tablets
Hypidone Hydrochloride tablets 10 or 20mg/day Study drug is to be given orally, twice daily, for 6 weeks

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
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Screening,Baseline,8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
Change from baseline in MADRS scores，the *total* score ranges[0,60],higher values represent a worse outcome
Screening,Baseline,8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment

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
Change in Hamilton Depression Scale 17 items(HAMD17)
Time Frame: Baseline,8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
Change from baseline in HAMD17 scores,the *total* score ranges[0,50],higher values represent a worse outcome
Baseline,8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
Change in Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: Baseline, 8 day after treatment,15 day after treatment,29 day after treatment ,43 day after treatment
Change from baseline in HAM-A scores,the *total* score ranges[0,56],higher values represent a worse outcome
Baseline, 8 day after treatment,15 day after treatment,29 day after treatment ,43 day after treatment
Change in Clinical Global Impression of Severity Scale(CGI-S)
Time Frame: Screening,Baseline, 8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
Change from baseline in CGI-S scores,the *total* score ranges[0,7],higher values represent a worse outcome
Screening,Baseline, 8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
Change in Clinical Global Impression of Improvement Scale(CGI-I)
Time Frame: 8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
the *total* score ranges[0,7],higher values represent a worse outcome
8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Baseline,15 day after treatment,43 day after treatment
Safety index，no total score
Baseline,15 day after treatment,43 day after treatment

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.
Zhejiang Huahai Pharmaceutical Co., Ltd.

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.
February 24, 2018

Primary Completion (ACTUAL)

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.
July 10, 2018

Study Completion (ACTUAL)

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.
July 17, 2018

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).
January 12, 2018

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.
January 12, 2018

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.
January 19, 2018

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.
October 30, 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.
October 27, 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.
October 1, 2020

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.
  • HYP201-CTP

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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