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

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Hypidone Hydrochloride tablets

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Outpatient, 18-65 years old, Male or female
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)
Montgomery-Åsberg Depression Rating Scale (MADRS) total scores in both Screening and Baseline ≥ 26
The first item of MADRS in both Screening and Baseline ≥ 3
CGI-S in both Screening and Baseline ≥ 4
Able to provide written informed consent

Exclusion Criteria:

Patients accord with other mental disorders diagnosed by DSM-5
Attempts to suicide, or who presently have a high risk of suicide, or The tenth item (Suicidal ideation) of C-SSRS ≥ 3
Baseline total scores compared with the screening period, the reduction rate of MADRS ≥ 25%
Subjects with serious or uncontrolled cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, respiratory disease
Subjects with clinically significant ECG abnormal(Male QTcF ≥ 450 msec, Female QTcF ≥ 470 msec )
Treatment with a MAOI within the 2 weeks prior to the first dose of trial medication
practicing 2 different treatment methods of antidepressants as recommended dose of full course
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
Subjects with a history of true allergic response to more than 1 class of medications
Subjects who participated in a clinical trial within the last 30 days.

Sites / Locations

Shanghai mental health center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

experimental group one

experimental group two

Arm Description

10 mg of Hypidone Hydrochloride tablets

20 mg of Hypidone Hydrochloride tablets

Outcomes

Primary Outcome Measures

Change in Montgomery-Asberg Depression Rating Scale (MADRS)

Change from baseline in MADRS scores，the *total* score ranges[0,60],higher values represent a worse outcome

Secondary Outcome Measures

Change in Hamilton Depression Scale 17 items(HAMD17)

Change from baseline in HAMD17 scores,the *total* score ranges[0,50],higher values represent a worse outcome

Change in Hamilton Anxiety Rating Scale (HAM-A)

Change from baseline in HAM-A scores,the *total* score ranges[0,56],higher values represent a worse outcome

Change in Clinical Global Impression of Severity Scale(CGI-S)

Change from baseline in CGI-S scores,the *total* score ranges[0,7],higher values represent a worse outcome

Change in Clinical Global Impression of Improvement Scale(CGI-I)

the *total* score ranges[0,7],higher values represent a worse outcome

Columbia-Suicide Severity Rating Scale (C-SSRS)

Safety index，no total score

Full Information

NCT ID

NCT03404466

First Posted

January 12, 2018

Last Updated

October 27, 2020

Sponsor

Zhejiang Huahai Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03404466

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

February 24, 2018 (Actual)

Primary Completion Date

July 10, 2018 (Actual)

Study Completion Date

July 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhejiang Huahai Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

experimental group one

Arm Type

Experimental

Arm Description

10 mg of Hypidone Hydrochloride tablets

Arm Title

experimental group two

Arm Type

Experimental

Arm Description

20 mg of Hypidone Hydrochloride tablets

Intervention Type

Drug

Intervention Name(s)

Hypidone Hydrochloride tablets

Intervention Description

Hypidone Hydrochloride tablets 10 or 20mg/day Study drug is to be given orally, twice daily, for 6 weeks

Primary Outcome Measure Information:

Title

Change in Montgomery-Asberg Depression Rating Scale (MADRS)

Description

Change from baseline in MADRS scores，the *total* score ranges[0,60],higher values represent a worse outcome

Time Frame

Screening,Baseline,8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment

Secondary Outcome Measure Information:

Title

Change in Hamilton Depression Scale 17 items(HAMD17)

Description

Change from baseline in HAMD17 scores,the *total* score ranges[0,50],higher values represent a worse outcome

Time Frame

Baseline,8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment

Title

Change in Hamilton Anxiety Rating Scale (HAM-A)

Description

Change from baseline in HAM-A scores,the *total* score ranges[0,56],higher values represent a worse outcome

Time Frame

Baseline, 8 day after treatment,15 day after treatment,29 day after treatment ,43 day after treatment

Title

Change in Clinical Global Impression of Severity Scale(CGI-S)

Description

Change from baseline in CGI-S scores,the *total* score ranges[0,7],higher values represent a worse outcome

Time Frame

Screening,Baseline, 8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment

Title

Change in Clinical Global Impression of Improvement Scale(CGI-I)

Description

the *total* score ranges[0,7],higher values represent a worse outcome

Time Frame

8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment

Title

Columbia-Suicide Severity Rating Scale (C-SSRS)

Description

Safety index，no total score

Time Frame

Baseline,15 day after treatment,43 day after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Outpatient, 18-65 years old, Male or female 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) Montgomery-Åsberg Depression Rating Scale (MADRS) total scores in both Screening and Baseline ≥ 26 The first item of MADRS in both Screening and Baseline ≥ 3 CGI-S in both Screening and Baseline ≥ 4 Able to provide written informed consent Exclusion Criteria: Patients accord with other mental disorders diagnosed by DSM-5 Attempts to suicide, or who presently have a high risk of suicide, or The tenth item (Suicidal ideation) of C-SSRS ≥ 3 Baseline total scores compared with the screening period, the reduction rate of MADRS ≥ 25% Subjects with serious or uncontrolled cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, respiratory disease Subjects with clinically significant ECG abnormal(Male QTcF ≥ 450 msec, Female QTcF ≥ 470 msec ) Treatment with a MAOI within the 2 weeks prior to the first dose of trial medication practicing 2 different treatment methods of antidepressants as recommended dose of full course 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 Subjects with a history of true allergic response to more than 1 class of medications Subjects who participated in a clinical trial within the last 30 days.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huafang Li, PhD

Organizational Affiliation

Shanghai Mental Health Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai mental health center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200030

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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