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Study to Explore the Effective Doses and to Assess the Safety and Efficacy of Hypidone Hydrochloride Tablets

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Hypidone Hydrochloride tablets
Placebo
Sponsored by
Zhejiang Huahai Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  1. Outpatient or Inpatient, 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 forms

Exclusion Criteria:

  1. Subjects accord with other mental disorders diagnosed by DSM-5
  2. Subjects who attempted to suicide, or who presently have a high risk of suicide, or with 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 (≥6 weeks)
  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, or who 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

Sites / Locations

  • Beijing Anding Hospital, Capital Medical University
  • Beijing Huilongguan Hospital
  • Peking University Sixth Hospital
  • Guangzhou Hui'ai Hospital
  • Hebei Mental Health Center
  • Henan Psychiatric Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Wuhan Mental Health Center
  • Nanjing Brain Hospital
  • Wuxi Mental Health Center
  • Jiangxi Mental Hospital
  • Jilin Neuropsychiatric Hospital
  • Shandong Mental Health Center
  • Shanghai Mental Health Center
  • Xi'an Mental Health Center
  • The 7th People's Hospital of Hangzhou
  • the First Affiliated Hospital of Zhejiang University
  • The Third People's Hospital of Huzhou
  • Ningbo Kangning Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

10 mg of Hypidone Hydrochloride tablets

20 mg of Hypidone Hydrochloride tablets

40 mg of Hypidone Hydrochloride tablets

comparator

Arm Description

Hypidone Hydrochloride tablets 10mg/day Study,5mg tablet is to be given orally, twice daily, for 6 weeks

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

Hypidone Hydrochloride tablets 40mg/day Study,20mg tablet is to be given orally, twice daily, for 6 weeks

Placebo tablets is to be given orally, twice daily, for 6 weeks

Outcomes

Primary Outcome Measures

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

Hamilton Depression Scale 17 items(HAMD17)
Change from baseline in HAMD17 scores,the *total* score ranges[0,50],higher values represent a worse outcome
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
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
Clinical Global Impression of Improvement Scale(CGI-I)
the *total* score ranges[0,7],higher values represent a worse outcome
Change in Digit Symbol Substitution Test (DSST)
Change in Trail Making Test Parts A&B (TMT)

Full Information

First Posted
November 9, 2018
Last Updated
October 27, 2020
Sponsor
Zhejiang Huahai Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03739632
Brief Title
Study to Explore the Effective Doses and to Assess the Safety and Efficacy of Hypidone Hydrochloride Tablets
Official Title
A Multicenter, Randomized, Double-blind, Placebo Controlled Study to Explore the Effective Doses and to Assess the Safety and Efficacy of Hypidone Hydrochloride Tablets in Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
December 18, 2019 (Actual)
Study Completion Date
December 23, 2019 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

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 scores from baseline to week 6.
Detailed Description
A total of 240 major depressive disorder (MDD) subjects between the ages of 18-65 who have current major depressive disorder diagnosed by DSM-5 will be recruited, Eligible patients will be randomized with a 1:1:1:1 ratio into the 4 treatment arms to receive either Hypidone Hydrochloride tablets or placebo, and will be accepted into the protocol after review and providing voluntary written informed consent forms and completion of a comprehensive medical and psychiatric history, physical examination, mental status examination, and routine laboratory assessment. 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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 mg of Hypidone Hydrochloride tablets
Arm Type
Experimental
Arm Description
Hypidone Hydrochloride tablets 10mg/day Study,5mg tablet is to be given orally, twice daily, for 6 weeks
Arm Title
20 mg of Hypidone Hydrochloride tablets
Arm Type
Experimental
Arm Description
Hypidone Hydrochloride tablets 20mg/day Study,10mg tablet is to be given orally, twice daily, for 6 weeks
Arm Title
40 mg of Hypidone Hydrochloride tablets
Arm Type
Experimental
Arm Description
Hypidone Hydrochloride tablets 40mg/day Study,20mg tablet is to be given orally, twice daily, for 6 weeks
Arm Title
comparator
Arm Type
Placebo Comparator
Arm Description
Placebo tablets is to be given orally, twice daily, for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Hypidone Hydrochloride tablets
Intervention Description
Hypidone Hydrochloride tablets will be given orally, twice daily, for 6 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets will be given orally, twice daily, for 6 weeks
Primary Outcome Measure Information:
Title
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
Baseline,43 days after treatment
Secondary Outcome Measure Information:
Title
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,43 days after treatment
Title
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,43 days after treatment
Title
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
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
Change in Digit Symbol Substitution Test (DSST)
Time Frame
Baseline, 43 days after treatment
Title
Change in Trail Making Test Parts A&B (TMT)
Time Frame
Baseline, 43 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatient or Inpatient, 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 forms Exclusion Criteria: Subjects accord with other mental disorders diagnosed by DSM-5 Subjects who attempted to suicide, or who presently have a high risk of suicide, or with 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 (≥6 weeks) 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, or who 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
Beijing Anding Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Huilongguan Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University Sixth Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Guangzhou Hui'ai Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Hebei Mental Health Center
City
Baoding
State/Province
Hebei
Country
China
Facility Name
Henan Psychiatric Hospital
City
Xinxiang
State/Province
Henan
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Wuhan Mental Health Center
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Nanjing Brain Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Wuxi Mental Health Center
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
Jiangxi Mental Hospital
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
Jilin Neuropsychiatric Hospital
City
Siping
State/Province
Jilin
Country
China
Facility Name
Shandong Mental Health Center
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Xi'an Mental Health Center
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
The 7th People's Hospital of Hangzhou
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
the First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The Third People's Hospital of Huzhou
City
Huzhou
State/Province
Zhejiang
Country
China
Facility Name
Ningbo Kangning Hospital
City
Ningbo
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Learn more about this trial

Study to Explore the Effective Doses and to Assess the Safety and Efficacy of Hypidone Hydrochloride Tablets

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