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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Hypidone Hydrochloride tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group one<br>10 mg of Hypidone Hydrochloride tablets | Drug: Hypidone Hydrochloride tablets<br>* Hypidone Hydrochloride tablets 10 or 20mg/day Study drug is to be given orally, twice daily, for 6 weeks<br>|
| Experimental: experimental group two<br>20 mg of Hypidone Hydrochloride tablets | Drug: Hypidone Hydrochloride tablets<br>* Hypidone Hydrochloride tablets 10 or 20mg/day Study drug is to be given orally, twice daily, for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Screening,Baseline,8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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) | 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) | 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) | Safety index，no total score | Baseline,15 day after treatment,43 day after treatment |