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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03739632
• Other study ID #: HYP202-CTP
• Status: Completed
• Phase: Phase 2
• Start date: November 30, 2018
• Est. completion date: December 23, 2019

Study information

• Verified date: October 2020
• Source: Zhejiang Huahai Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 23, 2019
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Hypidone Hydrochloride tablets
Hypidone Hydrochloride tablets will be given orally, twice daily, for 6 weeks

Other:
• Placebo
Placebo tablets will be given orally, twice daily, for 6 weeks

Locations

Country	Name	City	State
China	Hebei Mental Health Center	Baoding	Hebei
China	Beijing Anding Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Huilongguan Hospital	Beijing	Beijing
China	Peking University Sixth Hospital	Beijing	Beijing
China	Guangzhou Hui'ai Hospital	Guangzhou	Guangdong
China	The 7th People's Hospital of Hangzhou	Hangzhou	Zhejiang
China	the First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	The Third People's Hospital of Huzhou	Huzhou	Zhejiang
China	Shandong Mental Health Center	Jinan	Shandong
China	Jiangxi Mental Hospital	Nanchang	Jiangxi
China	Nanjing Brain Hospital	Nanjing	Jiangsu
China	Ningbo Kangning Hospital	Ningbo	Zhejiang
China	Shanghai Mental Health Center	Shanghai	Shanghai
China	Jilin Neuropsychiatric Hospital	Siping	Jilin
China	Wuhan Mental Health Center	Wuhan	Hubei
China	Wuxi Mental Health Center	Wuxi	Jiangsu
China	Xi'an Mental Health Center	Xi'an	Shanxi
China	Henan Psychiatric Hospital	Xinxiang	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Huahai Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Asberg Depression Rating Scale (MADRS)	Change from baseline in MADRS scores,the *total* score ranges[0,60],higher values represent a worse outcome	Baseline,43 days after treatment
Secondary	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,43 days after treatment
Secondary	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,43 days after treatment
Secondary	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
Secondary	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
Secondary	Change in Digit Symbol Substitution Test (DSST)		Baseline, 43 days after treatment
Secondary	Change in Trail Making Test Parts A&B (TMT)		Baseline, 43 days after treatment