Study to Explore the Effective Doses and to Assess the Safety and Efficacy of Hypidone Hydrochloride Tablets
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
1 other identifier
interventional
240
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 major-depressive-disorder
Started Nov 2018
Shorter than P25 for phase_2 major-depressive-disorder
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2018
CompletedFirst Posted
Study publicly available on registry
November 14, 2018
CompletedStudy Start
First participant enrolled
November 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2019
CompletedOctober 30, 2020
October 1, 2020
1 year
November 9, 2018
October 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Hamilton Depression Scale 17 items(HAMD17)
Baseline,43 days after treatment
Hamilton Anxiety Rating Scale (HAM-A)
Baseline,43 days after treatment
Clinical Global Impression of Severity Scale(CGI-S)
Screening,Baseline, 8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
Clinical Global Impression of Improvement Scale(CGI-I)
8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment
Change in Digit Symbol Substitution Test (DSST)
Baseline, 43 days after treatment
- +1 more secondary outcomes
Study Arms (4)
10 mg of Hypidone Hydrochloride tablets
EXPERIMENTALHypidone Hydrochloride tablets 10mg/day Study,5mg tablet is to be given orally, twice daily, for 6 weeks
20 mg of Hypidone Hydrochloride tablets
EXPERIMENTALHypidone Hydrochloride tablets 20mg/day Study,10mg tablet is to be given orally, twice daily, for 6 weeks
40 mg of Hypidone Hydrochloride tablets
EXPERIMENTALHypidone Hydrochloride tablets 40mg/day Study,20mg tablet is to be given orally, twice daily, for 6 weeks
comparator
PLACEBO COMPARATORPlacebo tablets is to be given orally, twice daily, for 6 weeks
Interventions
Hypidone Hydrochloride tablets will be given orally, twice daily, for 6 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Beijing Anding Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Huilongguan Hospital
Beijing, Beijing Municipality, China
Peking University Sixth Hospital
Beijing, Beijing Municipality, China
Guangzhou Hui'ai Hospital
Guangzhou, Guangdong, China
Hebei Mental Health Center
Baoding, Hebei, China
Henan Psychiatric Hospital
Xinxiang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Wuhan Mental Health Center
Wuhan, Hubei, China
Nanjing Brain Hospital
Nanjing, Jiangsu, China
Wuxi Mental Health Center
Wuxi, Jiangsu, China
Jiangxi Mental Hospital
Nanchang, Jiangxi, China
Jilin Neuropsychiatric Hospital
Siping, Jilin, China
Shandong Mental Health Center
Jinan, Shandong, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030, China
Xi'an Mental Health Center
Xi’an, Shanxi, 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
Ningbo Kangning Hospital
Ningbo, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huafang Li, PhD
Shanghai Mental Health Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2018
First Posted
November 14, 2018
Study Start
November 30, 2018
Primary Completion
December 18, 2019
Study Completion
December 23, 2019
Last Updated
October 30, 2020
Record last verified: 2020-10