Status:
COMPLETED
To Explore the Safety and Efficacy of Hypidone Hydrochloride Tablets in Treatment of Patients With MDD
Lead Sponsor:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 tot...
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2018
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03404466
Start Date
February 24 2018
End Date
July 17 2018
Last Update
October 30 2020
Active Locations (1)
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1
Shanghai mental health center
Shanghai, Shanghai Municipality, China, 200030