Status:
COMPLETED
Study of Desvenlafaxine in Treating Major Depressive Disorder.
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to evaluate if the effectiveness of desvenlafaxine succinate sustained-release tablet (50 mg/day) used for 8 weeks is not inferior to duloxetine hydrochloride ente...
Detailed Description
This is a multicenter study to evaluate if the effectiveness of desvenlafaxine succinate sustained-release tablet (50 mg/day) used for 8 weeks is not inferior to duloxetine hydrochloride enteric-coate...
Eligibility Criteria
Inclusion
- 18 ≤ age ≤ 65 years old, male or female;
- Outpatients and inpatients who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria and Neuropsychiatric Interview5.0.0 (MINI5.0.0) for a primary diagnosis of Major Depressive Disorder(MDD), single or recurrent episode and measured by the Mini-International Neuropsychiatric Interview5.0.0 (MINI5.0.0) as active stage.
- Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of \>= 18.
Exclusion
- Hamilton Rating Scale for Anxiety (HAM-A) total score of \> 14.
- Refractory depression: Ineffective after adequate treatment with two or more antidepressants.
- Current or previous diagnosis of Axis I with DSM-IV other than depression.
- Significant risk of suicide based on clinical judgment or HAM-D 17, Suicide attempt in the past 6 months.
- Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2021
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04364997
Start Date
June 18 2020
End Date
September 22 2021
Last Update
December 3 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Anding Hospital
Beijing, China