Clinical trial NCT04364997: Study of Desvenlafaxine in Treating Major Depressive Disorder.
Official title: A Multi-center, Randomized, Double-blind, Double-simulation, Duloxetine Hydrochloride Enteric-coated Positive-control Phase III Study of Desvenlafaxine Succinate Sustained-Release in the Treatment of Major Depressive Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Desvenlafaxine
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-28
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 enteric-coated capsule (60 mg/day) in adult patients with major depressive disorder.

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-coated capsule (60 mg/day) in adult patients with major depressive disorder. A total of 400 subjects will be randomly allocated to experimental arm (desvenlafaxine succinate sustained-release tablet) and active comparator arm (duloxetine hydrochloride enteric-coated capsule) in a 1:1 ratio.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate
timeFrame: Baseline to Week 8
measure: Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate
timeFrame: Baseline to Week 8
measure: Change From Baseline on the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
timeFrame: Baseline to Week 8
measure: Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)
timeFrame: Baseline to Week 8
measure: Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)
timeFrame: Baseline to Week 8
measure: Change From Baseline on the Visual Analog Scale (VAS) for Pain
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital
Study officials:
affiliation: Department of Medicine, CSPC Clinical Development Division
name: Xuefang Xia
role: STUDY_CHAIR
References: