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.
Overview
- Phase
- Phase 3
- Intervention
- Desvenlafaxine Succinate Sustained-Release Tablet , Duloxetine Hydrochloride Enteric-coated Capsule Placebo
- Conditions
- Major Depressive Disorder
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Enrollment
- 420
- Locations
- 1
- Primary Endpoint
- Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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 \>
- •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.
Arms & Interventions
Desvenlafaxine Succinate Sustained-Release
Intervention: Desvenlafaxine Succinate Sustained-Release Tablet , Duloxetine Hydrochloride Enteric-coated Capsule Placebo
Desvenlafaxine Succinate Sustained-Release
Intervention: Duloxetine Hydrochloride Enteric-coated Capsule Placebo
Duloxetine Hydrochloride Enteric-coated
Intervention: Desvenlafaxine Succinate Sustained-Release Tablet Placebo, Duloxetine Hydrochloride Enteric-coated Capsule
Duloxetine Hydrochloride Enteric-coated
Intervention: Duloxetine Hydrochloride Enteric-coated Capsule
Outcomes
Primary Outcomes
Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
Time Frame: Baseline to Week 8
Hamilton Rating Scale for Depression, 17-item is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline.
Secondary Outcomes
- Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate(Baseline to Week 8)
- Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate(Baseline to Week 8)
- Change From Baseline on the Hamilton Rating Scale for Anxiety (HAM-A) Total Score(Baseline to Week 8)
- Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)(Baseline to Week 8)
- Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)(Baseline to Week 8)
- Change From Baseline on the Visual Analog Scale (VAS) for Pain(Baseline to Week 8)