Back to resultsStudy of Desvenlafaxine in Treating Major Depressive Disorder.
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Desvenlafaxine Succinate Sustained-Release Tablet , Duloxetine Hydrochloride Enteric-coated Capsule Placebo
Desvenlafaxine Succinate Sustained-Release Tablet Placebo, Duloxetine Hydrochloride Enteric-coated Capsule
Duloxetine Hydrochloride Enteric-coated Capsule Placebo
Duloxetine Hydrochloride Enteric-coated Capsule
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Desvenlafaxine
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.
Sites / Locations
- Beijing Anding Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Desvenlafaxine Succinate Sustained-Release
Duloxetine Hydrochloride Enteric-coated
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at 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 Outcome Measures
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate
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. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score.
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate
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. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of ≤ 7.
Change From Baseline on the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)
Clinical Global Impression Scale-Improvement (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome.
Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)
Clinical Global Impression-Severity Score (CGI-S): 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.
Change From Baseline on the Visual Analog Scale (VAS) for Pain
The pain level was assessed with the Visual Analog Scale, which consists of a horizontal line of 10 cm in length. For pain level assessment, "0" defines "no pain" and "10" defines "unbearable pain''. The participants are asked to mark the intensity of their pain level.
Full Information
NCT ID
NCT04364997
First Posted
April 25, 2020
Last Updated
December 1, 2021
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04364997
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 18, 2020 (Actual)
Primary Completion Date
September 22, 2021 (Actual)
Study Completion Date
September 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, Desvenlafaxine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desvenlafaxine Succinate Sustained-Release
Arm Type
Experimental
Arm Title
Duloxetine Hydrochloride Enteric-coated
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Desvenlafaxine Succinate Sustained-Release Tablet , Duloxetine Hydrochloride Enteric-coated Capsule Placebo
Intervention Description
Desvenlafaxine Succinate Sustained-Release Tablet 50 mg+Duloxetine Hydrochloride Enteric-coated Capsule Placebo 60 mg orally once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Desvenlafaxine Succinate Sustained-Release Tablet Placebo, Duloxetine Hydrochloride Enteric-coated Capsule
Intervention Description
Desvenlafaxine Succinate Sustained-Release Tablet Placebo 50mg +Duloxetine Hydrochloride Enteric-coated Capsule 60mg orally once daily for 8 weeks,
Intervention Type
Drug
Intervention Name(s)
Duloxetine Hydrochloride Enteric-coated Capsule Placebo
Intervention Description
Duloxetine Hydrochloride Enteric-coated Capsule Placebo 30 mg orally once daily for 1 week after 8-weeks treatment.
Intervention Type
Drug
Intervention Name(s)
Duloxetine Hydrochloride Enteric-coated Capsule
Intervention Description
Duloxetine Hydrochloride Enteric-coated Capsule 30mg orally once daily for 1 week after 8-weeks treatment.
Primary Outcome Measure Information:
Title
Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
Description
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.
Time Frame
Baseline to Week 8
Secondary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate
Description
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. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score.
Time Frame
Baseline to Week 8
Title
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate
Description
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. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of ≤ 7.
Time Frame
Baseline to Week 8
Title
Change From Baseline on the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Description
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
Time Frame
Baseline to Week 8
Title
Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)
Description
Clinical Global Impression Scale-Improvement (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome.
Time Frame
Baseline to Week 8
Title
Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)
Description
Clinical Global Impression-Severity Score (CGI-S): 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.
Time Frame
Baseline to Week 8
Title
Change From Baseline on the Visual Analog Scale (VAS) for Pain
Description
The pain level was assessed with the Visual Analog Scale, which consists of a horizontal line of 10 cm in length. For pain level assessment, "0" defines "no pain" and "10" defines "unbearable pain''. The participants are asked to mark the intensity of their pain level.
Time Frame
Baseline to Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuefang Xia
Organizational Affiliation
Department of Medicine, CSPC Clinical Development Division
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Anding Hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study of Desvenlafaxine in Treating Major Depressive Disorder.
We'll reach out to this number within 24 hrs