Back to resultsParoxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD
Primary Purpose
Depressive Disorder, Major
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DVS SR
Paroxetine
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring major depressive disorder, MDD, depression
Eligibility Criteria
Primary Inclusion Criteria:
- Outpatient men and women at least 18 years of age.
- Have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent episode, without psychotic features.
- Have a HAM D17 total score ≥20 at the screening and baseline (study day 1) visit.
Primary Exclusion Criteria:
- Treatment with DVS SR at any time in the past.
- Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.
- 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
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
A
B
C
D
Arm Description
DVS SR 50mg/day
DVS SR 100mg/day
DVS SR 200mg/day
Paroxetine 20mg/day
Outcomes
Primary Outcome Measures
Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.
Secondary Outcome Measures
Clinical Global Impressions Scale-Improvement (CGI-I) Scores
CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the subject's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).
Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores
CGI-S is a global rating scale that measures the severity of a subject's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with subjects who have the same diagnosis (1= normal, not at all ill; 7= among the most extremely ill).
Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline
The VAS-PI is a self-rated visual analog scale for the assessment of pain. Scores on the VAS-PI range from 0 (no pain) to 10 (worst possible pain). A decrease in VAS-PI overall scores indicates a subject's assessment of an improvement in pain.
Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline
HAM-D6: standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression.
Covi Anxiety Scale Score Mean Change From Baseline
Covi anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, 5 = Very much. Total score ranges from 3 to 15; higher score indicates more anxiety.
Full Information
NCT ID
NCT00445679
First Posted
March 6, 2007
Last Updated
October 8, 2013
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00445679
Brief Title
Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD
Official Title
A Multicenter, Randomized, Double-blind, Paroxetine-referenced, Parallel-group Study to Evaluate the Safety, Efficacy, and Tolerability of 3 Fixed Doses (50mg, 100mg, AND 200mg) of Desvenlafaxine Succinate Sustained-release Tablets in Adult Outpatients With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.
Detailed Description
The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is to obtain additional information regarding the efficacy of DVS SR in subjects with MDD receiving daily doses of 50 mg, 100 mg, or 200 mg. Additional objectives include obtaining general and functional quality of life outcome data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
major depressive disorder, MDD, depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
807 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
DVS SR 50mg/day
Arm Title
B
Arm Type
Experimental
Arm Description
DVS SR 100mg/day
Arm Title
C
Arm Type
Experimental
Arm Description
DVS SR 200mg/day
Arm Title
D
Arm Type
Active Comparator
Arm Description
Paroxetine 20mg/day
Intervention Type
Drug
Intervention Name(s)
DVS SR
Intervention Description
Arm 1: 50mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Intervention Description
20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper
Primary Outcome Measure Information:
Title
Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)
Description
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impressions Scale-Improvement (CGI-I) Scores
Description
CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the subject's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).
Time Frame
8 weeks
Title
Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores
Description
CGI-S is a global rating scale that measures the severity of a subject's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with subjects who have the same diagnosis (1= normal, not at all ill; 7= among the most extremely ill).
Time Frame
8 weeks
Title
Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline
Description
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Time Frame
Baseline and 8 weeks
Title
Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline
Description
The VAS-PI is a self-rated visual analog scale for the assessment of pain. Scores on the VAS-PI range from 0 (no pain) to 10 (worst possible pain). A decrease in VAS-PI overall scores indicates a subject's assessment of an improvement in pain.
Time Frame
8 weeks
Title
Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline
Description
HAM-D6: standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression.
Time Frame
8 weeks
Title
Covi Anxiety Scale Score Mean Change From Baseline
Description
Covi anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, 5 = Very much. Total score ranges from 3 to 15; higher score indicates more anxiety.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Primary Inclusion Criteria:
Outpatient men and women at least 18 years of age.
Have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent episode, without psychotic features.
Have a HAM D17 total score ≥20 at the screening and baseline (study day 1) visit.
Primary Exclusion Criteria:
Treatment with DVS SR at any time in the past.
Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.
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
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For China: medinfo@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Beijing
ZIP/Postal Code
100083
Country
China
City
Beijing
ZIP/Postal Code
100088
Country
China
City
Guangdong Province
ZIP/Postal Code
510370
Country
China
City
Hunan Province
ZIP/Postal Code
410011
Country
China
City
Jiangsu Province
ZIP/Postal Code
210029
Country
China
City
Shanghai
ZIP/Postal Code
200030
Country
China
City
Shanghai
ZIP/Postal Code
200065
Country
China
City
Shanxi Province
ZIP/Postal Code
710032
Country
China
City
Sichuan Province
ZIP/Postal Code
610041
Country
China
City
Yunnan Province
ZIP/Postal Code
650032
Country
China
City
Zhejiang Province
ZIP/Postal Code
310003
Country
China
City
Andhra Pradesh
ZIP/Postal Code
500 038
Country
India
City
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
City
Andhra Pradesh
ZIP/Postal Code
517 507
Country
India
City
Andhra Pradesh
ZIP/Postal Code
530 002
Country
India
City
Chandigarh
ZIP/Postal Code
160012
Country
India
City
Gujarat
ZIP/Postal Code
380006
Country
India
City
Gujarat
ZIP/Postal Code
380013
Country
India
City
Karnataka
ZIP/Postal Code
575 001
Country
India
City
Karnataka
ZIP/Postal Code
575018
Country
India
City
Maharashtra
ZIP/Postal Code
400 012
Country
India
City
Maharashtra
ZIP/Postal Code
400 026
Country
India
City
Maharashtra
ZIP/Postal Code
411001
Country
India
City
Mumbai Maharashtra
ZIP/Postal Code
H19400 022
Country
India
City
New Delhi
ZIP/Postal Code
110002
Country
India
City
Punjab
ZIP/Postal Code
141001
Country
India
City
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
140-757
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
150-719
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
City
Chang-Hua
ZIP/Postal Code
ROC 500
Country
Taiwan
City
KaoHsiung
ZIP/Postal Code
ROC 80708
Country
Taiwan
City
Taipei
ZIP/Postal Code
ROC 100
Country
Taiwan
City
Taipei
ZIP/Postal Code
ROC 111
Country
Taiwan
City
Taipei
ZIP/Postal Code
ROC 112
Country
Taiwan
City
Taipei
ZIP/Postal Code
ROC 114
Country
Taiwan
City
Taipei
ZIP/Postal Code
ROC 220
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD
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