Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00445679
Recruitment Status : Completed
First Posted : March 9, 2007
Results First Posted : November 4, 2013
Last Update Posted : November 4, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depressive Disorder, Major
Interventions Drug: DVS SR
Drug: Paroxetine
Enrollment 807
Recruitment Details Subjects were recruited in China, India, South Korea and Taiwan from July 2007 to December 2008.
Pre-assignment Details After a 4 to 21 day screening period, eligible subjects were treated for up to 8 weeks.
Arm/Group Title DVS SR 50 DVS SR 100 DVS SR 200 Paroxetine 20
Hide Arm/Group Description Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day Paroxetine 20 mg/day
Period Title: Overall Study
Started 203 203 205 196
Completed 155 157 139 149
Not Completed 48 46 66 47
Reason Not Completed
Adverse Event             22             12             30             19
Failed to return             1             3             2             2
Physician Decision             0             0             1             0
Lost to Follow-up             10             6             6             5
Compliance             3             2             1             2
Withdrawal of Informed Consent             0             0             1             0
Protocol Violation             2             3             3             1
Withdrawal by Subject             8             14             20             18
Lack of Efficacy             2             6             2             0
Arm/Group Title DVS SR 50 DVS SR 100 DVS SR 200 Paroxetine 20 Total
Hide Arm/Group Description Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day Paroxetine 20 mg/day Total of all reporting groups
Overall Number of Baseline Participants 203 203 205 196 807
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 203 participants 203 participants 205 participants 196 participants 807 participants
38.63  (12.96) 39.26  (13.22) 39.26  (14.69) 38.27  (13.22) 38.86  (13.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 203 participants 203 participants 205 participants 196 participants 807 participants
Female
125
  61.6%
129
  63.5%
118
  57.6%
117
  59.7%
489
  60.6%
Male
78
  38.4%
74
  36.5%
87
  42.4%
79
  40.3%
318
  39.4%
1.Primary Outcome
Title Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation.
Arm/Group Title DVS SR 50 DVS SR 100 DVS SR 200 Paroxetine 20
Hide Arm/Group Description:
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20 mg/day
Overall Number of Participants Analyzed 200 200 197 192
Measure Type: Number
Unit of Measure: percentage of responders
63 67 63 66
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS SR 50, Paroxetine 20
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.
Method of Estimation Estimation Parameter Difference
Estimated Value -3.13
Confidence Interval (2-Sided) 95%
-12.62 to 6.37
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DVS SR 100, Paroxetine 20
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
-8.50 to 10.25
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DVS SR 200, Paroxetine 20
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.
Method of Estimation Estimation Parameter Difference
Estimated Value -2.17
Confidence Interval (2-Sided) 95%
-11.68 to 7.33
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Clinical Global Impressions Scale–Improvement (CGI-I) Scores
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
Arm/Group Title DVS SR 50 DVS SR 100 DVS SR 200 Paroxetine 20
Hide Arm/Group Description:
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20 mg/day
Overall Number of Participants Analyzed 200 200 196 191
Measure Type: Number
Unit of Measure: subjects
Final - Score 1 (Very much improved) 72 78 79 72
Final - Score 2 (Much improved) 64 64 53 59
Final - Score 3 (Minimally improved) 36 34 28 37
Final - Score 4 (No change) 16 17 26 17
Final - Score 5 (Minimally worse) 8 6 10 4
Final - Score 6 (Much worse) 4 1 0 2
Final - Score 7 (Very Much worse) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS SR 50, Paroxetine 20
Comments Final on-therapy population
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.714
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DVS SR 100, Paroxetine 20
Comments Final on-therapy population
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.653
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DVS SR 200, Paroxetine 20
Comments Final on-therapy population
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.881
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Clinical Global Impressions Scale–Severity of Illness (CGI-S) Scores
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
Arm/Group Title DVS SR 50 DVS SR 100 DVS SR 200 Paroxetine 20
Hide Arm/Group Description:
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20 mg/day
Overall Number of Participants Analyzed 200 200 197 192
Measure Type: Number
Unit of Measure: subjects
Final - Score 1 (Normal, not at all ill) 40 50 53 42
Final - Score 2 (Borderline mentally ill) 49 53 47 49
Final - Score 3 (Mildly ill) 53 46 34 51
Final - Score 4 (Moderately ill) 29 30 38 27
Final - Score 5 (Markedly ill) 24 18 19 15
Final - Score 6 (Severely ill) 5 2 6 7
Final - Score 7 (Among the most extremely ill) 0 1 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS SR 50, Paroxetine 20
Comments Final on-therapy population
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.450
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DVS SR 100, Paroxetine 20
Comments Final on-therapy population
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.452
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DVS SR 200, Paroxetine 20
Comments Final on-therapy population
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.850
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
Arm/Group Title DVS SR 50 DVS SR 100 DVS SR 200 Paroxetine 20
Hide Arm/Group Description:
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20 mg/day
Overall Number of Participants Analyzed 193 193 192 185
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-16.84
(-18.37 to -15.31)
-17.84
(-19.37 to -16.31)
-16.81
(-18.43 to -15.20)
-16.54
(-18.08 to -15.00)
5.Secondary Outcome
Title Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
Arm/Group Title DVS SR 50 DVS SR 100 DVS SR 200 Paroxetine 20
Hide Arm/Group Description:
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20 mg/day
Overall Number of Participants Analyzed 192 192 191 185
Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
-11.69
(-15.10 to -8.27)
-10.00
(-13.75 to -6.26)
-9.10
(-12.75 to -5.45)
-9.52
(-12.40 to -6.63)
6.Secondary Outcome
Title Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
Arm/Group Title DVS SR 50 DVS SR 100 DVS SR 200 Paroxetine 20
Hide Arm/Group Description:
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20 mg/day
Overall Number of Participants Analyzed 200 200 197 192
Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
-6.50
(-7.08 to -5.92)
-6.51
(-7.06 to -5.95)
-6.42
(-7.03 to -5.82)
-6.58
(-7.15 to -6.01)
7.Secondary Outcome
Title Covi Anxiety Scale Score Mean Change From Baseline
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
Arm/Group Title DVS SR 50 DVS SR 100 DVS SR 200 Paroxetine 20
Hide Arm/Group Description:
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20 mg/day
Overall Number of Participants Analyzed 193 193 192 185
Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
-1.23
(-1.47 to -0.99)
-1.28
(-1.54 to -1.03)
-1.17
(-1.44 to -0.89)
-1.24
(-1.49 to -1.00)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DVS SR 50 DVS SR 100 DVS SR 200 Paroxetine 20
Hide Arm/Group Description Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day Paroxetine 20 mg/day
All-Cause Mortality
DVS SR 50 DVS SR 100 DVS SR 200 Paroxetine 20
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DVS SR 50 DVS SR 100 DVS SR 200 Paroxetine 20
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/203 (1.97%)   1/203 (0.49%)   5/205 (2.44%)   2/196 (1.02%) 
Gastrointestinal disorders         
Cholelithiasis *  0/203 (0.00%)  1/203 (0.49%)  0/205 (0.00%)  0/196 (0.00%) 
Injury, poisoning and procedural complications         
Intentional overdose *  0/203 (0.00%)  0/203 (0.00%)  1/205 (0.49%)  0/196 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Pituitary tumor benign *  1/203 (0.49%)  0/203 (0.00%)  0/205 (0.00%)  0/196 (0.00%) 
Psychiatric disorders         
Suicide attempt *  2/203 (0.99%)  0/203 (0.00%)  2/205 (0.98%)  1/196 (0.51%) 
Mania *  1/203 (0.49%)  0/203 (0.00%)  1/205 (0.49%)  0/196 (0.00%) 
Suicidal behavior *  0/203 (0.00%)  0/203 (0.00%)  2/205 (0.98%)  0/196 (0.00%) 
Suicidal ideation *  1/203 (0.49%)  0/203 (0.00%)  0/205 (0.00%)  2/196 (1.02%) 
Drug abuse *  0/203 (0.00%)  0/203 (0.00%)  0/205 (0.00%)  1/196 (0.51%) 
Major Depressive Disorder worsening *  0/203 (0.00%)  0/203 (0.00%)  0/205 (0.00%)  1/196 (0.51%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DVS SR 50 DVS SR 100 DVS SR 200 Paroxetine 20
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   128/203 (63.05%)   128/203 (63.05%)   140/205 (68.29%)   134/196 (68.37%) 
Cardiac disorders         
Palpitations *  9/203 (4.43%)  7/203 (3.45%)  12/205 (5.85%)  10/196 (5.10%) 
Gastrointestinal disorders         
Constipation *  19/203 (9.36%)  30/203 (14.78%)  20/205 (9.76%)  23/196 (11.73%) 
Dry mouth *  17/203 (8.37%)  16/203 (7.88%)  19/205 (9.27%)  12/196 (6.12%) 
Nausea *  30/203 (14.78%)  39/203 (19.21%)  41/205 (20.00%)  34/196 (17.35%) 
Dyspepsia *  12/203 (5.91%)  8/203 (3.94%)  6/205 (2.93%)  6/196 (3.06%) 
General disorders         
Asthenia *  8/203 (3.94%)  5/203 (2.46%)  11/205 (5.37%)  6/196 (3.06%) 
Infections and infestations         
Nasopharyngitis *  5/203 (2.46%)  8/203 (3.94%)  11/205 (5.37%)  13/196 (6.63%) 
Metabolism and nutrition disorders         
Anorexia *  13/203 (6.40%)  14/203 (6.90%)  12/205 (5.85%)  14/196 (7.14%) 
Nervous system disorders         
Dizziness *  30/203 (14.78%)  35/203 (17.24%)  26/205 (12.68%)  29/196 (14.80%) 
Headache *  17/203 (8.37%)  20/203 (9.85%)  16/205 (7.80%)  14/196 (7.14%) 
Somnolence *  13/203 (6.40%)  17/203 (8.37%)  11/205 (5.37%)  20/196 (10.20%) 
Sedation *  4/203 (1.97%)  5/203 (2.46%)  9/205 (4.39%)  10/196 (5.10%) 
Psychiatric disorders         
Insomnia *  27/203 (13.30%)  14/203 (6.90%)  19/205 (9.27%)  8/196 (4.08%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Name/Title: U. S. Contact Center
Organization: Wyeth
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00445679     History of Changes
Other Study ID Numbers: 3151A1-336
First Submitted: March 6, 2007
First Posted: March 9, 2007
Results First Submitted: February 26, 2010
Results First Posted: November 4, 2013
Last Update Posted: November 4, 2013