Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00384033
Collaborator
(none)
638
22
4
12
29
2.4
Study Details
Study Description
Brief Summary
The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
638 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Duloxetine-Referenced, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50mg, 100mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder
Study Start Date
:
Sep 1, 2006
Actual Primary Completion Date
:
Sep 1, 2007
Actual Study Completion Date
:
Sep 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Desvenlafaxine succinate sustained-release 50 mg
|
Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
50 mg tablet, once daily dosing for 8 weeks
|
| Experimental: Desvenlafaxine succinate sustained-release 100 mg
|
Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
100 mg tablet, once daily dosing for 8 weeks
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Matching placebo tablets and capsules, once daily dosing for 8 weeks
|
| Other: Duloxetine 60mg Active control to assess assay sensitivity |
Drug: Duloxetine 60 mg/day
60 mg capsule, once daily dosing for 8 weeks
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation [Baseline and Week 8 or FOT]
HAM-D17: 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
- Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation [Week 8 or FOT]
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale relative to the baseline assessment. Higher score = more affected.
- Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation [Baseline and Week 8 or FOT]
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 participants). Higher score = more affected.
- Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation [Baseline and Week 8 or FOT]
MADRS 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).
- Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation [Baseline and Week 8 or FOT]
Lassitude item of MADRS represents a difficulty in getting started or slowness in initiating and performing everyday activities. It is rated on a scale of 0-6: 0 = hardly any difficulty in getting started/no sluggishness; 2 = difficulties in starting activities; 4 = difficulties in starting simple routine activities which are carried out with effort; 6 = complete lassitude/unable to do anything without help.
- Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation [Baseline and Week 8 or FOT]
HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 (0=none and 2=severe) and all others are scored 0-4 (0=none/absent and 4=most severe).
- Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation [Baseline and Week 8 or FOT]
HAM-D energy subscale is a subset of the HAM-D17 that assesses 4 items associated with major depression. The scale uses HAM- D17 items 1, 7, 8 and 14. Item 14 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).
- Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation [Baseline and Week 8 or FOT]
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, to 5 = Very much. Worst value is 15 and best value is 3.
- Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation [Baseline and Week 8 or FOT]
VAS-PI scale assesses intensity of back pain, chest pain, arms, legs or joint pain as well as overall pain intensity where 100 mm line (VAS) is marked by participant and intensity of pain ranges from 0 millimetre (mm) = no pain to 100 mm = worst possible pain. There were separate 0 to 100 mm VAS lines for each subcomponent of VAS-PI.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
-
A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features.
-
Depressive symptoms for at least 30 days before the screening visit.
-
Outpatient men and women at least 18 years of age.
Exclusion Criteria:
-
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.
-
Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Beverly Hills | California | United States | 90210 |
| 2 | Pfizer Investigational Site | Burbank | California | United States | 91506 |
| 3 | Pfizer Investigational Site | Encino | California | United States | 91316 |
| 4 | Pfizer Investigational Site | Los Alamitos | California | United States | 90720 |
| 5 | Pfizer Investigational Site | Newport Beach | California | United States | 92660 |
| 6 | Pfizer Investigational Site | Northridge | California | United States | 91324 |
| 7 | Pfizer Investigational Site | Orange | California | United States | 92868 |
| 8 | Pfizer Investigational Site | Pasadena | California | United States | 91105 |
| 9 | Pfizer Investigational Site | Upland | California | United States | 91786 |
| 10 | Pfizer Investigational Site | South Miami | Florida | United States | 33143 |
| 11 | Pfizer Investigational Site | St. Petersburg | Florida | United States | 33702 |
| 12 | Pfizer Investigational Site | Edwardsville | Illinois | United States | 62025 |
| 13 | Pfizer Investigational Site | Farmington Hills | Michigan | United States | 48336 |
| 14 | Pfizer Investigational Site | Flint | Michigan | United States | 48507 |
| 15 | Pfizer Investigational Site | Okemos | Michigan | United States | 48864 |
| 16 | Pfizer Investigational Site | Clementon | New Jersey | United States | 08021 |
| 17 | Pfizer Investigational Site | Dayton | Ohio | United States | 45408 |
| 18 | Pfizer Investigational Site | Portland | Oregon | United States | 97210 |
| 19 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19149 |
| 20 | Pfizer Investigational Site | Salt Lake City | Utah | United States | 84107 |
| 21 | Pfizer Investigational Site | Seattle | Washington | United States | 98104 |
| 22 | Pfizer Investigational Site | Brown Deer | Wisconsin | United States | 53223 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00384033
Other Study ID Numbers:
- 3151A1-335
First Posted:
Oct 4, 2006
Last Update Posted:
Mar 15, 2012
Last Verified:
Feb 1, 2012
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Study was conducted from 27 September 2006 to 28 September 2007 in United States (US) only. |
|---|---|
| Pre-assignment Detail | A total of 925 participants were screened for this study and 638 participants were randomized. The remaining 287 participants were not randomized due to screen failures. |
| Arm/Group Title | Placebo | DVS SR 50 mg | DVS SR 100 mg | Duloxetine 60 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week). |
| Period Title: Overall Study | ||||
| STARTED | 164 | 155 | 160 | 159 |
| Treated | 161 | 148 | 150 | 157 |
| COMPLETED | 123 | 120 | 117 | 119 |
| NOT COMPLETED | 41 | 35 | 43 | 40 |
Baseline Characteristics
| Arm/Group Title | Placebo | DVS SR 50 mg | DVS SR 100 mg | Duloxetine 60 mg | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week). | Total of all reporting groups |
| Overall Participants | 161 | 148 | 150 | 157 | 616 |
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
39.24
(12.74)
|
40.67
(13.20)
|
38.77
(12.07)
|
38.94
(12.01)
|
39.39
(12.50)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
94
58.4%
|
102
68.9%
|
99
66%
|
104
66.2%
|
399
64.8%
|
| Male |
67
41.6%
|
46
31.1%
|
51
34%
|
53
33.8%
|
217
35.2%
|
| Hamilton psychiatric scale for depression-17 item (HAM-D17) total score (Units on a Scale) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Units on a Scale] |
23.86
(2.68)
|
23.49
(2.52)
|
23.49
(2.55)
|
22.99
(2.45)
|
23.46
(2.57)
|
| Clinical global impressions scale-severity (CGI-S) score (Units on a Scale) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Units on a Scale] |
4.39
(0.54)
|
4.29
(0.48)
|
4.31
(0.49)
|
4.28
(0.46)
|
4.32
(0.50)
|
Outcome Measures
| Title | Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation |
|---|---|
| Description | HAM-D17: 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 | Baseline and Week 8 or FOT |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication. |
| Arm/Group Title | Placebo | DVS SR 50 mg | DVS SR 100 mg | Duloxetine 60 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week). |
| Measure Participants | 160 | 148 | 150 | 157 |
| Mean (Standard Error) [Units on a Scale] |
-8.68
(0.58)
|
-9.75
(0.60)
|
-10.5
(0.60)
|
-10.3
(0.60)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 50 mg |
|---|---|---|
| Comments | For DVS SR 50 mg, HAM-D17 total score was evaluated using analysis of covariance (ANCOVA) with treatment and site as factors and baseline HAM-D17 score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.198 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.10 | |
| Confidence Interval |
(2-Sided) 95% -0.60 to 2.70 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 100 mg |
|---|---|---|
| Comments | For DVS SR 100 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.028 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.80 | |
| Confidence Interval |
(2-Sided) 95% 0.20 to 3.40 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Duloxetine 60 mg |
|---|---|---|
| Comments | For Duloxetine 60 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.047 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.70 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 3.40 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation |
|---|---|
| Description | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale relative to the baseline assessment. Higher score = more affected. |
| Time Frame | Week 8 or FOT |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication. |
| Arm/Group Title | Placebo | DVS SR 50 mg | DVS SR 100 mg | Duloxetine 60 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week). |
| Measure Participants | 160 | 148 | 150 | 157 |
| 1 = Very much improved |
31
19.3%
|
27
18.2%
|
45
30%
|
45
28.7%
|
| 2 = Much improved |
32
19.9%
|
38
25.7%
|
37
24.7%
|
35
22.3%
|
| 3 = Minimally improved |
35
21.7%
|
47
31.8%
|
28
18.7%
|
37
23.6%
|
| 4 = No change |
57
35.4%
|
34
23%
|
37
24.7%
|
37
23.6%
|
| 5 = Minimally worse |
5
3.1%
|
2
1.4%
|
2
1.3%
|
3
1.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 50 mg |
|---|---|---|
| Comments | For DVS SR 50 mg, CGI-I was evaluated using Cochran-Mantel-Haenszel (CMH) test with treatment as a factor and controlling for center. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.110 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 100 mg |
|---|---|---|
| Comments | For DVS SR 100 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Duloxetine 60 mg |
|---|---|---|
| Comments | For Duloxetine 60 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation |
|---|---|
| Description | 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 participants). Higher score = more affected. |
| Time Frame | Baseline and Week 8 or FOT |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication. |
| Arm/Group Title | Placebo | DVS SR 50 mg | DVS SR 100 mg | Duloxetine 60 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week). |
| Measure Participants | 160 | 148 | 150 | 157 |
| Mean (Standard Error) [Units on a Scale] |
-1.10
(0.09)
|
-1.25
(0.10)
|
-1.44
(0.10)
|
-1.41
(0.10)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 50 mg |
|---|---|---|
| Comments | For DVS SR 50 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.248 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.20 | |
| Confidence Interval |
(2-Sided) 95% -0.10 to 0.40 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 100 mg |
|---|---|---|
| Comments | For DVS SR 100 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.011 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.30 | |
| Confidence Interval |
(2-Sided) 95% 0.10 to 0.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Duloxetine 60 mg |
|---|---|---|
| Comments | For Duloxetine 60 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.026 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 0.30 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 0.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation |
|---|---|
| Description | MADRS 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 Week 8 or FOT |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication. |
| Arm/Group Title | Placebo | DVS SR 50 mg | DVS SR 100 mg | Duloxetine 60 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week). |
| Measure Participants | 160 | 148 | 150 | 157 |
| Baseline |
31.10
(NA)
|
30.10
(NA)
|
30.70
(NA)
|
30.80
(NA)
|
| Change at Week 8 or FOT |
-11.00
(0.82)
|
-12.70
(0.85)
|
-14.40
(0.84)
|
-14.40
(0.87)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 50 mg |
|---|---|---|
| Comments | For DVS SR 50 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.149 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.70 | |
| Confidence Interval |
(2-Sided) 95% -0.60 to 4.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 100 mg |
|---|---|---|
| Comments | For DVS SR 100 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.30 | |
| Confidence Interval |
(2-Sided) 95% 1.10 to 5.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Duloxetine 60 mg |
|---|---|---|
| Comments | For Duloxetine 60 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.40 | |
| Confidence Interval |
(2-Sided) 95% 1.10 to 5.80 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation |
|---|---|
| Description | Lassitude item of MADRS represents a difficulty in getting started or slowness in initiating and performing everyday activities. It is rated on a scale of 0-6: 0 = hardly any difficulty in getting started/no sluggishness; 2 = difficulties in starting activities; 4 = difficulties in starting simple routine activities which are carried out with effort; 6 = complete lassitude/unable to do anything without help. |
| Time Frame | Baseline and Week 8 or FOT |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication. |
| Arm/Group Title | Placebo | DVS SR 50 mg | DVS SR 100 mg | Duloxetine 60 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week). |
| Measure Participants | 160 | 148 | 150 | 157 |
| Baseline |
3.49
(NA)
|
3.53
(NA)
|
3.70
(NA)
|
3.50
(NA)
|
| Change at Week 8 or FOT |
-1.27
(0.12)
|
-1.39
(0.13)
|
-1.54
(0.13)
|
-1.26
(0.12)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 50 mg |
|---|---|---|
| Comments | For DVS SR 50 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.473 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.22 to 0.46 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 100 mg |
|---|---|---|
| Comments | For DVS SR 100 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.119 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.07 to 0.61 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Duloxetine 60 mg |
|---|---|---|
| Comments | For Duloxetine 60 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.710 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.27 to 0.40 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation |
|---|---|
| Description | HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 (0=none and 2=severe) and all others are scored 0-4 (0=none/absent and 4=most severe). |
| Time Frame | Baseline and Week 8 or FOT |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication. |
| Arm/Group Title | Placebo | DVS SR 50 mg | DVS SR 100 mg | Duloxetine 60 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week). |
| Measure Participants | 160 | 148 | 150 | 157 |
| Baseline |
13.00
(NA)
|
12.80
(NA)
|
12.90
(NA)
|
12.90
(NA)
|
| Change at Week 8 or FOT |
-4.82
(0.33)
|
-5.41
(0.35)
|
-6.15
(0.34)
|
-5.91
(0.36)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 50 mg |
|---|---|---|
| Comments | For DVS SR 50 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.215 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.60 | |
| Confidence Interval |
(2-Sided) 95% -0.30 to 1.50 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 100 mg |
|---|---|---|
| Comments | For DVS SR 100 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.30 | |
| Confidence Interval |
(2-Sided) 95% 0.40 to 2.30 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Duloxetine 60 mg |
|---|---|---|
| Comments | For Duloxetine 60 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.024 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.1 | |
| Confidence Interval |
(2-Sided) 95% 0.20 to 2.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation |
|---|---|
| Description | HAM-D energy subscale is a subset of the HAM-D17 that assesses 4 items associated with major depression. The scale uses HAM- D17 items 1, 7, 8 and 14. Item 14 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). |
| Time Frame | Baseline and Week 8 or FOT |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication. |
| Arm/Group Title | Placebo | DVS SR 50 mg | DVS SR 100 mg | Duloxetine 60 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week). |
| Measure Participants | 160 | 148 | 150 | 157 |
| Baseline |
8.38
(NA)
|
8.43
(NA)
|
8.51
(NA)
|
8.38
(NA)
|
| Change at Week 8 or FOT |
-3.13
(0.23)
|
-3.66
(0.23)
|
-3.92
(0.23)
|
-3.80
(0.24)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 50 mg |
|---|---|---|
| Comments | For DVS SR 50 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.100 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.53 | |
| Confidence Interval |
(2-Sided) 95% -0.10 to 1.17 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 100 mg |
|---|---|---|
| Comments | For DVS SR 100 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.79 | |
| Confidence Interval |
(2-Sided) 95% 0.16 to 1.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Duloxetine 60 mg |
|---|---|---|
| Comments | For Duloxetine 60 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.032 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.72 | |
| Confidence Interval |
(2-Sided) 95% 0.06 to 1.38 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation |
|---|---|
| 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, to 5 = Very much. Worst value is 15 and best value is 3. |
| Time Frame | Baseline and Week 8 or FOT |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication. |
| Arm/Group Title | Placebo | DVS SR 50 mg | DVS SR 100 mg | Duloxetine 60 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week). |
| Measure Participants | 160 | 148 | 150 | 157 |
| Baseline |
6.50
(NA)
|
6.30
(NA)
|
6.30
(NA)
|
6.30
(NA)
|
| Change at Week 8 or FOT |
-1.02
(0.12)
|
-1.15
(0.13)
|
-1.35
(0.13)
|
-1.47
(0.13)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 50 mg |
|---|---|---|
| Comments | For DVS SR 50 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.445 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.20 to 0.50 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 100 mg |
|---|---|---|
| Comments | For DVS SR 100 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.056 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.30 | |
| Confidence Interval |
(2-Sided) 95% -0.00 to 0.70 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Duloxetine 60 mg |
|---|---|---|
| Comments | For Duloxetine 60 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 0.50 | |
| Confidence Interval |
(2-Sided) 95% 0.10 to 0.90 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation |
|---|---|
| Description | VAS-PI scale assesses intensity of back pain, chest pain, arms, legs or joint pain as well as overall pain intensity where 100 mm line (VAS) is marked by participant and intensity of pain ranges from 0 millimetre (mm) = no pain to 100 mm = worst possible pain. There were separate 0 to 100 mm VAS lines for each subcomponent of VAS-PI. |
| Time Frame | Baseline and Week 8 or FOT |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication. |
| Arm/Group Title | Placebo | DVS SR 50 mg | DVS SR 100 mg | Duloxetine 60 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week). |
| Measure Participants | 160 | 148 | 150 | 157 |
| Overall pain (Baseline) |
26.30
(NA)
|
30.80
(NA)
|
25.90
(NA)
|
26.10
(NA)
|
| Stomach pain (Baseline) |
16.70
(NA)
|
19.40
(NA)
|
17.00
(NA)
|
14.00
(NA)
|
| Back pain (Baseline) |
25.90
(NA)
|
32.90
(NA)
|
28.30
(NA)
|
25.50
(NA)
|
| Chest pain (Baseline) |
9.40
(NA)
|
10.90
(NA)
|
10.40
(NA)
|
6.60
(NA)
|
| Arms, legs or joint pain (Baseline) |
25.80
(NA)
|
29.10
(NA)
|
28.70
(NA)
|
22.40
(NA)
|
| Overall pain (Change at Week 8 or FOT) |
-5.61
(1.57)
|
-9.08
(1.64)
|
-10.30
(1.63)
|
-8.84
(1.74)
|
| Stomach pain (Change at Week 8 or FOT) |
-1.86
(1.62)
|
-4.98
(1.69)
|
-6.42
(1.68)
|
-4.38
(1.58)
|
| Back pain (Change at Week 8 or FOT) |
-7.04
(1.67)
|
-10.70
(1.74)
|
-12.80
(1.73)
|
-9.33
(1.83)
|
| Chest pain (Change at Week 8 or FOT) |
-1.95
(1.12)
|
-3.34
(1.17)
|
-3.90
(1.16)
|
-1.67
(1.21)
|
| Arms, legs or joint pain (Change at Week 8 or FOT) |
-6.99
(1.70)
|
-8.98
(1.76)
|
-11.90
(1.76)
|
-8.35
(1.64)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 50 mg |
|---|---|---|
| Comments | For DVS SR 50 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.124 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.50 | |
| Confidence Interval |
(2-Sided) 95% -0.90 to 7.90 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 100 mg |
|---|---|---|
| Comments | For DVS SR 100 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.035 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.7 | |
| Confidence Interval |
(2-Sided) 95% 0.30 to 9.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Duloxetine 60 mg |
|---|---|---|
| Comments | For Duloxetine 60 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.093 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 4.10 | |
| Confidence Interval |
(2-Sided) 95% -0.70 to 8.80 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 50 mg |
|---|---|---|
| Comments | For DVS SR 50 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.177 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.10 | |
| Confidence Interval |
(2-Sided) 95% -1.40 to 7.70 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 100 mg |
|---|---|---|
| Comments | For DVS SR 100 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.048 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.60 | |
| Confidence Interval |
(2-Sided) 95% 0.10 to 9.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Duloxetine 60 mg |
|---|---|---|
| Comments | For Duloxetine 60 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.088 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.80 | |
| Confidence Interval |
(2-Sided) 95% -0.50 to 8.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 50 mg |
|---|---|---|
| Comments | For DVS SR 50 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.122 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.70 | |
| Confidence Interval |
(2-Sided) 95% -1.00 to 8.40 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 100 mg |
|---|---|---|
| Comments | For DVS SR 100 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.015 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.80 | |
| Confidence Interval |
(2-Sided) 95% 1.10 to 10.50 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Duloxetine 60 mg |
|---|---|---|
| Comments | For Duloxetine 60 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.103 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.20 | |
| Confidence Interval |
(2-Sided) 95% -0.80 to 9.20 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 50 mg |
|---|---|---|
| Comments | For DVS SR 50 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.384 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.40 | |
| Confidence Interval |
(2-Sided) 95% -1.70 to 4.50 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 100 mg |
|---|---|---|
| Comments | For DVS SR 100 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.221 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.00 | |
| Confidence Interval |
(2-Sided) 95% -1.20 to 5.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Duloxetine 60 mg |
|---|---|---|
| Comments | For Duloxetine 60 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.411 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.40 | |
| Confidence Interval |
(2-Sided) 95% -1.90 to 4.70 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 50 mg |
|---|---|---|
| Comments | For DVS SR 50 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.412 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.00 | |
| Confidence Interval |
(2-Sided) 95% -2.80 to 6.70 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Placebo, DVS SR 100 mg |
|---|---|---|
| Comments | For DVS SR 100 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.042 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.90 | |
| Confidence Interval |
(2-Sided) 95% 0.20 to 9.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Duloxetine 60 mg |
|---|---|---|
| Comments | For Duloxetine 60 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.155 |
| Comments | The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.30 | |
| Confidence Interval |
(2-Sided) 95% -1.20 to 7.80 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. | |||||||
| Arm/Group Title | Placebo | DVS SR 50 mg | DVS SR 100 mg | Duloxetine 60 mg | ||||
| Arm/Group Description | Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). | Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week). | ||||
All Cause Mortality |
||||||||
| Placebo | DVS SR 50 mg | DVS SR 100 mg | Duloxetine 60 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Placebo | DVS SR 50 mg | DVS SR 100 mg | Duloxetine 60 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/161 (1.2%) | 2/148 (1.4%) | 2/150 (1.3%) | 1/157 (0.6%) | ||||
| Gastrointestinal disorders | ||||||||
| Gastrointestinal hemorrhage | 0/161 (0%) | 0/148 (0%) | 1/150 (0.7%) | 0/157 (0%) | ||||
| General disorders | ||||||||
| Accidental injury | 1/161 (0.6%) | 1/148 (0.7%) | 0/150 (0%) | 0/157 (0%) | ||||
| Suicide attempt | 0/161 (0%) | 0/148 (0%) | 0/150 (0%) | 1/157 (0.6%) | ||||
| Nervous system disorders | ||||||||
| Suicidal ideation | 0/161 (0%) | 1/148 (0.7%) | 0/150 (0%) | 0/157 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Menorrhagia | 0/161 (0%) | 0/148 (0%) | 1/150 (0.7%) | 0/157 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma | 1/161 (0.6%) | 0/148 (0%) | 0/150 (0%) | 0/157 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Placebo | DVS SR 50 mg | DVS SR 100 mg | Duloxetine 60 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 129/161 (80.1%) | 134/148 (90.5%) | 134/150 (89.3%) | 141/157 (89.8%) | ||||
| Gastrointestinal disorders | ||||||||
| Anorexia | 7/161 (4.3%) | 14/148 (9.5%) | 14/150 (9.3%) | 29/157 (18.5%) | ||||
| Constipation | 5/161 (3.1%) | 9/148 (6.1%) | 10/150 (6.7%) | 17/157 (10.8%) | ||||
| Diarrhea | 22/161 (13.7%) | 18/148 (12.2%) | 24/150 (16%) | 26/157 (16.6%) | ||||
| Dry mouth | 25/161 (15.5%) | 26/148 (17.6%) | 31/150 (20.7%) | 33/157 (21%) | ||||
| Dyspepsia | 9/161 (5.6%) | 8/148 (5.4%) | 10/150 (6.7%) | 7/157 (4.5%) | ||||
| Nausea | 22/161 (13.7%) | 36/148 (24.3%) | 40/150 (26.7%) | 52/157 (33.1%) | ||||
| Vomitting | 4/161 (2.5%) | 3/148 (2%) | 11/150 (7.3%) | 14/157 (8.9%) | ||||
| General disorders | ||||||||
| Abdominal pain | 12/161 (7.5%) | 8/148 (5.4%) | 8/150 (5.3%) | 15/157 (9.6%) | ||||
| Asthenia | 9/161 (5.6%) | 15/148 (10.1%) | 19/150 (12.7%) | 21/157 (13.4%) | ||||
| Back pain | 10/161 (6.2%) | 3/148 (2%) | 0/150 (0%) | 5/157 (3.2%) | ||||
| Flu syndrome | 8/161 (5%) | 7/148 (4.7%) | 12/150 (8%) | 5/157 (3.2%) | ||||
| Headache | 38/161 (23.6%) | 27/148 (18.2%) | 28/150 (18.7%) | 30/157 (19.1%) | ||||
| Infection | 7/161 (4.3%) | 10/148 (6.8%) | 15/150 (10%) | 6/157 (3.8%) | ||||
| Pain | 9/161 (5.6%) | 3/148 (2%) | 4/150 (2.7%) | 4/157 (2.5%) | ||||
| Withdrawal syndrome | 24/161 (14.9%) | 42/148 (28.4%) | 42/150 (28%) | 49/157 (31.2%) | ||||
| Abnormal vision | 2/161 (1.2%) | 8/148 (5.4%) | 9/150 (6%) | 4/157 (2.5%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Myalgia | 9/161 (5.6%) | 6/148 (4.1%) | 6/150 (4%) | 5/157 (3.2%) | ||||
| Nervous system disorders | ||||||||
| Abnormal dreams | 3/161 (1.9%) | 5/148 (3.4%) | 5/150 (3.3%) | 12/157 (7.6%) | ||||
| Anxiety | 11/161 (6.8%) | 4/148 (2.7%) | 2/150 (1.3%) | 4/157 (2.5%) | ||||
| Dizziness | 15/161 (9.3%) | 15/148 (10.1%) | 26/150 (17.3%) | 27/157 (17.2%) | ||||
| Insomnia | 9/161 (5.6%) | 23/148 (15.5%) | 28/150 (18.7%) | 37/157 (23.6%) | ||||
| Somnolence | 12/161 (7.5%) | 16/148 (10.8%) | 18/150 (12%) | 33/157 (21%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Upper respiratory infection | 20/161 (12.4%) | 24/148 (16.2%) | 20/150 (13.3%) | 25/157 (15.9%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Sweating | 4/161 (2.5%) | 9/148 (6.1%) | 9/150 (6%) | 19/157 (12.1%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00384033
Other Study ID Numbers:
- 3151A1-335
First Posted:
Oct 4, 2006
Last Update Posted:
Mar 15, 2012
Last Verified:
Feb 1, 2012