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Trial record 47 of 89 for:    DESVENLAFAXINE

Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT00406640
Recruitment Status : Completed
First Posted : December 4, 2006
Results First Posted : June 29, 2010
Last Update Posted : June 29, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Depression
Depressive Disorder
Depressive Disorder, Major
Interventions Drug: Desvenlafaxine succinate sustained-release (DVS SR)
Drug: Escitalopram
Enrollment 595
Recruitment Details Subjects were recruited in Argentina, Chile, Colombia, Mexico and the United States from December 2006 to January 2008.
Pre-assignment Details Subjects were screened up to 4 weeks.
Arm/Group Title Desvenlafaxine Succinate Sustained-release (DVS SR) Escitalopram
Hide Arm/Group Description Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days. Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
Period Title: Acute Phase
Started 296 299
Completed 245 256
Not Completed 51 43
Reason Not Completed
Adverse Event             18             13
Failed to Return             5             1
Physician Decision             0             1
Lost to Follow-up             7             4
Protocol deviation             4             10
Protocol Violation             3             2
Withdrawal by Subject             11             9
Lack of Efficacy             3             3
Period Title: DB Continuation Phase for Responders
Started 172 188
Completed 139 151
Not Completed 33 37
Reason Not Completed
Adverse Event             11             11
Death             1             0
Failed to Return             0             2
Physician Decision             2             3
Lost to Follow-up             1             7
non-compliance             7             5
Protocol Violation             2             2
Withdrawal by Subject             8             6
Lack of Efficacy             1             1
Period Title: OL Extension Phase for Non-Responders
Started 69 60
Completed 47 36
Not Completed 22 24
Reason Not Completed
Adverse Event             6             6
Failed to Return             1             0
Physician Decision             1             0
Lost to Follow-up             2             3
non-compliance             3             2
Withdrawal by Subject             3             6
Lack of Efficacy             6             7
Arm/Group Title Desvenlafaxine Succinate Sustained-release (DVS SR) Escitalopram Total
Hide Arm/Group Description Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days. Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days. Total of all reporting groups
Overall Number of Baseline Participants 296 299 595
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 296 participants 299 participants 595 participants
55.78  (6.13) 56.15  (6.25) 55.97  (6.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 296 participants 299 participants 595 participants
Female
296
 100.0%
299
 100.0%
595
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 296 participants 299 participants 595 participants
United States 211 219 430
Mexico 10 9 19
Argentina 43 42 85
Chile 11 9 20
Colombia 21 20 41
1.Primary Outcome
Title Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8
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. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17.
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.
Arm/Group Title Desvenlafaxine Succinate Sustained-release (DVS SR) Escitalopram
Hide Arm/Group Description:
Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
Overall Number of Participants Analyzed 185 203
Mean (Standard Error)
Unit of Measure: units on scale
-13.63  (0.42) -14.30  (0.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-release (DVS SR), Escitalopram
Comments DVS SR compared with ESC
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.243
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.67
Confidence Interval 95%
-0.46 to 1.81
Estimation Comments DVS SR adjusted mean change minus ESC adjusted mean change.
2.Secondary Outcome
Title Percentage of Patients Achieving Response to Treatment at Final On-therapy Evaluation (Acute Phase)
Hide Description A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (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
Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.
Arm/Group Title Desvenlafaxine Succinate Sustained-release (DVS SR) Escitalopram
Hide Arm/Group Description:
Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
Overall Number of Participants Analyzed 224 237
Measure Type: Number
Unit of Measure: percentage of patients
64.3 73.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-release (DVS SR), Escitalopram
Comments DVS SR compared with ESC.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.077
Comments [Not Specified]
Method Chi-squared
Comments Logistic regression model with treatment and site as factors and baseline score as a covariant.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.608
Confidence Interval 95%
0.40 to 0.92
Estimation Comments Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.
3.Secondary Outcome
Title Percentage of Patients Achieving Remission at Final On-therapy Evaluation (Acute Phase)
Hide Description Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (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
Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.
Arm/Group Title Desvenlafaxine Succinate Sustained-release (DVS SR) Escitalopram
Hide Arm/Group Description:
Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
Overall Number of Participants Analyzed 224 237
Measure Type: Number
Unit of Measure: Percentage of patients
37.9 48.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-release (DVS SR), Escitalopram
Comments DVS SR compared with ESC.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0054
Comments [Not Specified]
Method Chi-squared
Comments Logistic regression model with treatment and site as factors and baseline score as a covariant.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.571
Confidence Interval 95%
0.39 to 0.85
Estimation Comments Estimated odds ratio of DVS SR to ESC. Odds ratio adjusted for baseline, treatment and site.
4.Secondary Outcome
Title Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks
Hide Description CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient'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
Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, took at least1 dose of study drug and had at least1 post-baseline HAM-D17 evaluation.
Arm/Group Title Desvenlafaxine Succinate Sustained-release (DVS SR) Escitalopram
Hide Arm/Group Description:
Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
Overall Number of Participants Analyzed 185 203
Mean (Standard Error)
Unit of Measure: units on scale
1.93  (0.08) 1.81  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-release (DVS SR), Escitalopram
Comments DVS SR compared with ESC
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.260
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval 95%
-0.09 to 0.33
Estimation Comments DVS SR minus ESC adjusted mean
5.Secondary Outcome
Title Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week
Hide Description CGI-S is a global rating scale that measures the severity of a patient’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 patients who have the same diagnosis (1= normal; 7= extremely ill).
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, took at least1 dose of study drug and had at least1 post-baseline HAM-D17 evaluation.
Arm/Group Title Desvenlafaxine Succinate Sustained-release (DVS SR) Escitalopram
Hide Arm/Group Description:
Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
Overall Number of Participants Analyzed 185 203
Mean (Standard Error)
Unit of Measure: units on scale
-2.09  (0.09) -2.22  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-release (DVS SR), Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.239
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.14
Confidence Interval 95%
-0.09 to 0.37
Estimation Comments DVS SR minus ESC adjusted mean
6.Secondary Outcome
Title Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score
Hide Description The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A total score minus baseline adjusted mean total score.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.
Arm/Group Title Desvenlafaxine Succinate Sustained-release (DVS SR) Escitalopram
Hide Arm/Group Description:
Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
Overall Number of Participants Analyzed 185 203
Mean (Standard Deviation)
Unit of Measure: units on scale
-11.37  (0.42) -11.73  (0.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-release (DVS SR), Escitalopram
Comments DVS SR compared to ESC
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.516
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model Repeated Measures (MMRM) analysis adjusted mean score for baseline score, time and center.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.37
Confidence Interval 95%
-0.75 to 1.49
Estimation Comments DVS SR adjusted mean change minus ESC adjusted mean change.
7.Secondary Outcome
Title Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8
Hide Description EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.
Time Frame Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.
Arm/Group Title Desvenlafaxine Succinate Sustained-release (DVS SR) Escitalopram
Hide Arm/Group Description:
Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
Overall Number of Participants Analyzed 179 189
Mean (Standard Error)
Unit of Measure: units on scale
0.25  (0.02) 0.24  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-release (DVS SR), Escitalopram
Comments DVS SR compared to ESC
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.635
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM) with treatment, time and site as factors and baseline as covariant.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.01
Confidence Interval 95%
-0.03 to 0.06
Estimation Comments DVS SR adjusted mean change minus ESC adjusted mean change
8.Secondary Outcome
Title Percentage of Responders Maintaining Response to Treatment at Final On-therapy Evaluation (Double Blind Continuation Phase)
Hide Description Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if the response was maintained. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.
Time Frame 6 months
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Hide Analysis Population Description
All randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug, had at least 1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8) and continued treatment in the double blind continuation phase.
Arm/Group Title DVS SR Responders / DVS SR DB ESC Responders / ESC DB
Hide Arm/Group Description:
Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase.
Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase.
Overall Number of Participants Analyzed 137 160
Measure Type: Number
Unit of Measure: percentage of responders
81.8 80.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS SR Responders / DVS SR DB, ESC Responders / ESC DB
Comments DVS SR compared with ESC.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.702
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.12
Confidence Interval 95%
0.63 to 2.00
Estimation Comments Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.
9.Secondary Outcome
Title Percentage of Responders Achieving Remission at Final On-therapy Evaluation (Double Blind Continuation Phase)
Hide Description Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if remission was achieved. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug, had at least 1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8) and continued treatment in the double blind continuation phase.
Arm/Group Title DVS SR Responders / DVS SR DB ESC Responders / ESC DB
Hide Arm/Group Description:
Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase.
Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase.
Overall Number of Participants Analyzed 137 160
Measure Type: Number
Unit of Measure: percentage of responders
67.9 61.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS SR Responders / DVS SR DB, ESC Responders / ESC DB
Comments DVS SR compared with ESC.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.234
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.34
Confidence Interval 95%
0.83 to 2.16
Estimation Comments Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.
10.Secondary Outcome
Title Percentage of Responders Improving Response to Remission During 6-month Double Blind Continuation Phase
Hide Description Patients achieving a response to treatment (Responders) at the end of the 8-week acute double blind (DB) phase continued into a 6-month DB phase. Responders without remission at 8 weeks were assessed for remission status during the 6-month continuation. Remission defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale assessing 17 items characteristically associated with major depression. Individual items scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with baseline HAM-D17 score ≥18, who took ≥1 dose study drug, had ≥1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) but not remission (HAM-D17 score ≤ 7) at the end of the acute phase and continued treatment in the 6-month DB continuation phase.
Arm/Group Title DVS SR Responders / DVS SR DB ESC Responders / ESC DB
Hide Arm/Group Description:
Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase.
Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase.
Overall Number of Participants Analyzed 54 55
Measure Type: Number
Unit of Measure: percentage of responders
88.9 81.8
11.Secondary Outcome
Title Percentage of Non-Responders Achieving Response at Final Evaluation of 6-month Open-Label (OL)Extension Phase
Hide Description Patients who didn't achieve a response to treatment at the end of the 8-week acute double blind phase entered into an OL treatment phase with DVS SR for 6 months and were evaluated to see if a response was achieved. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least 1 dose of study drug, who did not achieve a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8), entered into the open label extension phase and had baseline and at least 1 post-baseline HAM-D17 evaluation in the acute and open label phase.
Arm/Group Title DVS SR Non-Responders / DVS SR OL ESC Non-Responders / DVS SR OL
Hide Arm/Group Description:
Patients who received DVS SR during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
Patients who received ESC during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
Overall Number of Participants Analyzed 185 203
Measure Type: Number
Unit of Measure: Percentage of Non-Responders
39.1 50.8
12.Secondary Outcome
Title Percentage of Non-Responders Achieving Remission at Final Evaluation of 6-month Open-Label Extension Phase
Hide Description Patients who did not achieve a response to treatment at the end of the 8-week acute double blind phase entered into an open label (OL) treatment phase with DVS SR for 6 months and were evaluated to see if remission was achieved. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least 1 dose of study drug, who did not achieve a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8), entered into the open label extension phase and had baseline and at least 1 post-baseline HAM-D17 evaluation in the acute and open label phase.
Arm/Group Title DVS SR Non-Responders / DVS SR OL ESC Non-Responders / DVS SR OL
Hide Arm/Group Description:
Patients who received DVS SR during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
Patients who received ESC during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
Overall Number of Participants Analyzed 64 59
Measure Type: Number
Unit of Measure: Percentage of Non-Responders
40.6 47.5
13.Secondary Outcome
Title Discontinuation-Emergent Signs and Symptoms (DESS) Total Score
Hide Description DESS is a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms that appeared during tapering of the test article. A higher score indicates more symptoms. The DESS score was assessed by status of taper.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: Randomized patients who took ≥1 dose study drug. Excluded patients lost to follow-up and discontinued with < 4 wks therapy. Patients analyzed varied by time (DVS SR, ESC): End of Therapy (n=264, 267); Taper week 1 (n=217, 227); Taper week 2 (n=222, 223); Post-taper (n=219, 223).
Arm/Group Title Desvenlafaxine Succinate Sustained-Release (DVS SR) Escitalopram (ESC)
Hide Arm/Group Description:
Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
Taper Phase Day 239 or at discontinuation: If patients taking escitalopram 20 mg/day, then decrease to 10 mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10 mg/day decreased to matching escitalopram placebo/day for 7 days.
Overall Number of Participants Analyzed 264 267
Mean (Standard Deviation)
Unit of Measure: units on scale
End of Therapy 1.49  (3.09) 1.52  (3.65)
Taper week 1 1.18  (2.12) 1.68  (3.28)
Taper week 2 2.29  (3.46) 3.16  (4.58)
Post-taper 1.61  (3.55) 1.48  (2.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-Release (DVS SR), Escitalopram (ESC)
Comments DVS SR vs. ESC: end of therapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.927
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-Release (DVS SR), Escitalopram (ESC)
Comments DVS SR vs. ESC: after 1 week of taper
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-Release (DVS SR), Escitalopram (ESC)
Comments DVS SR vs. ESC: after 2 weeks of taper
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-Release (DVS SR), Escitalopram (ESC)
Comments DVS SR vs. ESC: after > 2 weeks of taper
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.653
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Desvenlafaxine Succinate Sustained-release (DVS SR) Escitalopram
Hide Arm/Group Description Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days. Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
All-Cause Mortality
Desvenlafaxine Succinate Sustained-release (DVS SR) Escitalopram
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Desvenlafaxine Succinate Sustained-release (DVS SR) Escitalopram
Affected / at Risk (%) Affected / at Risk (%)
Total   5   4 
Cardiac disorders     
Postural hypotension *  1/296 (0.34%)  0/299 (0.00%) 
General disorders     
Accidental injury *  0/296 (0.00%)  1/299 (0.33%) 
Non-specific drug reaction *  1/296 (0.34%)  0/299 (0.00%) 
Overdose *  0/296 (0.00%)  1/299 (0.33%) 
Suicide attempt *  2/296 (0.68%)  0/299 (0.00%) 
Hepatobiliary disorders     
Hepatitis *  1/296 (0.34%)  0/299 (0.00%) 
Hepatomegaly *  1/296 (0.34%)  0/299 (0.00%) 
Nervous system disorders     
Anxiety *  1/296 (0.34%)  0/299 (0.00%) 
Depression *  1/296 (0.34%)  1/299 (0.33%) 
Hypesthesia *  0/296 (0.00%)  1/299 (0.33%) 
Paresis *  0/296 (0.00%)  1/299 (0.33%) 
*
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 3%
Desvenlafaxine Succinate Sustained-release (DVS SR) Escitalopram
Affected / at Risk (%) Affected / at Risk (%)
Total   267   262 
Cardiac disorders     
Hypertension *  16/296 (5.41%)  15/299 (5.02%) 
Eye disorders     
Abnormal vision *  14/296 (4.73%)  17/299 (5.69%) 
Gastrointestinal disorders     
Anorexia *  20/296 (6.76%)  15/299 (5.02%) 
Constipation *  52/296 (17.57%)  28/299 (9.36%) 
Diarrhea *  26/296 (8.78%)  49/299 (16.39%) 
Dry mouth *  83/296 (28.04%)  60/299 (20.07%) 
Dyspepsia *  21/296 (7.09%)  27/299 (9.03%) 
Nausea *  74/296 (25.00%)  61/299 (20.40%) 
General disorders     
Abdominal pain *  29/296 (9.80%)  21/299 (7.02%) 
Asthenia *  27/296 (9.12%)  23/299 (7.69%) 
Back pain *  16/296 (5.41%)  13/299 (4.35%) 
Headache *  76/296 (25.68%)  85/299 (28.43%) 
Infection *  17/296 (5.74%)  21/299 (7.02%) 
Metabolism and nutrition disorders     
Metabolic and nutritional *  20/296 (6.76%)  13/299 (4.35%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal *  26/296 (8.78%)  32/299 (10.70%) 
Nervous system disorders     
Dizziness *  33/296 (11.15%)  28/299 (9.36%) 
Insomina *  33/296 (11.15%)  39/299 (13.04%) 
Nervousness *  21/296 (7.09%)  10/299 (3.34%) 
Sommolence *  42/296 (14.19%)  48/299 (16.05%) 
Renal and urinary disorders     
Urogenitial *  24/296 (8.11%)  25/299 (8.36%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory *  29/296 (9.80%)  28/299 (9.36%) 
Skin and subcutaneous tissue disorders     
Sweating *  43/296 (14.53%)  33/299 (11.04%) 
Vascular disorders     
Vasodilatation *  12/296 (4.05%)  16/299 (5.35%) 
*
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
Layout table for Results Point of Contact information
Name/Title: U. S. Contact Center
Organization: Wyeth
EMail: clintrialresults@wyeth.com
Layout table for additonal information
Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00406640     History of Changes
Other Study ID Numbers: 3151A1-402
First Submitted: November 29, 2006
First Posted: December 4, 2006
Results First Submitted: February 27, 2009
Results First Posted: June 29, 2010
Last Update Posted: June 29, 2010