Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00863798

Recruitment Status : Completed

First Posted : March 18, 2009

Results First Posted : May 6, 2011

Last Update Posted : May 6, 2011

Sponsor:

Collaborator:

Pfizer

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Major Depressive Disorder
Interventions	Drug: Desvenlafaxine Succinate Sustained-Release 10mg Drug: Desvenlafaxine Succinate Sustained-Release 50 mg Drug: placebo
Enrollment	682

Participant Flow

Recruitment Details
Pre-assignment Details	A total of 898 potential participants were screened for this study. 804 participants were enrolled and received single-blind placebo during the screening period prior to randomization.


Arm/Group Title	Placebo	DVS SR 10 mg	DVS SR 50 mg
Arm/Group Description	Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...
Arm/Group Description	Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Period Title: Overall Study
Started	227	228	227
Treated	223	226	224
Completed	195	198	202
Not Completed	32	30	25
Reason Not Completed
Adverse Event	5	2	4
Participant failed to return	2	1	0
Investigator request	1	2	1
Lack of Efficacy	4	3	6
Lost to Follow-up	6	9	5
Other	2	3	1
Protocol Violation	0	1	1
Withdrawal by Subject	8	7	4
Randomized not treated	4	2	3

Baseline Characteristics

Arm/Group Title		Placebo	DVS SR 10 mg	DVS SR 50 mg	Total
Arm/Group Description		Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...	Total of all reporting groups
Arm/Group Description		Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.	Total of all reporting groups
Overall Number of Baseline Participants		223	226	224	673
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	223 participants	226 participants	224 participants	673 participants
		41.75 (12.85)	41.01 (13.75)	42.47 (13.47)	41.74 (13.36)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	223 participants	226 participants	224 participants	673 participants
	Female	139 62.3%	135 59.7%	135 60.3%	409 60.8%
	Male	84 37.7%	91 40.3%	89 39.7%	264 39.2%
Hamilton Psychiatric Scale for Depression-17 item HAM-D17) total score ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	223 participants	226 participants	224 participants	673 participants
		23.23 (2.63)	22.83 (2.26)	23.12 (2.62)	23.06 (2.51)
		[1] Measure 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.
Clinical Global Impressions Scale-Severity of Illness (CGI-S) Score ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	223 participants	226 participants	224 participants	673 participants
		4.14 (0.35)	4.14 (0.34)	4.16 (0.39)	4.14 (0.36)
		[1] Measure 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 patients). Higher score = more affected.
Montgomery-Asberg Depression Rating Scale (MADRS) total score ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	223 participants	226 participants	224 participants	673 participants
		28.33 (4.71)	27.59 (4.49)	28.44 (4.83)	28.12 (4.69)
		[1] Measure 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).
HAM-D6 total score ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	223 participants	226 participants	224 participants	673 participants
		12.72 (1.51)	12.77 (1.41)	12.63 (1.49)	12.71 (1.47)
		[1] Measure Description: HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items associated with major depression and is a subset of the 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 and all others are scored 0-4.
Sheehan Disability Scale (SDS) Total Score ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	223 participants	226 participants	224 participants	673 participants
		16.88 (8.25)	16.42 (8.37)	17.06 (7.73)	16.78 (8.12)
		[1] Measure Description: SDS: a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities.Participant rates extent to which each of these domains are impaired by his/her symptoms using 10 point visual analog scale:(0=not at all impaired,10=extremely impaired) for total maximum score of 30.
World Health Organization 5-Item Well-Being Index (WHO-5) ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	223 participants	226 participants	224 participants	673 participants
		7.39 (4.80)	7.47 (4.86)	7.06 (4.26)	7.31 (4.65)
		[1] Measure Description: WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 ( 0= worst possible quality of life; 25=best possible quality of life).
Participants with Sexual dysfunction ^[1] Measure Type: Number Unit of measure: Percentage of Participants
	Number Analyzed	223 participants	226 participants	224 participants	673 participants
		58.8	61.3	65.8	185.9
		[1] Measure Description: Arizona Sexual Experiences Scale (ASEX) includes 5 questions that evaluate sexual function exclusively during week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items.
Participants with Columbia Suicide-Severity Rating Scale (C-SSRS) total score ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	223 participants	226 participants	224 participants	673 participants
Completed Suicide		0	0	0	0
Suicide Attempt		0	0	0	0
Preparatory acts toward imminent suicidal behavior		0	0	0	0
Suicidal ideation		37	31	29	97
		[1] Measure Description: C-SSRS was mapped into Columbia Classification Algorithm of Suicide Assessment (C-CASA)(1-4) to prospectively assess whether participants experienced: completed suicide(1),suicide attempt(2),preparatory acts toward imminent suicidal behavior(3),suicidal ideation,any suicidal behavior and ideation(4).Participants with "yes" response were reported.

Outcome Measures

1.Primary Outcome


Title	Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET)
Description	HAM-D17: a standardized, clinician-administered rating scale that asse...
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 ET)

Outcome Measure Data

Analysis Population Description

Intent-To-Treat (ITT) Population:all randomly assigned participants with baseline primary efficacy evaluation, had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, last observation carried forward (LOCF) method of imputation was used.


Arm/Group Title	Placebo	DVS SR 10 mg	DVS SR 50 mg
Arm/Group Description:	Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...
Arm/Group Description:	Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed	223	226	224
Mean (Standard Error) Unit of Measure: Units on a scale
	-8.42 (0.45)	-9.28 (0.45)	-8.92 (0.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare DVS SR 10 mg to placebo. The comparison was performed at the 0.05 level overall.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.175
	Comments	A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95% -0.38 to 2.10
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare DVS SR 10 mg to placebo. The comparison was performed at the 0.05 level overall.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.421
	Comments	A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.51
	Confidence Interval	(2-Sided) 95% -0.73 to 1.75
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)
Description	CGI-I: 7-point clinician rated scale ranging from 1 (very much improve...
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. Higher score = more affected.
Time Frame	Week 8 (or ET)

Outcome Measure Data

Analysis Population Description

ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.


Arm/Group Title	Placebo	DVS SR 10 mg	DVS SR 50 mg
Arm/Group Description:	Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...
Arm/Group Description:	Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed	223	226	224
Measure Type: Number Unit of Measure: Participants
1=Very much improved	49	50	55
2=Much improved	54	75	53
3=Minimally improved	51	51	64
4=No change	61	46	49
5=Minimally worse	5	4	3
6=Much worse	3	0	0
7=Very much worse	0	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.076
	Comments	In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.204
	Comments	In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

3.Secondary Outcome


Title	Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)
Description	CGI-S: 7-point clinician rated scale to assess severity of participant...
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 patients). Higher score = more affected.
Time Frame	Baseline and Week 8 (or ET )

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Placebo	DVS SR 10 mg	DVS SR 50 mg
Arm/Group Description:	Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...
Arm/Group Description:	Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed	223	226	224
Mean (Standard Error) Unit of Measure: Units on a scale
	-1.08 (0.07)	-1.23 (0.07)	-1.11 (0.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.130
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 95% -0.04 to 0.35
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.757
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 95% -0.16 to 0.23
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)
Description	MADRS measures the overall severity of depressive symptoms. The MADRS ...
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 ET)

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Placebo	DVS SR 10 mg	DVS SR 50 mg
Arm/Group Description:	Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...
Arm/Group Description:	Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed	222	224	222
Mean (Standard Error) Unit of Measure: Units on a scale
	-9.87 (0.63)	-11.28 (0.63)	-10.76 (0.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.114
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	1.41
	Confidence Interval	(2-Sided) 95% -0.34 to 3.16
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.316
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95% -0.85 to 2.64
	Estimation Comments	[Not Specified]

5.Secondary Outcome


Title	Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)
Description	HAM-D6: a standardized, clinician-administered rating scale that asses...
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. 0=none/absent and 22=most severe.The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.
Time Frame	Baseline and Week 8 (or ET )

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Placebo	DVS SR 10 mg	DVS SR 50 mg
Arm/Group Description:	Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...
Arm/Group Description:	Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed	223	226	224
Mean (Standard Error) Unit of Measure: Units on a scale
	-4.75 (0.27)	-5.49 (0.27)	-5.19 (0.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.054
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 95% -0.01 to 1.50
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.253
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.44
	Confidence Interval	(2-Sided) 95% -0.32 to 1.20
	Estimation Comments	[Not Specified]

6.Secondary Outcome


Title	Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)
Description	A HAM-D17 responder was defined as a participant with a 50% or greater...
Description	A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in 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 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	Week 8 (or ET)

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Placebo	DVS SR 10 mg	DVS SR 50 mg
Arm/Group Description:	Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...
Arm/Group Description:	Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed	223	226	224
Measure Type: Number Unit of Measure: Participants
	85	100	91

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.2415
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.254
	Confidence Interval	(2-Sided) 95% 0.86 to 1.83
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6169
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.102
	Confidence Interval	(2-Sided) 95% 0.75 to 1.61
	Estimation Comments	[Not Specified]

7.Secondary Outcome


Title	Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)
Description	Remission was defined as a HAM-D17 score of less than or equal to 7. H...
Description	Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual 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	Week 8 (or ET)

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Placebo	DVS SR 10 mg	DVS SR 50 mg
Arm/Group Description:	Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...
Arm/Group Description:	Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed	223	226	224
Measure Type: Number Unit of Measure: Participants
	42	52	39

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3667
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.236
	Confidence Interval	(2-Sided) 95% 0.78 to 1.96
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6509
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.894
	Confidence Interval	(2-Sided) 95% 0.55 to 1.45
	Estimation Comments	[Not Specified]

8.Secondary Outcome


Title	Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)
Description	A MADRS responder was defined as a participant with a 50% or greater d...
Description	A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It 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	Week 8 (or ET)

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Placebo	DVS SR 10 mg	DVS SR 50 mg
Arm/Group Description:	Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...
Arm/Group Description:	Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed	222	224	222
Measure Type: Number Unit of Measure: Participants
	84	95	90

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	Analysis would be conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3893
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.182
	Confidence Interval	(2-Sided) 95% 0.81 to 1.73
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	Analysis would be conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.5510
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.123
	Confidence Interval	(2-Sided) 95% 0.77 to 1.65
	Estimation Comments	[Not Specified]

9.Secondary Outcome


Title	Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)
Description	CGI-I responder was defined as a participant with a score of 1 (very m...
Description	CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. 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. Higher score = more affected.
Time Frame	Week 8 (or ET)

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Placebo	DVS SR 10 mg	DVS SR 50 mg
Arm/Group Description:	Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...
Arm/Group Description:	Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed	223	226	224
Measure Type: Number Unit of Measure: Participants
	103	125	108

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	Analysis would be conducted with a logistic regression model with treatment as a factor.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0536
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.442
	Confidence Interval	(2-Sided) 95% 0.99 to 2.09
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	Analysis would be conducted with a logistic regression model with treatment as a factor.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6679
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.085
	Confidence Interval	(2-Sided) 95% 0.75 to 1.57
	Estimation Comments	[Not Specified]

10.Other Pre-specified Outcome


Title	Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations
Description	Relationship of demographic variables (age, gender, food, race, creati...
Description	Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.
Time Frame	Week 2, 4 and 8 (or ET)

Outcome Measure Data

Analysis Population Description

PK population; data was insufficient examine the effect of demographic variables on the PK of desvenlafaxine. Parameter values were calculated for variables altering CL/F, AUC and V/F. Population parameters from nonlinear mixed effects modeling were not summarized as descriptive statistics.


Arm/Group Title	Placebo	DVS SR 10 mg	DVS SR 50 mg
Arm/Group Description:	Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...
Arm/Group Description:	Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

11.Other Pre-specified Outcome


Title	Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)
Description	SDS: a self-administered tools that measures functional impairment in ...
Description	SDS: a self-administered tools that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.
Time Frame	Baseline and Week 8 (or ET)

Outcome Measure Data

Analysis Population Description

ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation,had taken at least 1 dose of double-blind study drug,had at least 1 primary efficacy evaluation after first dose of double-blind drug.'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.


Arm/Group Title	Placebo	DVS SR 10 mg	DVS SR 50 mg
Arm/Group Description:	Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...
Arm/Group Description:	Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed	223	226	224
Mean (Standard Error) Unit of Measure: Units on a scale
Total Score (n=220,223,219)	-2.63 (0.48)	-4.09 (0.48)	-3.78 (0.49)
Work/Studies Component(n=220,223,219)	-0.61 (0.17)	-1.10 (0.17)	-1.14 (0.17)
Social Life and Leisure Activities(n=222,224,221)	-1.08 (0.18)	-1.58 (0.17)	-1.36 (0.18)
Family Life/Home Responsibilities (n=222,224,221)	-0.98 (0.17)	-1.43 (0.17)	-1.20 (0.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for "total score".
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.033
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.46
	Confidence Interval	(2-Sided) 95% 0.12 to 2.79
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for "total score".
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.096
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.15
	Confidence Interval	(2-Sided) 95% -0.20 to 2.49
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for "work/studies component score".
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.043
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.48
	Confidence Interval	(2-Sided) 95% 0.02 to 0.95
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for "work/studies component score".
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.027
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.53
	Confidence Interval	(2-Sided) 95% 0.06 to 1.00
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for "social life and leisure activities component score".
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.045
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.50
	Confidence Interval	(2-Sided) 95% 0.01 to 0.98
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for "social life and leisure activities component score".
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.277
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.27
	Confidence Interval	(2-Sided) 95% -0.22 to 0.76
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for "family life/home responsibilities component score".
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.056
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.45
	Confidence Interval	(2-Sided) 95% -0.01 to 0.91
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for "family life/home responsibilities component score".
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.355
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 95% -0.24 to 0.68
	Estimation Comments	[Not Specified]

12.Other Pre-specified Outcome


Title	Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)
Description	WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5...
Description	WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).
Time Frame	Baseline and Week 8 (or ET)

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Placebo	DVS SR 10 mg	DVS SR 50 mg
Arm/Group Description:	Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...
Arm/Group Description:	Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed	222	224	221
Mean (Standard Error) Unit of Measure: Units on a scale
	2.96 (0.36)	4.51 (0.35)	3.73 (0.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.54
	Confidence Interval	(2-Sided) 95% -2.53 to -0.56
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.129
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.77
	Confidence Interval	(2-Sided) 95% -1.75 to 0.22
	Estimation Comments	[Not Specified]

13.Other Pre-specified Outcome


Title	Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)
Description	ASEX scale includes 5 questions that evaluate sexual function exclusiv...
Description	ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week were instructed to not complete questions 3 through 5.
Time Frame	Week 8 (or ET)

Outcome Measure Data

Analysis Population Description

The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.


Arm/Group Title	Placebo	DVS SR 10 mg	DVS SR 50 mg
Arm/Group Description:	Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...
Arm/Group Description:	Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed	221	222	220
Measure Type: Number Unit of Measure: Percentage of Participants
	52.0	48.6	59.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3097
	Comments	[Not Specified]
	Method	Regression, Linear
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.800
	Confidence Interval	(2-Sided) 95% 0.52 to 1.23
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.2794
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.272
	Confidence Interval	(2-Sided) 95% 0.82 to 1.97
	Estimation Comments	[Not Specified]

14.Other Pre-specified Outcome


Title	Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)
Description	C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed...
Description	C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of "Yes" on "Actual Attempt"),preparatory acts toward imminent suicidal behavior (3)("Yes" on "Preparatory Acts or Behavior"),suicidal ideation (4)("Yes" on "Wish to be dead","Non-Specific Active Suicidal Thoughts","Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)("Yes" on "Has subject engaged in Non-suicidal Self-Injurious Behavior").
Time Frame	Week 8 (or ET)

Outcome Measure Data

Analysis Population Description

The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.


Arm/Group Title	Placebo	DVS SR 10 mg	DVS SR 50 mg
Arm/Group Description:	Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...
Arm/Group Description:	Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed	223	226	224
Measure Type: Number Unit of Measure: Participants
Completed suicide	0	0	0
Suicide attempt	0	1	0
Preparatory acts toward imminent suicidal behavior	0	0	1
Suicidal ideation	56	43	45
Any suicidal behavior and/or ideation	56	43	45
Self-injurious behavior, no suicidal intent	1	0	0

15.Other Pre-specified Outcome


Title	Discontinuation-Emergent Signs and Symptoms (DESS)
Description	DESS: a clinician-administered 43-item assessment that evaluates disco...
Description	DESS: 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.
Time Frame	Week 8 to 10 (or ET)

Outcome Measure Data

Analysis Population Description

Analysis included completers for exposure (those whose exposure duration was at least 53 days) among safety population. 'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.


Arm/Group Title	Placebo	DVS SR 10 mg	DVS SR 50 mg
Arm/Group Description:	Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...
Arm/Group Description:	Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.
Overall Number of Participants Analyzed	223	226	224
Mean (Standard Deviation) Unit of Measure: Units on a scale
Week 8 (or ET) (n=190,194,191)	0.72 (1.81)	0.80 (1.78)	0.83 (2.05)
Week 9 ( or ET + 1 week) (n=178,185,186)	1.26 (2.78)	1.08 (2.31)	1.98 (3.29)
Week 10 (or ET + 2 weeks (n=170,182,182)	0.90 (2.30)	0.91 (2.24)	1.07 (2.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 8.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.805
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 9.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.805
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 10 mg
	Comments	To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 10.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.978
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 8.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.805
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 9.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.154
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, DVS SR 50 mg
	Comments	To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 10.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.805
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
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 10 mg	DVS SR 50 mg
Arm/Group Description	Matching placebo tablets daily unti...	Desvenlafaxine Succinate Sustained ...	DVS SR 50 mg daily until Day 56 (We...
Arm/Group Description	Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).	Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.	DVS SR 50 mg daily until Day 56 (Week 8) or ET.
All-Cause Mortality
	Placebo	DVS SR 10 mg	DVS SR 50 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Placebo	DVS SR 10 mg	DVS SR 50 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/223 (1.35%)	1/226 (0.44%)	1/224 (0.45%)
General disorders
Non-cardiac chest pain ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Infections and infestations
Appendicitis ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Scrotal abscess ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Renal and urinary disorders
Urinary retention ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Reproductive system and breast disorders
Epididymitis ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Placebo	DVS SR 10 mg	DVS SR 50 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	166/223 (74.44%)	168/226 (74.34%)	170/224 (75.89%)
Blood and lymphatic system disorders
Leukocytosis ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Lymphadenopathy ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Polycythaemia ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Cardiac disorders
Atrioventricular block first degree ^* 1	2/223 (0.90%)	0/226 (0.00%)	1/224 (0.45%)
Bradycardia ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Cardiac hypertrophy ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Palpitations ^* 1	1/223 (0.45%)	5/226 (2.21%)	1/224 (0.45%)
Supraventricular extrasystoles ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Tachycardia ^* 1	2/223 (0.90%)	1/226 (0.44%)	4/224 (1.79%)
Ventricular extrasystoles ^* 1	2/223 (0.90%)	1/226 (0.44%)	1/224 (0.45%)
Ear and labyrinth disorders
Ear discomfort ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Ear pain ^* 1	1/223 (0.45%)	1/226 (0.44%)	2/224 (0.89%)
Hyperacusis ^* 1	1/223 (0.45%)	0/226 (0.00%)	1/224 (0.45%)
Tinnitus ^* 1	1/223 (0.45%)	0/226 (0.00%)	2/224 (0.89%)
Vertigo ^* 1	0/223 (0.00%)	1/226 (0.44%)	1/224 (0.45%)
Eye disorders
Blepharospasm ^* 1	2/223 (0.90%)	0/226 (0.00%)	1/224 (0.45%)
Conjunctivitis ^* 1	0/223 (0.00%)	0/226 (0.00%)	3/224 (1.34%)
Diabetic retinopathy ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Dry eye ^* 1	0/223 (0.00%)	1/226 (0.44%)	1/224 (0.45%)
Excessive eye blinking ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Eye pain ^* 1	2/223 (0.90%)	2/226 (0.88%)	1/224 (0.45%)
Eye pruritus ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Miosis ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Photophobia ^* 1	0/223 (0.00%)	1/226 (0.44%)	1/224 (0.45%)
Photopsia ^* 1	1/223 (0.45%)	1/226 (0.44%)	0/224 (0.00%)
Vision blurred ^* 1	3/223 (1.35%)	3/226 (1.33%)	4/224 (1.79%)
Visual impairment ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Gastrointestinal disorders
Abdominal discomfort ^* 1	2/223 (0.90%)	2/226 (0.88%)	2/224 (0.89%)
Abdominal distension ^* 1	4/223 (1.79%)	4/226 (1.77%)	4/224 (1.79%)
Abdominal pain ^* 1	2/223 (0.90%)	5/226 (2.21%)	4/224 (1.79%)
Abdominal pain upper ^* 1	6/223 (2.69%)	3/226 (1.33%)	3/224 (1.34%)
Chapped lips ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Constipation ^* 1	7/223 (3.14%)	8/226 (3.54%)	15/224 (6.70%)
Dental caries ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Diarrhoea ^* 1	17/223 (7.62%)	20/226 (8.85%)	19/224 (8.48%)
Diverticulum ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Dry mouth ^* 1	13/223 (5.83%)	20/226 (8.85%)	25/224 (11.16%)
Dyspepsia ^* 1	7/223 (3.14%)	6/226 (2.65%)	9/224 (4.02%)
Eructation ^* 1	0/223 (0.00%)	3/226 (1.33%)	0/224 (0.00%)
Faecaloma ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Faeces discoloured ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Faeces pale ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Flatulence ^* 1	7/223 (3.14%)	5/226 (2.21%)	2/224 (0.89%)
Food poisoning ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Frequent bowel movements ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Gastritis ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Gastrooesophageal reflux disease ^* 1	1/223 (0.45%)	2/226 (0.88%)	1/224 (0.45%)
Haematochezia ^* 1	0/223 (0.00%)	0/226 (0.00%)	2/224 (0.89%)
Nausea ^* 1	21/223 (9.42%)	26/226 (11.50%)	42/224 (18.75%)
Pancreatic cyst ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Salivary hypersecretion ^* 1	2/223 (0.90%)	2/226 (0.88%)	1/224 (0.45%)
Toothache ^* 1	2/223 (0.90%)	0/226 (0.00%)	5/224 (2.23%)
Umbilical hernia ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Vomiting ^* 1	5/223 (2.24%)	9/226 (3.98%)	6/224 (2.68%)
Vomiting in pregnancy ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
General disorders
Asthenia ^* 1	2/223 (0.90%)	1/226 (0.44%)	0/224 (0.00%)
Chest discomfort ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Chest pain ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Chills ^* 1	2/223 (0.90%)	0/226 (0.00%)	2/224 (0.89%)
Fatigue ^* 1	8/223 (3.59%)	10/226 (4.42%)	16/224 (7.14%)
Feeling abnormal ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Feeling jittery ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Inflammation ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Influenza like illness ^* 1	1/223 (0.45%)	2/226 (0.88%)	4/224 (1.79%)
Injection site pruritus ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Irritability ^* 1	12/223 (5.38%)	8/226 (3.54%)	8/224 (3.57%)
Non-cardiac chest pain ^* 1	0/223 (0.00%)	1/226 (0.44%)	3/224 (1.34%)
Oedema peripheral ^* 1	1/223 (0.45%)	2/226 (0.88%)	0/224 (0.00%)
Pain ^* 1	2/223 (0.90%)	0/226 (0.00%)	0/224 (0.00%)
Pyrexia ^* 1	0/223 (0.00%)	0/226 (0.00%)	4/224 (1.79%)
Temperature intolerance ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Thirst ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Immune system disorders
Seasonal allergy ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Infections and infestations
Acarodermatitis ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Acute sinusitis ^* 1	0/223 (0.00%)	1/226 (0.44%)	1/224 (0.45%)
Bronchitis ^* 1	3/223 (1.35%)	2/226 (0.88%)	3/224 (1.34%)
Bronchitis viral ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Cellulitis ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Ear infection ^* 1	1/223 (0.45%)	0/226 (0.00%)	1/224 (0.45%)
Folliculitis ^* 1	1/223 (0.45%)	0/226 (0.00%)	1/224 (0.45%)
Gastroenteritis ^* 1	1/223 (0.45%)	4/226 (1.77%)	2/224 (0.89%)
Gastroenteritis viral ^* 1	1/223 (0.45%)	4/226 (1.77%)	1/224 (0.45%)
Gingival infection ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
H1N1 influenza ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Infected bites ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Infected cyst ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Influenza ^* 1	7/223 (3.14%)	8/226 (3.54%)	5/224 (2.23%)
Meningitis viral ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Nasopharyngitis ^* 1	6/223 (2.69%)	5/226 (2.21%)	7/224 (3.13%)
Otitis media ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Pharyngitis ^* 1	3/223 (1.35%)	3/226 (1.33%)	1/224 (0.45%)
Pharyngitis streptococcal ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Pneumonia ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Pyelonephritis ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Respiratory tract infection viral ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Rhinitis ^* 1	2/223 (0.90%)	0/226 (0.00%)	2/224 (0.89%)
Sinusitis ^* 1	2/223 (0.90%)	3/226 (1.33%)	2/224 (0.89%)
Tonsillitis ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Tooth abscess ^* 1	2/223 (0.90%)	1/226 (0.44%)	0/224 (0.00%)
Tooth infection ^* 1	2/223 (0.90%)	0/226 (0.00%)	0/224 (0.00%)
Upper respiratory tract infection ^* 1	17/223 (7.62%)	21/226 (9.29%)	16/224 (7.14%)
Urinary tract infection ^* 1	4/223 (1.79%)	1/226 (0.44%)	1/224 (0.45%)
Vaginitis bacterial ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Viral infection ^* 1	4/223 (1.79%)	1/226 (0.44%)	1/224 (0.45%)
Viral upper respiratory tract infection ^* 1	0/223 (0.00%)	2/226 (0.88%)	0/224 (0.00%)
Vulvovaginal candidiasis ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Vulvovaginal mycotic infection ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Injury, poisoning and procedural complications
Ankle fracture ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Arthropod sting ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Back injury ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Contusion ^* 1	2/223 (0.90%)	0/226 (0.00%)	2/224 (0.89%)
Epicondylitis ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Excoriation ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Fall ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Intentional overdose ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Joint injury ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Joint sprain ^* 1	2/223 (0.90%)	1/226 (0.44%)	2/224 (0.89%)
Ligament rupture ^* 1	1/223 (0.45%)	1/226 (0.44%)	0/224 (0.00%)
Limb injury ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Meniscus lesion ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Muscle strain ^* 1	2/223 (0.90%)	1/226 (0.44%)	0/224 (0.00%)
Procedural pain ^* 1	1/223 (0.45%)	0/226 (0.00%)	1/224 (0.45%)
Road traffic accident ^* 1	0/223 (0.00%)	0/226 (0.00%)	2/224 (0.89%)
Skin laceration ^* 1	2/223 (0.90%)	0/226 (0.00%)	1/224 (0.45%)
Tooth fracture ^* 1	0/223 (0.00%)	0/226 (0.00%)	3/224 (1.34%)
Upper limb fracture ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Investigations
Alanine aminotransferase increased ^* 1	1/223 (0.45%)	1/226 (0.44%)	2/224 (0.89%)
Aspartate aminotransferase increased ^* 1	1/223 (0.45%)	1/226 (0.44%)	0/224 (0.00%)
Blood alkaline phosphatase increased ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Blood bilirubin increased ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Blood calcium increased ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Blood glucose increased ^* 1	1/223 (0.45%)	1/226 (0.44%)	0/224 (0.00%)
Blood human chorionic gonadotropin ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Blood pressure decreased ^* 1	0/223 (0.00%)	2/226 (0.88%)	0/224 (0.00%)
Blood pressure diastolic decreased ^* 1	1/223 (0.45%)	1/226 (0.44%)	1/224 (0.45%)
Blood pressure diastolic increased ^* 1	1/223 (0.45%)	2/226 (0.88%)	0/224 (0.00%)
Blood pressure increased ^* 1	0/223 (0.00%)	1/226 (0.44%)	4/224 (1.79%)
Blood pressure orthostatic decreased ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Blood pressure systolic decreased ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Blood prolactin increased ^* 1	1/223 (0.45%)	0/226 (0.00%)	1/224 (0.45%)
Blood triglycerides increased ^* 1	2/223 (0.90%)	1/226 (0.44%)	0/224 (0.00%)
Body temperature increased ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Electrocardiogram T wave amplitude decreased ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Electrocardiogram T wave inversion ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Heart rate increased ^* 1	0/223 (0.00%)	3/226 (1.33%)	1/224 (0.45%)
Heart rate irregular ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Hepatic enzyme increased ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Liver function test abnormal ^* 1	1/223 (0.45%)	2/226 (0.88%)	1/224 (0.45%)
Neutrophil count decreased ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Platelet count decreased ^* 1	1/223 (0.45%)	1/226 (0.44%)	0/224 (0.00%)
Platelet count increased ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Protein urine ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Tuberculin test positive ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Weight decreased ^* 1	3/223 (1.35%)	1/226 (0.44%)	1/224 (0.45%)
Weight increased ^* 1	2/223 (0.90%)	1/226 (0.44%)	3/224 (1.34%)
White blood cell count decreased ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Metabolism and nutrition disorders
Alcohol intolerance ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Decreased appetite ^* 1	9/223 (4.04%)	10/226 (4.42%)	20/224 (8.93%)
Fluid retention ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Food craving ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Glucose tolerance impaired ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Hypercalcaemia ^* 1	0/223 (0.00%)	2/226 (0.88%)	0/224 (0.00%)
Hyperkalaemia ^* 1	0/223 (0.00%)	1/226 (0.44%)	1/224 (0.45%)
Hypernatraemia ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Hyperphagia ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Hyperproteinaemia ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Increased appetite ^* 1	4/223 (1.79%)	2/226 (0.88%)	0/224 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^* 1	3/223 (1.35%)	4/226 (1.77%)	1/224 (0.45%)
Arthritis ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Back pain ^* 1	3/223 (1.35%)	3/226 (1.33%)	5/224 (2.23%)
Costochondritis ^* 1	1/223 (0.45%)	1/226 (0.44%)	0/224 (0.00%)
Fibromyalgia ^* 1	1/223 (0.45%)	1/226 (0.44%)	0/224 (0.00%)
Flank pain ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Joint stiffness ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Joint swelling ^* 1	1/223 (0.45%)	2/226 (0.88%)	1/224 (0.45%)
Muscle spasms ^* 1	1/223 (0.45%)	4/226 (1.77%)	4/224 (1.79%)
Muscle tightness ^* 1	4/223 (1.79%)	0/226 (0.00%)	1/224 (0.45%)
Muscle twitching ^* 1	1/223 (0.45%)	1/226 (0.44%)	0/224 (0.00%)
Musculoskeletal chest pain ^* 1	1/223 (0.45%)	1/226 (0.44%)	0/224 (0.00%)
Musculoskeletal discomfort ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Musculoskeletal pain ^* 1	1/223 (0.45%)	1/226 (0.44%)	1/224 (0.45%)
Musculoskeletal stiffness ^* 1	2/223 (0.90%)	2/226 (0.88%)	1/224 (0.45%)
Myalgia ^* 1	7/223 (3.14%)	5/226 (2.21%)	6/224 (2.68%)
Myokymia ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Neck pain ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Pain in extremity ^* 1	1/223 (0.45%)	5/226 (2.21%)	1/224 (0.45%)
Plantar fasciitis ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Rotator cuff syndrome ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Sensation of heaviness ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Melanocytic naevus ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Nervous system disorders
Akathisia ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Cognitive disorder ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Crying ^* 1	2/223 (0.90%)	1/226 (0.44%)	3/224 (1.34%)
Diabetic neuropathy ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Disturbance in attention ^* 1	1/223 (0.45%)	7/226 (3.10%)	3/224 (1.34%)
Dizziness ^* 1	17/223 (7.62%)	11/226 (4.87%)	29/224 (12.95%)
Dizziness postural ^* 1	1/223 (0.45%)	2/226 (0.88%)	5/224 (2.23%)
Drug withdrawal headache ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Dysgeusia ^* 1	1/223 (0.45%)	0/226 (0.00%)	2/224 (0.89%)
Dyskinesia ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Exaggerated startle response ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Headache ^* 1	23/223 (10.31%)	32/226 (14.16%)	24/224 (10.71%)
Hypersomnia ^* 1	0/223 (0.00%)	2/226 (0.88%)	1/224 (0.45%)
Hypoaesthesia ^* 1	0/223 (0.00%)	0/226 (0.00%)	2/224 (0.89%)
Hypogeusia ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Lethargy ^* 1	2/223 (0.90%)	0/226 (0.00%)	0/224 (0.00%)
Loss of consciousness ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Memory impairment ^* 1	1/223 (0.45%)	1/226 (0.44%)	1/224 (0.45%)
Migraine ^* 1	2/223 (0.90%)	0/226 (0.00%)	3/224 (1.34%)
Paraesthesia ^* 1	4/223 (1.79%)	3/226 (1.33%)	5/224 (2.23%)
Poor quality sleep ^* 1	1/223 (0.45%)	1/226 (0.44%)	0/224 (0.00%)
Presyncope ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Restless legs syndrome ^* 1	3/223 (1.35%)	1/226 (0.44%)	1/224 (0.45%)
Sedation ^* 1	1/223 (0.45%)	1/226 (0.44%)	1/224 (0.45%)
Sinus headache ^* 1	1/223 (0.45%)	1/226 (0.44%)	4/224 (1.79%)
Somnolence ^* 1	12/223 (5.38%)	10/226 (4.42%)	13/224 (5.80%)
Syncop ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Tension headache ^* 1	8/223 (3.59%)	7/226 (3.10%)	11/224 (4.91%)
Tremor ^* 1	5/223 (2.24%)	3/226 (1.33%)	2/224 (0.89%)
Pregnancy, puerperium and perinatal conditions
Pregnancy ^* 1	1/223 (0.45%)	2/226 (0.88%)	1/224 (0.45%)
Psychiatric disorders
Abnormal dreams ^* 1	8/223 (3.59%)	11/226 (4.87%)	14/224 (6.25%)
Agitation ^* 1	0/223 (0.00%)	0/226 (0.00%)	2/224 (0.89%)
Anger ^* 1	0/223 (0.00%)	1/226 (0.44%)	2/224 (0.89%)
Anorgasmia ^* 1	0/223 (0.00%)	2/226 (0.88%)	3/224 (1.34%)
Anxiety ^* 1	6/223 (2.69%)	7/226 (3.10%)	7/224 (3.13%)
Bradyphrenia ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Bruxism ^* 1	1/223 (0.45%)	2/226 (0.88%)	0/224 (0.00%)
Depersonalisation ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Depressed mood ^* 1	0/223 (0.00%)	1/226 (0.44%)	1/224 (0.45%)
Depression ^* 1	1/223 (0.45%)	8/226 (3.54%)	0/224 (0.00%)
Derealisation ^* 1	1/223 (0.45%)	0/226 (0.00%)	1/224 (0.45%)
Disorientation ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Dissociation ^* 1	2/223 (0.90%)	3/226 (1.33%)	1/224 (0.45%)
Distractibility ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Elevated mood ^* 1	2/223 (0.90%)	0/226 (0.00%)	0/224 (0.00%)
Impulse-control disorder ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Initial insomnia ^* 1	2/223 (0.90%)	1/226 (0.44%)	5/224 (2.23%)
Insomnia ^* 1	14/223 (6.28%)	16/226 (7.08%)	20/224 (8.93%)
Libido decreased ^* 1	5/223 (2.24%)	5/226 (2.21%)	6/224 (2.68%)
Loss of libido ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Major depression ^* 1	2/223 (0.90%)	0/226 (0.00%)	0/224 (0.00%)
Middle insomnia ^* 1	1/223 (0.45%)	5/226 (2.21%)	5/224 (2.23%)
Mood altered ^* 1	0/223 (0.00%)	2/226 (0.88%)	3/224 (1.34%)
Mood swings ^* 1	1/223 (0.45%)	1/226 (0.44%)	2/224 (0.89%)
Nervousness ^* 1	0/223 (0.00%)	1/226 (0.44%)	1/224 (0.45%)
Nightmare ^* 1	0/223 (0.00%)	6/226 (2.65%)	4/224 (1.79%)
Orgasm abnormal ^* 1	1/223 (0.45%)	2/226 (0.88%)	2/224 (0.89%)
Orgasmic sensation decreased ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Panic attack ^* 1	1/223 (0.45%)	3/226 (1.33%)	0/224 (0.00%)
Panic disorder ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Restlessness ^* 1	1/223 (0.45%)	1/226 (0.44%)	2/224 (0.89%)
Self injurious behaviour ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Suicidal ideation ^* 1	5/223 (2.24%)	3/226 (1.33%)	6/224 (2.68%)
Suicide attempt ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Tearfulness ^* 1	1/223 (0.45%)	3/226 (1.33%)	4/224 (1.79%)
Terminal insomnia ^* 1	2/223 (0.90%)	0/226 (0.00%)	3/224 (1.34%)
Withdrawal syndrome ^* 1	8/223 (3.59%)	12/226 (5.31%)	16/224 (7.14%)
Renal and urinary disorders
Chromaturia ^* 1	0/223 (0.00%)	1/226 (0.44%)	1/224 (0.45%)
Haematuria ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Incontinence ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Micturition urgency ^* 1	1/223 (0.45%)	1/226 (0.44%)	0/224 (0.00%)
Nephrolithiasis ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Pollakiuria ^* 1	0/223 (0.00%)	3/226 (1.33%)	2/224 (0.89%)
Polyuria ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Proteinuria ^* 1	0/223 (0.00%)	1/226 (0.44%)	2/224 (0.89%)
Urge incontinence ^* 1	2/223 (0.90%)	0/226 (0.00%)	0/224 (0.00%)
Urinary hesitation ^* 1	0/223 (0.00%)	0/226 (0.00%)	4/224 (1.79%)
Urine odour abnormal ^* 1	1/223 (0.45%)	0/226 (0.00%)	1/224 (0.45%)
Reproductive system and breast disorders
Breast enlargement ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Breast mass ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Breast tenderness ^* 1	2/223 (0.90%)	1/226 (0.44%)	0/224 (0.00%)
Dysmenorrhoea ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Ejaculation delayed ^* 1	1/223 (0.45%)	2/226 (0.88%)	2/224 (0.89%)
Erectile dysfunction ^* 1	0/223 (0.00%)	2/226 (0.88%)	3/224 (1.34%)
Menorrhagia ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Menstruation irregular ^* 1	1/223 (0.45%)	1/226 (0.44%)	1/224 (0.45%)
Metrorrhagia ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Oligomenorrhoea ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Pelvic pain ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Prostatomegaly ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Sexual dysfunction ^* 1	0/223 (0.00%)	0/226 (0.00%)	2/224 (0.89%)
Spontaneous penile erection ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Vaginal discharge ^* 1	1/223 (0.45%)	0/226 (0.00%)	1/224 (0.45%)
Vaginal odour ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Respiratory, thoracic and mediastinal disorders
Asthma ^* 1	1/223 (0.45%)	1/226 (0.44%)	0/224 (0.00%)
Atelectasis ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Choking ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Cough ^* 1	3/223 (1.35%)	2/226 (0.88%)	2/224 (0.89%)
Dysphonia ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Dyspnoea ^* 1	2/223 (0.90%)	0/226 (0.00%)	1/224 (0.45%)
Epistaxis ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Nasal congestion ^* 1	2/223 (0.90%)	2/226 (0.88%)	0/224 (0.00%)
Oropharyngeal pain ^* 1	1/223 (0.45%)	5/226 (2.21%)	2/224 (0.89%)
Rhinorrhoea ^* 1	1/223 (0.45%)	0/226 (0.00%)	2/224 (0.89%)
Sinus congestion ^* 1	2/223 (0.90%)	2/226 (0.88%)	3/224 (1.34%)
Wheezing ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Yawning ^* 1	3/223 (1.35%)	2/226 (0.88%)	4/224 (1.79%)
Skin and subcutaneous tissue disorders
Acne ^* 1	0/223 (0.00%)	1/226 (0.44%)	4/224 (1.79%)
Alopecia ^* 1	3/223 (1.35%)	0/226 (0.00%)	1/224 (0.45%)
Cold sweat ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Dermal cyst ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Dermatitis atopic ^* 1	1/223 (0.45%)	0/226 (0.00%)	1/224 (0.45%)
Dermatitis contact ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Dry skin ^* 1	1/223 (0.45%)	1/226 (0.44%)	0/224 (0.00%)
Ecchymosis ^* 1	1/223 (0.45%)	1/226 (0.44%)	2/224 (0.89%)
Hyperhidrosis ^* 1	11/223 (4.93%)	11/226 (4.87%)	12/224 (5.36%)
Hypoaesthesia facial ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Increased tendency to bruise ^* 1	0/223 (0.00%)	1/226 (0.44%)	1/224 (0.45%)
Ingrowing nail ^* 1	2/223 (0.90%)	0/226 (0.00%)	0/224 (0.00%)
Keloid scar ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
Night sweats ^* 1	0/223 (0.00%)	1/226 (0.44%)	3/224 (1.34%)
Pruritus ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Pruritus generalised ^* 1	1/223 (0.45%)	1/226 (0.44%)	0/224 (0.00%)
Rash ^* 1	0/223 (0.00%)	2/226 (0.88%)	1/224 (0.45%)
Rash generalised ^* 1	1/223 (0.45%)	0/226 (0.00%)	0/224 (0.00%)
Vascular disorders
Haematoma ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Hot flush ^* 1	6/223 (2.69%)	3/226 (1.33%)	4/224 (1.79%)
Hypertension ^* 1	4/223 (1.79%)	0/226 (0.00%)	2/224 (0.89%)
Orthostatic hypertension ^* 1	0/223 (0.00%)	0/226 (0.00%)	1/224 (0.45%)
Systolic hypertension ^* 1	0/223 (0.00%)	1/226 (0.44%)	0/224 (0.00%)
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA

Limitations and Caveats

[Not Specified]

More Information

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.

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

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Name/Title:	Pfizer ClinicalTrials.gov Call Center
Organization:	Pfizer, Inc.
Phone:	1-800-718-1021
EMail:	ClinicalTrials.gov_Inquiries@pfizer.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15.

McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13.

McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3). doi: 10.4088/PCC.14m01741. eCollection 2015.

Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.

Soares CN, Endicott J, Boucher M, Fayyad RS, Guico-Pabia CJ. Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder. CNS Spectr. 2014 Dec;19(6):519-27. doi: 10.1017/S1092852914000066. Epub 2014 Feb 26.

Liebowitz MR, Tourian KA, Hwang E, Mele L; Study 3362 Investigators. A double-blind, randomized, placebo-controlled study assessing the efficacy and tolerability of desvenlafaxine 10 and 50 mg/day in adult outpatients with major depressive disorder. BMC Psychiatry. 2013 Mar 22;13:94. doi: 10.1186/1471-244X-13-94.

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Responsible Party:	Director, Clinical Trial Disclosure Group, Wyeth
ClinicalTrials.gov Identifier:	NCT00863798
Other Study ID Numbers:	3151A1-3362 B2061005 3151A1-3362-US
First Submitted:	March 17, 2009
First Posted:	March 18, 2009
Results First Submitted:	March 8, 2011
Results First Posted:	May 6, 2011
Last Update Posted:	May 6, 2011

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