## Protocol Section
### Identification Module
**NCT ID:** NCT00445679

**Brief Title:** Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD

**Official Title:** A Multicenter, Randomized, Double-blind, Paroxetine-referenced, Parallel-group Study to Evaluate the Safety, Efficacy, and Tolerability of 3 Fixed Doses (50mg, 100mg, AND 200mg) of Desvenlafaxine Succinate Sustained-release Tablets in Adult Outpatients With Major Depressive Disorder

#### Organization Study ID Info
**ID:** 3151A1-336
#### Organization
**Class:** INDUSTRY
**Full Name:** Wyeth is now a wholly owned subsidiary of Pfizer
### Status Module
#### Completion Date
**Date:** 2009-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-11-03

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-10-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-02

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2013-11-03

**Type:** ESTIMATED

**Results First Submit Date:** 2010-02-26

**Results First Submit QC Date:** 2013-10-08

#### Start Date
**Date:** 2007-07

**Status Verified Date:** 2013-10

#### Study First Post Date
**Date:** 2007-03-09
**Type:** ESTIMATED
**Study First Submit Date:** 2007-03-06
**Study First Submit QC Date:** 2007-03-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Wyeth is now a wholly owned subsidiary of Pfizer

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.

**Detailed Description:** The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is to obtain additional information regarding the efficacy of DVS SR in subjects with MDD receiving daily doses of 50 mg, 100 mg, or 200 mg. Additional objectives include obtaining general and functional quality of life outcome data.

### Conditions Module

**Conditions:**

- Depressive Disorder, Major

**Keywords:**

- major depressive disorder

- MDD

- depression

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 807

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** DVS SR 50mg/day

**Intervention Names:**

- Drug: DVS SR

**Label:** A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** DVS SR 100mg/day

**Intervention Names:**

- Drug: DVS SR

**Label:** B

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** DVS SR 200mg/day

**Intervention Names:**

- Drug: DVS SR

**Label:** C

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Paroxetine 20mg/day

**Intervention Names:**

- Drug: Paroxetine

**Label:** D

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A

- B

- C

**Description:** Arm 1: 50mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper

**Name:** DVS SR

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- D

**Description:** 20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper

**Name:** Paroxetine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)

**Time Frame:** 8 weeks

#### Secondary Outcomes

**Description:** CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the subject's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).

**Measure:** Clinical Global Impressions Scale-Improvement (CGI-I) Scores

**Time Frame:** 8 weeks

**Description:** CGI-S is a global rating scale that measures the severity of a subject's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with subjects who have the same diagnosis (1= normal, not at all ill; 7= among the most extremely ill).

**Measure:** Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores

**Time Frame:** 8 weeks

**Description:** Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).

**Measure:** Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline

**Time Frame:** Baseline and 8 weeks

**Description:** The VAS-PI is a self-rated visual analog scale for the assessment of pain. Scores on the VAS-PI range from 0 (no pain) to 10 (worst possible pain). A decrease in VAS-PI overall scores indicates a subject's assessment of an improvement in pain.

**Measure:** Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline

**Time Frame:** 8 weeks

**Description:** HAM-D6: standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression.

**Measure:** Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline

**Time Frame:** 8 weeks

**Description:** Covi anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, 5 = Very much. Total score ranges from 3 to 15; higher score indicates more anxiety.

**Measure:** Covi Anxiety Scale Score Mean Change From Baseline

**Time Frame:** 8 weeks

### Eligibility Module

**Eligibility Criteria:** Primary Inclusion Criteria:

1. Outpatient men and women at least 18 years of age.
2. Have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent episode, without psychotic features.
3. Have a HAM D17 total score ≥20 at the screening and baseline (study day 1) visit.

Primary Exclusion Criteria:

1. Treatment with DVS SR at any time in the past.
2. Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.
3. Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beijing

**Country:** China

**Zip:** 100083

**Location 2:**

**City:** Beijing

**Country:** China

**Zip:** 100088

**Location 3:**

**City:** Guangdong Province

**Country:** China

**Zip:** 510370

**Location 4:**

**City:** Hunan Province

**Country:** China

**Zip:** 410011

**Location 5:**

**City:** Jiangsu Province

**Country:** China

**Zip:** 210029

**Location 6:**

**City:** Shanghai

**Country:** China

**Zip:** 200030

**Location 7:**

**City:** Shanghai

**Country:** China

**Zip:** 200065

**Location 8:**

**City:** Shanxi Province

**Country:** China

**Zip:** 710032

**Location 9:**

**City:** Sichuan Province

**Country:** China

**Zip:** 610041

**Location 10:**

**City:** Yunnan Province

**Country:** China

**Zip:** 650032

**Location 11:**

**City:** Zhejiang Province

**Country:** China

**Zip:** 310003

**Location 12:**

**City:** Andhra Pradesh

**Country:** India

**Zip:** 500 038

**Location 13:**

**City:** Andhra Pradesh

**Country:** India

**Zip:** 500034

**Location 14:**

**City:** Andhra Pradesh

**Country:** India

**Zip:** 517 507

**Location 15:**

**City:** Andhra Pradesh

**Country:** India

**Zip:** 530 002

**Location 16:**

**City:** Chandigarh

**Country:** India

**Zip:** 160012

**Location 17:**

**City:** Gujarat

**Country:** India

**Zip:** 380006

**Location 18:**

**City:** Gujarat

**Country:** India

**Zip:** 380013

**Location 19:**

**City:** Karnataka

**Country:** India

**Zip:** 575 001

**Location 20:**

**City:** Karnataka

**Country:** India

**Zip:** 575018

**Location 21:**

**City:** Maharashtra

**Country:** India

**Zip:** 400 012

**Location 22:**

**City:** Maharashtra

**Country:** India

**Zip:** 400 026

**Location 23:**

**City:** Maharashtra

**Country:** India

**Zip:** 411001

**Location 24:**

**City:** Mumbai Maharashtra

**Country:** India

**Zip:** H19400 022

**Location 25:**

**City:** New Delhi

**Country:** India

**Zip:** 110002

**Location 26:**

**City:** Punjab

**Country:** India

**Zip:** 141001

**Location 27:**

**City:** Uttar Pradesh

**Country:** India

**Zip:** 226003

**Location 28:**

**City:** Incheon

**Country:** Korea, Republic of

**Zip:** 400-711

**Location 29:**

**City:** Seoul

**Country:** Korea, Republic of

**Zip:** 110-744

**Location 30:**

**City:** Seoul

**Country:** Korea, Republic of

**Zip:** 135-710

**Location 31:**

**City:** Seoul

**Country:** Korea, Republic of

**Zip:** 135-720

**Location 32:**

**City:** Seoul

**Country:** Korea, Republic of

**Zip:** 137-701

**Location 33:**

**City:** Seoul

**Country:** Korea, Republic of

**Zip:** 138-736

**Location 34:**

**City:** Seoul

**Country:** Korea, Republic of

**Zip:** 140-757

**Location 35:**

**City:** Seoul

**Country:** Korea, Republic of

**Zip:** 150-719

**Location 36:**

**City:** Seoul

**Country:** Korea, Republic of

**Zip:** 158-710

**Location 37:**

**City:** Chang-Hua

**Country:** Taiwan

**Zip:** ROC 500

**Location 38:**

**City:** KaoHsiung

**Country:** Taiwan

**Zip:** ROC 80708

**Location 39:**

**City:** Taipei

**Country:** Taiwan

**Zip:** ROC 100

**Location 40:**

**City:** Taipei

**Country:** Taiwan

**Zip:** ROC 111

**Location 41:**

**City:** Taipei

**Country:** Taiwan

**Zip:** ROC 112

**Location 42:**

**City:** Taipei

**Country:** Taiwan

**Zip:** ROC 114

**Location 43:**

**City:** Taipei

**Country:** Taiwan

**Zip:** ROC 220

#### Overall Officials

**Official 1:**

**Affiliation:** Wyeth is now a wholly owned subsidiary of Pfizer

**Name:** Medical Monitor

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** For China: medinfo@wyeth.com

**Name:** Trial Manager

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depressive Disorder

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depressive Disorder

- ID: M7060

- Name: Depressive Disorder, Major

- Relevance: HIGH

- As Found: Depressive Disorder, Major

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003866

- Term: Depressive Disorder

- ID: D000003863

- Term: Depression

- ID: D000003865

- Term: Depressive Disorder, Major

### Intervention Browse Module - Ancestors

- ID: D000017367

- Term: Selective Serotonin Reuptake Inhibitors

- ID: D000014179

- Term: Neurotransmitter Uptake Inhibitors

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000018490

- Term: Serotonin Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018687

- Term: Antidepressive Agents, Second-Generation

- ID: D000000928

- Term: Antidepressive Agents

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000065690

- Term: Cytochrome P-450 CYP2D6 Inhibitors

- ID: D000065607

- Term: Cytochrome P-450 Enzyme Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19654

- Name: Paroxetine

- Relevance: HIGH

- As Found: Interleukin-

- ID: M437

- Name: Desvenlafaxine Succinate

- Relevance: LOW

- As Found: Unknown

- ID: M19649

- Name: Selective Serotonin Reuptake Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M15512

- Name: Serotonin

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4247

- Name: Antidepressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M30537

- Name: Cytochrome P-450 Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017374

- Term: Paroxetine

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** DVS SR 50

**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day

**ID:** EG000

**Other Num Affected:** 128

**Other Num at Risk:** 203

**Serious Number Affected:** 4

**Serious Number At Risk:** 203

**Title:** DVS SR 50

**Group ID:** EG001

**Title:** DVS SR 100

**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day

**ID:** EG001

**Other Num Affected:** 128

**Other Num at Risk:** 203

**Serious Number Affected:** 1

**Serious Number At Risk:** 203

**Title:** DVS SR 100

**Group ID:** EG002

**Title:** DVS SR 200

**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day

**ID:** EG002

**Other Num Affected:** 140

**Other Num at Risk:** 205

**Serious Number Affected:** 5

**Serious Number At Risk:** 205

**Title:** DVS SR 200

**Group ID:** EG003

**Title:** Paroxetine 20

**Description:** Paroxetine 20 mg/day

**ID:** EG003

**Other Num Affected:** 134

**Other Num at Risk:** 196

**Serious Number Affected:** 2

**Serious Number At Risk:** 196

**Title:** Paroxetine 20

**Frequency Threshold:** 5

#### Other Events

**Term:** Palpitations

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Constipation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Dry mouth

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Asthenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Nasopharyngitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Anorexia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Dizziness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Somnolence

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Insomnia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Dyspepsia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Sedation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Cholelithiasis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 203

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 203

**Group ID:** EG002

**Num At Risk:** 205

**Group ID:** EG003

**Num At Risk:** 196

**Term:** Pituitary tumor benign

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 203

**Group ID:** EG001

**Num At Risk:** 203

**Group ID:** EG002

**Num At Risk:** 205

**Group ID:** EG003

**Num At Risk:** 196

**Term:** Intentional overdose

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

##### Stats

**Group ID:** EG000

**Num At Risk:** 203

**Group ID:** EG001

**Num At Risk:** 203

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 205

**Group ID:** EG003

**Num At Risk:** 196

**Term:** Suicide attempt

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 203

**Group ID:** EG001

**Num At Risk:** 203

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 205

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 196

**Term:** Mania

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 203

**Group ID:** EG001

**Num At Risk:** 203

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 205

**Group ID:** EG003

**Num At Risk:** 196

**Term:** Suicidal behavior

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 203

**Group ID:** EG001

**Num At Risk:** 203

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 205

**Group ID:** EG003

**Num At Risk:** 196

**Term:** Suicidal ideation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 203

**Group ID:** EG001

**Num At Risk:** 203

**Group ID:** EG002

**Num At Risk:** 205

**Group ID:** EG003

**Num Affected:** 2

**Num At Risk:** 196

**Term:** Drug abuse

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 203

**Group ID:** EG001

**Num At Risk:** 203

**Group ID:** EG002

**Num At Risk:** 205

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 196

**Term:** Major Depressive Disorder worsening

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 203

**Group ID:** EG001

**Num At Risk:** 203

**Group ID:** EG002

**Num At Risk:** 205

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 196

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 203

**Group ID:** BG001

**Value:** 203

**Group ID:** BG002

**Value:** 205

**Group ID:** BG003

**Value:** 196

**Group ID:** BG004

**Value:** 807

**Units:** Participants

### Group

**ID:** BG000

**Title:** DVS SR 50

**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day

### Group

**ID:** BG001

**Title:** DVS SR 100

**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day

### Group

**ID:** BG002

**Title:** DVS SR 200

**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day

### Group

**ID:** BG003

**Title:** Paroxetine 20

**Description:** Paroxetine 20 mg/day

### Group

**ID:** BG004

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12.96

**Value:** 38.63

#### Measurement

**Group ID:** BG001

**Spread:** 13.22

**Value:** 39.26

#### Measurement

**Group ID:** BG002

**Spread:** 14.69

**Value:** 39.26

#### Measurement

**Group ID:** BG003

**Spread:** 13.22

**Value:** 38.27

#### Measurement

**Group ID:** BG004

**Spread:** 13.53

**Value:** 38.86

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 125

#### Measurement

**Group ID:** BG001

**Value:** 129

#### Measurement

**Group ID:** BG002

**Value:** 118

#### Measurement

**Group ID:** BG003

**Value:** 117

#### Measurement

**Group ID:** BG004

**Value:** 489

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 78

#### Measurement

**Group ID:** BG001

**Value:** 74

#### Measurement

**Group ID:** BG002

**Value:** 87

#### Measurement

**Group ID:** BG003

**Value:** 79

#### Measurement

**Group ID:** BG004

**Value:** 318

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** 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.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** clintrialresults@wyeth.com
**Organization:** Wyeth
**Title:** U. S. Contact Center
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -12.62
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 6.37
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Difference
**Parameter Value:** -3.13
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** True
#### Analysis
**CI Lower Limit:** -8.50
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 10.25
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Difference
**Parameter Value:** 0.88
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** True
#### Analysis
**CI Lower Limit:** -11.68
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 7.33
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Difference
**Parameter Value:** -2.17
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** True
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Final on-therapy population
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.714
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Final on-therapy population
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.653
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Final on-therapy population
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.881
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** False
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Final on-therapy population
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.450
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Final on-therapy population
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.452
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Final on-therapy population
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.850
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** False
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Anticipated Posting Date:** 2010-02
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 63
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 67
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 63
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 66
**Title:** 
#### Outcome Measure 2
**Anticipated Posting Date:** 2010-02
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 72
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 78
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 79
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 72
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 64
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 64
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 59
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 36
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 34
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 37
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 3
**Anticipated Posting Date:** 2010-02
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 42
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 49
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 47
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 49
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 46
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 34
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 30
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 38
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 4
**Anticipated Posting Date:** 2010-02
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -18.37
- **Spread:** 
- **Upper Limit:** -15.31
- **Value:** -16.84
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -19.37
- **Spread:** 
- **Upper Limit:** -16.31
- **Value:** -17.84
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -18.43
- **Spread:** 
- **Upper Limit:** -15.20
- **Value:** -16.81
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** -18.08
- **Spread:** 
- **Upper Limit:** -15.00
- **Value:** -16.54
**Title:** 
#### Outcome Measure 5
**Anticipated Posting Date:** 2010-02
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -15.10
- **Spread:** 
- **Upper Limit:** -8.27
- **Value:** -11.69
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -13.75
- **Spread:** 
- **Upper Limit:** -6.26
- **Value:** -10.00
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -12.75
- **Spread:** 
- **Upper Limit:** -5.45
- **Value:** -9.10
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** -12.40
- **Spread:** 
- **Upper Limit:** -6.63
- **Value:** -9.52
**Title:** 
#### Outcome Measure 6
**Anticipated Posting Date:** 2010-02
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -7.08
- **Spread:** 
- **Upper Limit:** -5.92
- **Value:** -6.50
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -7.06
- **Spread:** 
- **Upper Limit:** -5.95
- **Value:** -6.51
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -7.03
- **Spread:** 
- **Upper Limit:** -5.82
- **Value:** -6.42
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** -7.15
- **Spread:** 
- **Upper Limit:** -6.01
- **Value:** -6.58
**Title:** 
#### Outcome Measure 7
**Anticipated Posting Date:** 2010-02
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.47
- **Spread:** 
- **Upper Limit:** -0.99
- **Value:** -1.23
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.54
- **Spread:** 
- **Upper Limit:** -1.03
- **Value:** -1.28
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -1.44
- **Spread:** 
- **Upper Limit:** -0.89
- **Value:** -1.17
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** -1.49
- **Spread:** 
- **Upper Limit:** -1.00
- **Value:** -1.24
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**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.
**Parameter Type:** NUMBER
**Population Description:** The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation.
**Reporting Status:** POSTED
**Time Frame:** 8 weeks
**Title:** Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)
**Type:** PRIMARY
**Unit of Measure:** percentage of responders
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
**ID:** OG000
**Title:** DVS SR 50
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
**ID:** OG001
**Title:** DVS SR 100
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
**ID:** OG002
**Title:** DVS SR 200
##### Group
**Description:** Paroxetine 20 mg/day
**ID:** OG003
**Title:** Paroxetine 20
#### Outcome Measure 2
**Description:** CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the subject's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).
**Parameter Type:** NUMBER
**Population Description:** The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
**Reporting Status:** POSTED
**Time Frame:** 8 weeks
**Title:** Clinical Global Impressions Scale-Improvement (CGI-I) Scores
**Type:** SECONDARY
**Unit of Measure:** subjects
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
**ID:** OG000
**Title:** DVS SR 50
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
**ID:** OG001
**Title:** DVS SR 100
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
**ID:** OG002
**Title:** DVS SR 200
##### Group
**Description:** Paroxetine 20 mg/day
**ID:** OG003
**Title:** Paroxetine 20
#### Outcome Measure 3
**Description:** CGI-S is a global rating scale that measures the severity of a subject's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with subjects who have the same diagnosis (1= normal, not at all ill; 7= among the most extremely ill).
**Parameter Type:** NUMBER
**Population Description:** The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
**Reporting Status:** POSTED
**Time Frame:** 8 weeks
**Title:** Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores
**Type:** SECONDARY
**Unit of Measure:** subjects
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
**ID:** OG000
**Title:** DVS SR 50
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
**ID:** OG001
**Title:** DVS SR 100
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
**ID:** OG002
**Title:** DVS SR 200
##### Group
**Description:** Paroxetine 20 mg/day
**ID:** OG003
**Title:** Paroxetine 20
#### Outcome Measure 4
**Description:** Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 8 weeks
**Title:** Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
**ID:** OG000
**Title:** DVS SR 50
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
**ID:** OG001
**Title:** DVS SR 100
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
**ID:** OG002
**Title:** DVS SR 200
##### Group
**Description:** Paroxetine 20 mg/day
**ID:** OG003
**Title:** Paroxetine 20
#### Outcome Measure 5
**Description:** The VAS-PI is a self-rated visual analog scale for the assessment of pain. Scores on the VAS-PI range from 0 (no pain) to 10 (worst possible pain). A decrease in VAS-PI overall scores indicates a subject's assessment of an improvement in pain.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
**Reporting Status:** POSTED
**Time Frame:** 8 weeks
**Title:** Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline
**Type:** SECONDARY
**Unit of Measure:** scores on a scale
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
**ID:** OG000
**Title:** DVS SR 50
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
**ID:** OG001
**Title:** DVS SR 100
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
**ID:** OG002
**Title:** DVS SR 200
##### Group
**Description:** Paroxetine 20 mg/day
**ID:** OG003
**Title:** Paroxetine 20
#### Outcome Measure 6
**Description:** HAM-D6: standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
**Reporting Status:** POSTED
**Time Frame:** 8 weeks
**Title:** Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline
**Type:** SECONDARY
**Unit of Measure:** scores on a scale
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
**ID:** OG000
**Title:** DVS SR 50
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
**ID:** OG001
**Title:** DVS SR 100
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
**ID:** OG002
**Title:** DVS SR 200
##### Group
**Description:** Paroxetine 20 mg/day
**ID:** OG003
**Title:** Paroxetine 20
#### Outcome Measure 7
**Description:** Covi anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, 5 = Very much. Total score ranges from 3 to 15; higher score indicates more anxiety.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
**Reporting Status:** POSTED
**Time Frame:** 8 weeks
**Title:** Covi Anxiety Scale Score Mean Change From Baseline
**Type:** SECONDARY
**Unit of Measure:** scores on a scale
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
**ID:** OG000
**Title:** DVS SR 50
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
**ID:** OG001
**Title:** DVS SR 100
##### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
**ID:** OG002
**Title:** DVS SR 200
##### Group
**Description:** Paroxetine 20 mg/day
**ID:** OG003
**Title:** Paroxetine 20
### Participant Flow Module
#### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
**ID:** FG000
**Title:** DVS SR 50
#### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
**ID:** FG001
**Title:** DVS SR 100
#### Group
**Description:** Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
**ID:** FG002
**Title:** DVS SR 200
#### Group
**Description:** Paroxetine 20 mg/day
**ID:** FG003
**Title:** Paroxetine 20
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 22
###### Reason
**Group ID:** FG001
**Number of Subjects:** 12
###### Reason
**Group ID:** FG002
**Number of Subjects:** 30
###### Reason
**Group ID:** FG003
**Number of Subjects:** 19
##### Withdraw
**Type:** Failed to return
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
###### Reason
**Group ID:** FG003
**Number of Subjects:** 2
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 10
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
###### Reason
**Group ID:** FG002
**Number of Subjects:** 6
###### Reason
**Group ID:** FG003
**Number of Subjects:** 5
##### Withdraw
**Type:** Compliance
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 2
##### Withdraw
**Type:** Withdrawal of Informed Consent
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 14
###### Reason
**Group ID:** FG002
**Number of Subjects:** 20
###### Reason
**Group ID:** FG003
**Number of Subjects:** 18
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 203
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 203
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 205
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 196
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 155
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 157
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 139
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 149
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 48
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 46
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 66
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 47
**Pre-Assignment Details:** After a 4 to 21 day screening period, eligible subjects were treated for up to 8 weeks.
**Recruitment Details:** Subjects were recruited in China, India, South Korea and Taiwan from July 2007 to December 2008.
**Has Results:** True