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This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | DVS SR 50mg/day |
|
| B | Experimental | DVS SR 100mg/day |
|
| C | Experimental | DVS SR 200mg/day |
|
| D | Active Comparator | Paroxetine 20mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DVS SR | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17) | 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impressions Scale-Improvement (CGI-I) Scores | 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). | 8 weeks |
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Primary Inclusion Criteria:
Primary Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For China: medinfo@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | 100083 | China | ||||
After a 4 to 21 day screening period, eligible subjects were treated for up to 8 weeks.
Subjects were recruited in China, India, South Korea and Taiwan from July 2007 to December 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | DVS SR 50 | Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day |
| FG001 | DVS SR 100 | Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Paroxetine | Drug | 20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper |
|
| Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores |
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). |
| 8 weeks |
| Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline | 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). | Baseline and 8 weeks |
| Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline | 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. | 8 weeks |
| Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline | 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. | 8 weeks |
| Covi Anxiety Scale Score Mean Change From Baseline | 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. | 8 weeks |
| Beijing |
| 100088 |
| China |
| Guangdong Province | 510370 | China |
| Hunan Province | 410011 | China |
| Jiangsu Province | 210029 | China |
| Shanghai | 200030 | China |
| Shanghai | 200065 | China |
| Shanxi Province | 710032 | China |
| Sichuan Province | 610041 | China |
| Yunnan Province | 650032 | China |
| Zhejiang Province | 310003 | China |
| Andhra Pradesh | 500 038 | India |
| Andhra Pradesh | 500034 | India |
| Andhra Pradesh | 517 507 | India |
| Andhra Pradesh | 530 002 | India |
| Chandigarh | 160012 | India |
| Gujarat | 380006 | India |
| Gujarat | 380013 | India |
| Karnataka | 575 001 | India |
| Karnataka | 575018 | India |
| Maharashtra | 400 012 | India |
| Maharashtra | 400 026 | India |
| Maharashtra | 411001 | India |
| Mumbai Maharashtra | H19400 022 | India |
| New Delhi | 110002 | India |
| Punjab | 141001 | India |
| Uttar Pradesh | 226003 | India |
| Incheon | 400-711 | South Korea |
| Seoul | 110-744 | South Korea |
| Seoul | 135-710 | South Korea |
| Seoul | 135-720 | South Korea |
| Seoul | 137-701 | South Korea |
| Seoul | 138-736 | South Korea |
| Seoul | 140-757 | South Korea |
| Seoul | 150-719 | South Korea |
| Seoul | 158-710 | South Korea |
| Chang-hua | ROC 500 | Taiwan |
| Kaohsiung City | ROC 80708 | Taiwan |
| Taipei | ROC 100 | Taiwan |
| Taipei | ROC 111 | Taiwan |
| Taipei | ROC 112 | Taiwan |
| Taipei | ROC 114 | Taiwan |
| Taipei | ROC 220 | Taiwan |
| FG002 | DVS SR 200 | Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day |
| FG003 | Paroxetine 20 | Paroxetine 20 mg/day |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DVS SR 50 | Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day |
| BG001 | DVS SR 100 | Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day |
| BG002 | DVS SR 200 | Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day |
| BG003 | Paroxetine 20 | Paroxetine 20 mg/day |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17) | 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. | 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. | Posted | Feb 2010 | Number | percentage of responders | 8 weeks |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | 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). | 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. | Posted | Feb 2010 | Number | subjects | 8 weeks |
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| Secondary | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | 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). | 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. | Posted | Feb 2010 | Number | subjects | 8 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline | 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). | 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. | Posted | Feb 2010 | Mean | 95% Confidence Interval | units on a scale | Baseline and 8 weeks |
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| Secondary | Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline | 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. | 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. | Posted | Feb 2010 | Mean | 95% Confidence Interval | scores on a scale | 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline | 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. | 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. | Posted | Feb 2010 | Mean | 95% Confidence Interval | scores on a scale | 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Covi Anxiety Scale Score Mean Change From Baseline | 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. | 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. | Posted | Feb 2010 | Mean | 95% Confidence Interval | scores on a scale | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DVS SR 50 | Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day | 4 | 203 | 128 | 203 | ||
| EG001 | DVS SR 100 | Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day | 1 | 203 | 128 | 203 | ||
| EG002 | DVS SR 200 | Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day | 5 | 205 | 140 | 205 | ||
| EG003 | Paroxetine 20 | Paroxetine 20 mg/day | 2 | 196 | 134 | 196 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pituitary tumor benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Intentional overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Suicide attempt | Psychiatric disorders | Non-systematic Assessment |
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| Mania | Psychiatric disorders | Non-systematic Assessment |
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| Suicidal behavior | Psychiatric disorders | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
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| Drug abuse | Psychiatric disorders | Non-systematic Assessment |
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| Major Depressive Disorder worsening | Psychiatric disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Asthenia | General disorders | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Sedation | Nervous system disorders | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| U. S. Contact Center | Wyeth | clintrialresults@wyeth.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|
| Difference |
| 0.88 |
| 2-Sided |
| 95 |
| -8.50 |
| 10.25 |
| Yes |
| Non-Inferiority or Equivalence |
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. |
| Difference | -2.17 | 2-Sided | 95 | -11.68 | 7.33 | Yes | Non-Inferiority or Equivalence | 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. |
Paroxetine 20 mg/day
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Paroxetine 20 mg/day |
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Paroxetine 20 mg/day |
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Paroxetine 20 mg/day
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| OG003 |
| Paroxetine 20 |
Paroxetine 20 mg/day |
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Paroxetine 20 mg/day |
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