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The purpose of this study is to evaluate the effect of the Dialogues Time to Talk program in subjects treated with Venlafaxine Extended Release (ER). Dialogues Time to Talk Program is a patient management program, which aims to help patients achieve successful outcomes by reinforcing physician treatment efforts, providing feedback to treating physicians, and encouraging better physician-patient communications.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venlafaxine ER | Drug | |||
| Dialogues Time to Talk Program | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Responding "Very Satisfied" on Satisfaction With Depression Care Scale (SDCS) | Patient satisfaction with depression care treatment was evaluated by patient self-assessment using the SDCS, a 10-point visual analog scale (0=not at all satisfied, 10=extremely satisfied). "Very satisfied" was defined as a score of greater than or equal to 8. | 112 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2 or 4 scale (0 = none/absent and 4 = most severe) with a maximum total score of 50. Change = 16 week adjusted mean HAM-D17 score minus baseline. | Baseline and 112 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35216 | United States | |||
Subjects were enrolled according to the inclusion / exclusion criteria. There was not a screening period.
Subjects were recruited in the United States from June 2006 to March 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Venlafaxine Extended Release (ER) | 75-225 mg per day |
| FG001 | Venlafaxine Extended Release (ER) Plus Dialogues | Venlafaxine ER 75-225 mg per day plus "Dialogues Time to Talk" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Patient Global Impression of Improvement (PGI-I) Score | PGI-I is a global rating scale that measures disease improvement. Using a 7-point scale (1=very much improved, 7=very much worse), the patients rate how much their illness has improved or worsened relative to their baseline status. | 112 days |
| Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks | WHO 5-item Well Being Index (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). Change = 16 week adjusted mean WHO-5 score minus baseline. | Baseline and 112 days |
| Number of Patients Compliant With Therapy | Patient compliance with therapy was assessed using a Medical Adherence Questionnaire (MAQ). MAQ consisted of 5 levels of compliance with taking medicine: Never miss, Sometimes miss, Miss half of the time, Miss most of the time, Always miss. Compliance with therapy was defined as a response of "Never miss" or "Sometimes miss". | 112 days |
| Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks | IDS-SR is a patient self-administered tool used to measure the severity of depressive symptoms. Each symptom is assessed on a scale of 0 to 3 (0=absence of symptom to 3=sever symptom) for a total maximum score of 84. | Baseline and 112 days |
| Change in Sheehan Disability Scale Score From Baseline to 16 Weeks | The Sheehan Disability Scale is a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life and Family Life/Home Responsibilities. The patient rates the extent to which each of these domains are impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired and 10=extremely impaired) for a total maximum score of 30. | Baseline and 112 days |
| Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1=very much improved, 7=very much worse). | 112 days |
| Birmingham |
| Alabama |
| 35235 |
| United States |
| Mesa | Arizona | 85206 | United States |
| Little Rock | Arkansas | 72211 | United States |
| San Jose | California | 95128 | United States |
| Avon | Connecticut | 06001 | United States |
| Cromwell | Connecticut | 06416 | United States |
| Wilmington | Delaware | 19805 | United States |
| Ocala | Florida | 34471 | United States |
| Pinellas Park | Florida | 33781 | United States |
| Stuart | Florida | 34996 | United States |
| Atlanta | Georgia | 30308 | United States |
| Cartersville | Georgia | 30120 | United States |
| Rome | Georgia | 30165 | United States |
| Idaho Falls | Idaho | 83404 | United States |
| Newburgh | Indiana | 47630 | United States |
| Waterloo | Iowa | 50702 | United States |
| Metairie | Louisiana | 70006 | United States |
| Benzonia | Michigan | 49616 | United States |
| Interlochen | Michigan | 49643 | United States |
| Kalamazoo | Michigan | 49009 | United States |
| Chesterfield | Missouri | 63017 | United States |
| Omaha | Nebraska | 68134 | United States |
| Las Vegas | Nevada | 89146 | United States |
| Charlotte | North Carolina | 28209 | United States |
| Charlotte | North Carolina | 28262 | United States |
| Cincinnati | Ohio | 45236 | United States |
| Columbus | Ohio | 43212 | United States |
| Kettering | Ohio | 45429 | United States |
| Mason | Ohio | 45040 | United States |
| Mogadore | Ohio | 44260 | United States |
| Allentown | Pennsylvania | 18104 | United States |
| Newtown | Pennsylvania | 18940 | United States |
| Reading | Pennsylvania | 19606 | United States |
| Warwick | Rhode Island | 02886 | United States |
| Anderson | South Carolina | 29621 | United States |
| Greer | South Carolina | 29651 | United States |
| Bristol | Tennessee | 37620 | United States |
| Dallas | Texas | 75235 | United States |
| Fort Worth | Texas | 76135 | United States |
| Plano | Texas | 75093 | United States |
| San Antonio | Texas | 78229 | United States |
| Salt Lake City | Utah | 84107 | United States |
| Charleston | West Virginia | 25301 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Venlafaxine Extended Release (ER) | 75-225 mg per day |
| BG001 | Venlafaxine Extended Release (ER) Plus Dialogues | Venlafaxine ER 75-225 mg per day plus "Dialogues Time to Talk" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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 | Number of Patients Responding "Very Satisfied" on Satisfaction With Depression Care Scale (SDCS) | Patient satisfaction with depression care treatment was evaluated by patient self-assessment using the SDCS, a 10-point visual analog scale (0=not at all satisfied, 10=extremely satisfied). "Very satisfied" was defined as a score of greater than or equal to 8. | The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward. | Posted | Mar 2009 | Number | participants | 112 days |
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| Secondary | Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2 or 4 scale (0 = none/absent and 4 = most severe) with a maximum total score of 50. Change = 16 week adjusted mean HAM-D17 score minus baseline. | The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward. | Posted | Mar 2009 | Mean | Standard Error | units on scale | Baseline and 112 days |
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| Secondary | Patient Global Impression of Improvement (PGI-I) Score | PGI-I is a global rating scale that measures disease improvement. Using a 7-point scale (1=very much improved, 7=very much worse), the patients rate how much their illness has improved or worsened relative to their baseline status. | The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward. | Posted | Mar 2009 | Mean | Standard Error | units on scale | 112 days |
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| Secondary | Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks | WHO 5-item Well Being Index (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). Change = 16 week adjusted mean WHO-5 score minus baseline. | The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward. | Posted | Mar 2009 | Mean | Standard Error | units on scale | Baseline and 112 days |
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| Secondary | Number of Patients Compliant With Therapy | Patient compliance with therapy was assessed using a Medical Adherence Questionnaire (MAQ). MAQ consisted of 5 levels of compliance with taking medicine: Never miss, Sometimes miss, Miss half of the time, Miss most of the time, Always miss. Compliance with therapy was defined as a response of "Never miss" or "Sometimes miss". | The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward. | Posted | Mar 2009 | Number | participants | 112 days |
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| Secondary | Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks | IDS-SR is a patient self-administered tool used to measure the severity of depressive symptoms. Each symptom is assessed on a scale of 0 to 3 (0=absence of symptom to 3=sever symptom) for a total maximum score of 84. | The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward. | Posted | Mar 2009 | Mean | Standard Error | units on scale | Baseline and 112 days |
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| Secondary | Change in Sheehan Disability Scale Score From Baseline to 16 Weeks | The Sheehan Disability Scale is a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life and Family Life/Home Responsibilities. The patient rates the extent to which each of these domains are impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired and 10=extremely impaired) for a total maximum score of 30. | The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward. | Posted | Mar 2009 | Mean | Standard Error | units on scale | Baseline and 112 days |
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| Secondary | Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks | CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1=very much improved, 7=very much worse). | The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward. Data not available for one participant. | Posted | Mar 2009 | Number | patients | 112 days |
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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 | Venlafaxine Extended Release (ER) | 75-225 mg per day | 10 | 269 | 209 | 269 | ||
| EG001 | Venlafaxine Extended Release (ER) Plus Dialogues | Venlafaxine ER 75-225 mg per day plus "Dialogues Time to Talk" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication. | 18 | 268 | 214 | 268 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Angina Pectoris | Cardiac disorders | Non-systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Cerebrovascular Accident | Vascular disorders | Non-systematic Assessment |
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| Chest pain | Cardiac disorders | Non-systematic Assessment |
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| Cholecystits | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Cholelithiasis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Coronary Artery Disorder | Cardiac disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Drug Abuse | General disorders | Non-systematic Assessment |
| ||
| Hernia | General disorders | Non-systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Non-systematic Assessment |
| ||
| Intracranial Hemorrhage | Vascular disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Neurosis | Psychiatric disorders | Non-systematic Assessment |
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| Non-specific Drug Reaction | General disorders | Non-systematic Assessment |
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| Overdose | General disorders | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Self-injurious Ideation | General disorders | Non-systematic Assessment |
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| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
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| Suicide | Psychiatric disorders | Non-systematic Assessment |
| ||
| Suicide Attempt | Psychiatric disorders | Non-systematic Assessment |
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| Supraventricular Tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Thinking Abnormal | Psychiatric disorders | Non-systematic Assessment |
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| Unintended Pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | Non-systematic Assessment |
| ||
| Headache | General disorders | Non-systematic Assessment |
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| Infection | General disorders | Non-systematic Assessment |
| ||
| Cardiovascular general | Cardiac disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Metabolic and nutritional general | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Musculoskeletal general | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Insomnia | Nervous system disorders | Non-systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Non-systematic Assessment |
| ||
| Respiratory general | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Skin and appendages general | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Special senses general | Eye disorders | Non-systematic Assessment |
| ||
| Urogenital general | Renal and urinary disorders | Non-systematic Assessment |
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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 |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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