Open-Label, Randomized Study Evaluating Treatment With Venlafaxine Extended-Release Plus Dialogues Time to Talk Program
Patient Outcomes With Education, Drug Therapy, and Support (POETS): A Multicenter, Open-label, Randomized Study to Evaluate Depressed Subjects Treated With Venlafaxine Extended-release vs. Venlafaxine Extended-release Plus the Dialogues Time to Talk Program in a Primary Care Setting
1 other identifier
interventional
537
1 country
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2006
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 17, 2006
CompletedFirst Posted
Study publicly available on registry
November 20, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedResults Posted
Study results publicly available
June 29, 2010
CompletedApril 23, 2012
April 1, 2012
November 17, 2006
March 31, 2009
April 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (7)
Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks
Baseline and 112 days
Patient Global Impression of Improvement (PGI-I) Score
112 days
Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks
Baseline and 112 days
Number of Patients Compliant With Therapy
112 days
Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks
Baseline and 112 days
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Currently experiencing a major depressive episode, which requires the initiation of antidepressant drug treatment or a change in current antidepressant drug treatment
- At least 18 years of age
You may not qualify if:
- History or presence of bipolar disorder
- Current treatment with venlafaxine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Unknown Facility
Birmingham, Alabama, 35216, United States
Unknown Facility
Birmingham, Alabama, 35235, United States
Unknown Facility
Mesa, Arizona, 85206, United States
Unknown Facility
Little Rock, Arkansas, 72211, United States
Unknown Facility
San Jose, California, 95128, United States
Unknown Facility
Avon, Connecticut, 06001, United States
Unknown Facility
Cromwell, Connecticut, 06416, United States
Unknown Facility
Wilmington, Delaware, 19805, United States
Unknown Facility
Ocala, Florida, 34471, United States
Unknown Facility
Pinellas Park, Florida, 33781, United States
Unknown Facility
Stuart, Florida, 34996, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Cartersville, Georgia, 30120, United States
Unknown Facility
Rome, Georgia, 30165, United States
Unknown Facility
Idaho Falls, Idaho, 83404, United States
Unknown Facility
Newburgh, Indiana, 47630, United States
Unknown Facility
Waterloo, Iowa, 50702, United States
Unknown Facility
Metairie, Louisiana, 70006, United States
Unknown Facility
Benzonia, Michigan, 49616, United States
Unknown Facility
Interlochen, Michigan, 49643, United States
Unknown Facility
Kalamazoo, Michigan, 49009, United States
Unknown Facility
Chesterfield, Missouri, 63017, United States
Unknown Facility
Omaha, Nebraska, 68134, United States
Unknown Facility
Las Vegas, Nevada, 89146, United States
Unknown Facility
Charlotte, North Carolina, 28209, United States
Unknown Facility
Charlotte, North Carolina, 28262, United States
Unknown Facility
Cincinnati, Ohio, 45236, United States
Unknown Facility
Columbus, Ohio, 43212, United States
Unknown Facility
Kettering, Ohio, 45429, United States
Unknown Facility
Mason, Ohio, 45040, United States
Unknown Facility
Mogadore, Ohio, 44260, United States
Unknown Facility
Allentown, Pennsylvania, 18104, United States
Unknown Facility
Newtown, Pennsylvania, 18940, United States
Unknown Facility
Reading, Pennsylvania, 19606, United States
Unknown Facility
Warwick, Rhode Island, 02886, United States
Unknown Facility
Anderson, South Carolina, 29621, United States
Unknown Facility
Greer, South Carolina, 29651, United States
Unknown Facility
Bristol, Tennessee, 37620, United States
Unknown Facility
Dallas, Texas, 75235, United States
Unknown Facility
Fort Worth, Texas, 76135, United States
Unknown Facility
Plano, Texas, 75093, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Salt Lake City, Utah, 84107, United States
Unknown Facility
Charleston, West Virginia, 25301, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- U. S. Contact Center
- Organization
- Wyeth
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 17, 2006
First Posted
November 20, 2006
Study Start
June 1, 2006
Study Completion
October 1, 2007
Last Updated
April 23, 2012
Results First Posted
June 29, 2010
Record last verified: 2012-04