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Open-Label, Randomized Study Evaluating Treatment With Venlafaxine Extended-Release Plus Dialogues Time to Talk Program

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depressive Disorder, Major

Intervention: Venlafaxine ER (Drug); Dialogues Time to Talk Program (Behavioral)

Phase: Phase 4

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Patients Responding "Very Satisfied" on Satisfaction With Depression Care Scale (SDCS)

Secondary outcome:

Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks

Patient Global Impression of Improvement (PGI-I) Score

Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks

Number of Patients Compliant With Therapy

Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks

Change in Sheehan Disability Scale Score From Baseline to 16 Weeks

Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- 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

Exclusion Criteria:

- History or presence of bipolar disorder

- Current treatment with venlafaxine

Locations and Contacts

Birmingham, Alabama 35216, United States

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

Additional Information

Starting date: June 2006
Last updated: April 19, 2012

Page last updated: August 23, 2015

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