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

April 19, 2012 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

537

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
      • Birmingham, Alabama, United States, 35216
    • Arizona
      • Mesa, Arizona, United States, 85206
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
    • California
      • San Jose, California, United States, 95128
    • Connecticut
      • Avon, Connecticut, United States, 06001
      • Cromwell, Connecticut, United States, 06416
    • Delaware
      • Wilmington, Delaware, United States, 19805
    • Florida
      • Ocala, Florida, United States, 34471
      • Pinellas Park, Florida, United States, 33781
      • Stuart, Florida, United States, 34996
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Cartersville, Georgia, United States, 30120
      • Rome, Georgia, United States, 30165
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
    • Indiana
      • Newburgh, Indiana, United States, 47630
    • Iowa
      • Waterloo, Iowa, United States, 50702
    • Louisiana
      • Metairie, Louisiana, United States, 70006
    • Michigan
      • Benzonia, Michigan, United States, 49616
      • Interlochen, Michigan, United States, 49643
      • Kalamazoo, Michigan, United States, 49009
    • Missouri
      • Chesterfield, Missouri, United States, 63017
    • Nebraska
      • Omaha, Nebraska, United States, 68134
    • Nevada
      • Las Vegas, Nevada, United States, 89146
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
      • Charlotte, North Carolina, United States, 28262
    • Ohio
      • Cincinnati, Ohio, United States, 45236
      • Columbus, Ohio, United States, 43212
      • Kettering, Ohio, United States, 45429
      • Mason, Ohio, United States, 45040
      • Mogadore, Ohio, United States, 44260
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
      • Newtown, Pennsylvania, United States, 18940
      • Reading, Pennsylvania, United States, 19606
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
    • South Carolina
      • Anderson, South Carolina, United States, 29621
      • Greer, South Carolina, United States, 29651
    • Tennessee
      • Bristol, Tennessee, United States, 37620
    • Texas
      • Dallas, Texas, United States, 75235
      • Fort Worth, Texas, United States, 76135
      • Plano, Texas, United States, 75093
      • San Antonio, Texas, United States, 78229
    • Utah
      • Salt Lake City, Utah, United States, 84107
    • West Virginia
      • Charleston, West Virginia, United States, 25301

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Responding "Very Satisfied" on Satisfaction With Depression Care Scale (SDCS)
Time Frame: 112 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks
Time Frame: Baseline and 112 days
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
Patient Global Impression of Improvement (PGI-I) Score
Time Frame: 112 days
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
Time Frame: Baseline and 112 days
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
Time Frame: 112 days
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
Time Frame: Baseline and 112 days
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
Time Frame: Baseline and 112 days
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
Time Frame: 112 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

November 17, 2006

First Submitted That Met QC Criteria

November 17, 2006

First Posted (Estimate)

November 20, 2006

Study Record Updates

Last Update Posted (Estimate)

April 23, 2012

Last Update Submitted That Met QC Criteria

April 19, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0600B1-416

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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