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

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Venlafaxine ER
Dialogues Time to Talk Program
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Major Depressive Disorder, Depression, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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".
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.
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.
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).

Full Information

First Posted
November 17, 2006
Last Updated
April 19, 2012
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00401726
Brief Title
Open-Label, Randomized Study Evaluating Treatment With Venlafaxine Extended-Release Plus Dialogues Time to Talk Program
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 Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Major Depressive Disorder, Depression, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
537 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Venlafaxine ER
Intervention Type
Behavioral
Intervention Name(s)
Dialogues Time to Talk Program
Primary Outcome Measure Information:
Title
Number of Patients Responding "Very Satisfied" on Satisfaction With Depression Care Scale (SDCS)
Description
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.
Time Frame
112 days
Secondary Outcome Measure Information:
Title
Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks
Description
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.
Time Frame
Baseline and 112 days
Title
Patient Global Impression of Improvement (PGI-I) Score
Description
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.
Time Frame
112 days
Title
Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks
Description
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.
Time Frame
Baseline and 112 days
Title
Number of Patients Compliant With Therapy
Description
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".
Time Frame
112 days
Title
Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks
Description
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.
Time Frame
Baseline and 112 days
Title
Change in Sheehan Disability Scale Score From Baseline to 16 Weeks
Description
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.
Time Frame
Baseline and 112 days
Title
Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks
Description
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).
Time Frame
112 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
City
Avon
State/Province
Connecticut
ZIP/Postal Code
06001
Country
United States
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19805
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
City
Stuart
State/Province
Florida
ZIP/Postal Code
34996
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Cartersville
State/Province
Georgia
ZIP/Postal Code
30120
Country
United States
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50702
Country
United States
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
City
Benzonia
State/Province
Michigan
ZIP/Postal Code
49616
Country
United States
City
Interlochen
State/Province
Michigan
ZIP/Postal Code
49643
Country
United States
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
City
Newtown
State/Province
Pennsylvania
ZIP/Postal Code
18940
Country
United States
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19606
Country
United States
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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