Clinical trial NCT00401726: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depressive Disorder, Major
Keywords: Major Depressive Disorder
Depression
Anxiety
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-11-20
Enrollment: 537
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Patients Responding "Very Satisfied" on Satisfaction With Depression Care Scale (SDCS)
timeFrame: 112 days
Secondary outcomes:
measure: Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks
timeFrame: Baseline and 112 days
measure: Patient Global Impression of Improvement (PGI-I) Score
timeFrame: 112 days
measure: Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks
timeFrame: Baseline and 112 days
measure: Number of Patients Compliant With Therapy
timeFrame: 112 days
measure: Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks
timeFrame: Baseline and 112 days
measure: Change in Sheehan Disability Scale Score From Baseline to 16 Weeks
timeFrame: Baseline and 112 days
measure: Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks
timeFrame: 112 days
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: San Jose
country: United States
state: California
city: Avon
country: United States
state: Connecticut
city: Cromwell
country: United States
state: Connecticut
city: Wilmington
country: United States
state: Delaware
city: Ocala
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: Stuart
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Cartersville
country: United States
state: Georgia
city: Rome
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Newburgh
country: United States
state: Indiana
city: Waterloo
country: United States
state: Iowa
city: Metairie
country: United States
state: Louisiana
city: Benzonia
country: United States
state: Michigan
city: Interlochen
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Chesterfield
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Charlotte
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Mason
country: United States
state: Ohio
city: Mogadore
country: United States
state: Ohio
city: Allentown
country: United States
state: Pennsylvania
city: Newtown
country: United States
state: Pennsylvania
city: Reading
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Anderson
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charleston
country: United States
state: West Virginia
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: