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

NCT ID: NCT00401726

Last Updated: 2012-04-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

537 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Depressive Disorder, Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Venlafaxine ER

Intervention Type DRUG

Dialogues Time to Talk Program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Birmingham, Alabama, United States

Site Status

Birmingham, Alabama, United States

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Mesa, Arizona, United States

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Little Rock, Arkansas, United States

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San Jose, California, United States

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Avon, Connecticut, United States

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Cromwell, Connecticut, United States

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Wilmington, Delaware, United States

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Ocala, Florida, United States

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Pinellas Park, Florida, United States

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Stuart, Florida, United States

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Atlanta, Georgia, United States

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Cartersville, Georgia, United States

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Rome, Georgia, United States

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Idaho Falls, Idaho, United States

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Newburgh, Indiana, United States

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Waterloo, Iowa, United States

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Metairie, Louisiana, United States

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Benzonia, Michigan, United States

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Interlochen, Michigan, United States

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Kalamazoo, Michigan, United States

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Chesterfield, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Kettering, Ohio, United States

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Mason, Ohio, United States

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Mogadore, Ohio, United States

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Allentown, Pennsylvania, United States

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Newtown, Pennsylvania, United States

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Reading, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Anderson, South Carolina, United States

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Greer, South Carolina, United States

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Bristol, Tennessee, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Charleston, West Virginia, United States

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Countries

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United States

Other Identifiers

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0600B1-416

Identifier Type: -

Identifier Source: org_study_id

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