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

Wyeth

Status and phase: Completed; Phase 4

Conditions: Depressive Disorder, Major

Treatments: Drug: Venlafaxine ER; Behavioral: Dialogues Time to Talk Program

Study type: Interventional

Funder types: Industry

Identifiers

NCT00401726

0600B1-416

Details and patient eligibility

About

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.

Enrollment: 537 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)