Open-Label, Randomized Study Evaluating Treatment With Venlafaxine Extended-Release Plus Dialogues Time to Talk Program
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.
Depressive Disorder, Major
Drug: Venlafaxine ER
Behavioral: Dialogues Time to Talk Program
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Number of Patients Responding "Very Satisfied" on Satisfaction With Depression Care Scale (SDCS) [ Time Frame: 112 days ] [ Designated as safety issue: No ]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.
- Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks [ Time Frame: Baseline and 112 days ] [ Designated as safety issue: No ]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 [ Time Frame: 112 days ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 112 days ] [ Designated as safety issue: No ]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 [ Time Frame: 112 days ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 112 days ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 112 days ] [ Designated as safety issue: No ]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 [ Time Frame: 112 days ] [ Designated as safety issue: No ]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).
|Study Start Date:||June 2006|
|Study Completion Date:||October 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401726
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|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|