Open-Label, Randomized Study Evaluating Treatment With Venlafaxine Extended-Release Plus Dialogues Time to Talk Program
|ClinicalTrials.gov Identifier: NCT00401726|
Recruitment Status : Completed
First Posted : November 20, 2006
Results First Posted : June 29, 2010
Last Update Posted : April 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder, Major||Drug: Venlafaxine ER Behavioral: Dialogues Time to Talk Program||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||537 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2006|
|Study Completion Date :||October 2007|
- Number of Patients Responding "Very Satisfied" on Satisfaction With Depression Care Scale (SDCS) [ Time Frame: 112 days ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401726
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|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|