Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DVS-233 SR
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria: Outpatients Sexually active women participating in the study must use a medically acceptable form of contraception Subjects must have a primary diagnosis of major depressive disorder of 4 on Clinical Global Impressions-Severity scale (CGI-S) Exclusion Criteria: Treatment with DVS-233 SR at any time in the past Treatment with venlafaxine (immediate release [IR] or extended release [ER]) within 90 days of study day 1 Known hypersensitivity to venlafaxine (IR or ER)
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00073762
First Posted
December 4, 2003
Last Updated
August 18, 2009
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00073762
Brief Title
Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Two Fixed Doses (200 Mg, Or 400 Mg) Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
Primary Objective: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.
Secondary Objective: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general wellbeing, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D17] less than or equal to 7) versus those subjects receiving placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
375 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
DVS-233 SR
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Outpatients
Sexually active women participating in the study must use a medically acceptable form of contraception
Subjects must have a primary diagnosis of major depressive disorder of 4 on Clinical Global Impressions-Severity scale (CGI-S)
Exclusion Criteria:
Treatment with DVS-233 SR at any time in the past
Treatment with venlafaxine (immediate release [IR] or extended release [ER]) within 90 days of study day 1
Known hypersensitivity to venlafaxine (IR or ER)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor, MD
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
25758058
Citation
Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.
Results Reference
derived
Learn more about this trial
Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder
We'll reach out to this number within 24 hrs