Effectiveness Study of Vilazodone to Treat Depression and to Discover Genetic Markers Associated With Response
NCT ID: NCT00285376
Last Updated: 2008-02-21
Study Results
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Basic Information
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COMPLETED
PHASE3
410 participants
INTERVENTIONAL
2006-02-28
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
vilazodone
vilazodone
titration to 40mg tablets qd for 8 weeks
2
vilazodone
titration to 40mg tablets qd for 8 weeks
Interventions
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vilazodone
titration to 40mg tablets qd for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A diagnosis of MDD, single episode or recurrent, according to DSM-IV-TR (296.2/296.3) with a current Major Depressive Episode of less than two year's duration with a minimum duration of at least 4 weeks.
* HAM-D score ≥ 22.
* HAM-D item 1 (depressed mood) score ≥ 2.
* Patients must be able to provide written informed consent to participate before beginning any trial related activities.
* Patients must be able to speak, read and understand English and possess the ability to respond to questions and follow simple instructions.
Exclusion Criteria
* A history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes).
* DSM-IV-TR criteria for substance abuse (alcohol or drugs) within 3 months prior to Screening Visit or substance dependence within 6 months prior to the Screening Visit.
* Criteria for any of the following DSM-IV-TR MDD Specifiers: \[a\] With Catatonic Features; \[b\] With Postpartum Onset; \[c\] With Seasonal Pattern.
18 Years
65 Years
ALL
No
Sponsors
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Genaissance Pharmaceuticals
INDUSTRY
Responsible Party
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Genaissance Pharmaceuticals
Principal Investigators
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Carol Reed, M.D.
Role: STUDY_DIRECTOR
Genaissance Pharmaceuticals
Locations
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Pharmacology Research Institute
Los Alamitos, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
Pharmacology Research Institute
Northridge, California, United States
Pharmacology Research Institute
Riverside, California, United States
Atlanta Institute of Medicine & Research
Atlanta, Georgia, United States
Atlanta Institute of Medicine & Research
Marietta, Georgia, United States
Summit Research Network (Michigan), Inc.
Farmington Hills, Michigan, United States
Summit Research Network (Michigan), Inc.
Flint, Michigan, United States
Social Psychiatry Research Institute
Brooklyn, New York, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States
University of Pennsylvania Department of Psychiatry Mood and Anxiety Disorders Section
Philadelphia, Pennsylvania, United States
Southeast Health Consultants, LLC
Charleston, South Carolina, United States
University of Utah health Services Center Dept. of Psychiatry Mood and Anxiety Disorders
Salt Lake City, Utah, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, United States
Countries
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References
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Kornstein S, Chang CT, Gommoll CP, Edwards J. Vilazodone efficacy in subgroups of patients with major depressive disorder: a post-hoc analysis of four randomized, double-blind, placebo-controlled trials. Int Clin Psychopharmacol. 2018 Jul;33(4):217-223. doi: 10.1097/YIC.0000000000000217.
Culpepper L, Mathews M, Ghori R, Edwards J. Clinical relevance of vilazodone treatment in patients with major depressive disorder: categorical improvement in symptoms. Prim Care Companion CNS Disord. 2014;16(1):PCC.13m01571. doi: 10.4088/PCC.13m01571. Epub 2014 Jan 30.
Jain R, Chen D, Edwards J, Mathews M. Early and sustained improvement with vilazodone in adult patients with major depressive disorder: post hoc analyses of two phase III trials. Curr Med Res Opin. 2014 Feb;30(2):263-70. doi: 10.1185/03007995.2013.855188. Epub 2013 Oct 31.
Clayton AH, Kennedy SH, Edwards JB, Gallipoli S, Reed CR. The effect of vilazodone on sexual function during the treatment of major depressive disorder. J Sex Med. 2013 Oct;10(10):2465-76. doi: 10.1111/jsm.12004. Epub 2012 Dec 6.
Reed CR, Kajdasz DK, Whalen H, Athanasiou MC, Gallipoli S, Thase ME. The efficacy profile of vilazodone, a novel antidepressant for the treatment of major depressive disorder. Curr Med Res Opin. 2012 Jan;28(1):27-39. doi: 10.1185/03007995.2011.628303. Epub 2011 Nov 23.
Rickels K, Athanasiou M, Robinson DS, Gibertini M, Whalen H, Reed CR. Evidence for efficacy and tolerability of vilazodone in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 Mar;70(3):326-33. doi: 10.4088/jcp.08m04637. Epub 2009 Mar 10.
Other Identifiers
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GNSC-04-DP-02
Identifier Type: -
Identifier Source: org_study_id
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