Safety and Efficacy of Vilazodone in Major Depressive Disorder
NCT ID: NCT01573598
Last Updated: 2015-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1219 participants
INTERVENTIONAL
2012-04-30
2015-01-31
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
TRIPLE
Study Groups
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Placebo
Dose-matched placebo capsules, oral administration
Placebo
Matching placebo given orally, once per day
Vilazodone 20mg
Vilazodone tablets, 20 mg per day, oral administration
Vilazodone
Vilazodone, 20 mg per day, oral administration
Vilazodone 40mg
Vilazodone tablets, 40 mg per day, oral administration
Vilazodone
Vilazodone, 40 mg once per day, oral administration
Interventions
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Placebo
Matching placebo given orally, once per day
Vilazodone
Vilazodone, 20 mg per day, oral administration
Vilazodone
Vilazodone, 40 mg once per day, oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
* The patient's current major depressive episode must be at least 8 weeks and no longer than 18 months in duration
Exclusion Criteria
* Patients with a history of meeting DSM-IV-TR criteria for:
* any manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode;
* any depressive episode with psychotic or catatonic features;
* panic disorder with or without agoraphobia;
* obsessive-compulsive disorder;
* Schizophrenia, schizoaffective, or other psychotic disorder;
* bulimia or anorexia nervosa;
* presence of borderline personality disorder or antisocial personality disorder; h. mental retardation, dementia, amnesia, or other cognitive disorders
* Patients who are considered a suicide risk
18 Years
70 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Carrie Reichley
Role: STUDY_DIRECTOR
Forest Research Institute, a subsidiary of Actavis plc.
Locations
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Forest Investigative Site 030
Beverly Hills, California, United States
Forest Investigative Site 012
Chino, California, United States
Forest Investigative Site 022
Costa Mesa, California, United States
Forest Investigative Site 017
Los Angeles, California, United States
Forest Investigative Site 005
Newport Beach, California, United States
Forest Investigative Site 027
Riverside, California, United States
Forest Investigative Site 026
San Diego, California, United States
Forest Investigative Site 016
Cromwell, Connecticut, United States
Forest Investigative Site 029
Hartford, Connecticut, United States
Forest Investigative Site 020
Doral, Florida, United States
Forest Investigative Site 007
Fort Lauderdale, Florida, United States
Forest Investigative Site 006
Fort Myers, Florida, United States
Forest Investigative Site 004
Hallandale, Florida, United States
Forest Investigative Site 039
Jacksonville, Florida, United States
Forest Investigative Site 008
Jacksonville Beach, Florida, United States
Forest Investigative Site 015
Leesburg, Florida, United States
Forest Investigative Site 035
Orlando, Florida, United States
Forest Investigative Site 001
West Palm Beach, Florida, United States
Forest Investigative Site 034
Winter Park, Florida, United States
Forest Investigative Site 019
Hoffman Estates, Illinois, United States
Forest Investigative Site 021
Indianapolis, Indiana, United States
Forest Investigative Site 003
Boston, Massachusetts, United States
Forest Investigative Site 013
Weymouth, Massachusetts, United States
Forest Investigative Site 028
Rochester Hills, Michigan, United States
Forest Investigative Site 038
Brooklyn, New York, United States
Forest Investigative Site 037
New York, New York, United States
Forest Investigative Site 032
New York, New York, United States
Forest Investigative Site 009
New York, New York, United States
Forest Investigative Site 014
Durham, North Carolina, United States
Forest Investigative Site 025
Oklahoma City, Oklahoma, United States
Forest Investigative Site 024
Oklahoma City, Oklahoma, United States
Forest Investigative Site 036
Memphis, Tennessee, United States
Forest Investigative Site 023
Dallas, Texas, United States
Forest Investigative Site 011
Houston, Texas, United States
Forest Investigative Site 010
Plano, Texas, United States
Forest Investigative Site 002
San Antonio, Texas, United States
Forest Investigative Site 031
Richmond, Virginia, United States
Forest Investigative Site 033
Bellevue, Washington, United States
Forest Investigative Site 103
Pleven, , Bulgaria
Forest Investigative Site 104
Plovdiv, , Bulgaria
Forest Investigative Site 106
Sofia, , Bulgaria
Forest Investigative Site 102
Sofia, , Bulgaria
Forest Investigative Site 304
Helsinki, Etelä-Suomen Lääni, Finland
Forest Investigative Site 305
Helsinki, Etelä-Suomen Lääni, Finland
Forest Investigative Site 301
Helsinki, Etelä-Suomen Lääni, Finland
Forest Investigative Site 303
Rauma, Länsi-Suomen Lääni, Finland
Forest Investigative Site 302
Kuopio, , Finland
Forest Investigative Site 306
Turku, , Finland
Forest Investigative Site 307
Turku, , Finland
Forest Investigative Site 401
Hanover, Lower Saxony, Germany
Forest Investigative Site 405
Dresden, Saxony, Germany
Forest Investigative Site 403
Berlin, , Germany
Forest Investigative Site 408
Berlin, , Germany
Forest Investigative Site 407
Chemnitz, , Germany
Forest Investigative Site 402
Hüttenberg, , Germany
Forest Investigative Site 409
Münster, , Germany
Forest Investigative Site 404
Nuremberg, , Germany
Forest Investigative Site 406
Westerstede, , Germany
Forest Investigative Site 602
Bucharest, București, Romania
Forest Investigative Site 601
Arad, , Romania
Forest Investigative Site 603
Iași, , Romania
Forest Investigative Site 705
Petrozavodsk, Kareliya, Respublika, Russia
Forest Investigative Site 701
Moscow, , Russia
Forest Investigative Site 804
Belgrade, Beograd, Serbia
Forest Investigative Site 806
Niš, Nišava, Serbia
Forest Investigative Site 801
Belgrade, , Serbia
Forest Investigative Site 802
Belgrade, , Serbia
Forest Investigative Site 803
Kragujevac, , Serbia
Forest Investigative Site 805
Kragujevac, Šumadija, Serbia
Forest Investigative Site 903
Kherson, Kherson Oblast, Ukraine
Forest Investigative Site 905
Luhansk, Luhansk Oblast, Ukraine
Forest Investigative Site 901
Lviv, Lviv Oblast, Ukraine
Forest Investigative Site 906
Odesa, Odesa Oblast, Ukraine
Forest Investigative Site 902
Dnipropetrovsk, , Ukraine
Forest Investigative Site 904
Simferopol, , Ukraine
Countries
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Other Identifiers
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VLZ-MD-02
Identifier Type: -
Identifier Source: org_study_id
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