Safety and Efficacy of Vilazodone in Major Depressive Disorder
- Registration Number
- NCT01573598
- Lead Sponsor
- Forest Laboratories
- Brief Summary
Safety and Efficacy of Vilazodone in Major Depressive Disorder
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1219
- Men and women, 18-70 years of age
- 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
-
Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Dose-matched placebo capsules, oral administration Vilazodone 20mg Vilazodone Vilazodone tablets, 20 mg per day, oral administration Vilazodone 40mg Vilazodone Vilazodone tablets, 40 mg per day, oral administration
- Primary Outcome Measures
Name Time Method Time to first relapse during the double-blind treatment phase Number of days from the randomization date to the relapse date, up to 28 weeks.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (75)
Forest Investigative Site 016
🇺🇸Cromwell, Connecticut, United States
Forest Investigative Site 034
🇺🇸Winter Park, Florida, United States
Forest Investigative Site 006
🇺🇸Fort Myers, Florida, United States
Forest Investigative Site 003
🇺🇸Boston, Massachusetts, United States
Forest Investigative Site 012
🇺🇸Chino, California, United States
Forest Investigative Site 022
🇺🇸Costa Mesa, California, United States
Forest Investigative Site 030
🇺🇸Beverly Hills, 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 020
🇺🇸Doral, Florida, United States
Forest Investigative Site 029
🇺🇸Hartford, Connecticut, United States
Forest Investigative Site 007
🇺🇸Ft. Lauderdale, Florida, United States
Forest Investigative Site 004
🇺🇸Hallandale Beach, 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 019
🇺🇸Hoffman Estates, Illinois, United States
Forest Investigative Site 038
🇺🇸Brooklyn, New York, United States
Forest Investigative Site 028
🇺🇸Rochester Hills, Michigan, United States
Forest Investigative Site 013
🇺🇸Weymouth, Massachusetts, 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 023
🇺🇸Dallas, Texas, United States
Forest Investigative Site 036
🇺🇸Memphis, Tennessee, United States
Forest Investigative Site 031
🇺🇸Richmond, Virginia, United States
Forest Investigative Site 010
🇺🇸Plano, Texas, United States
Forest Investigative Site 033
🇺🇸Bellevue, Washington, United States
Forest Investigative Site 104
🇧🇬Plovdiv, Bulgaria
Forest Investigative Site 102
🇧🇬Sofia, Bulgaria
Forest Investigative Site 304
🇫🇮Helsinki, Etelä-Suomen lääni, Finland
Forest Investigative Site 301
🇫🇮Helsinki, Etelä-Suomen lääni, Finland
Forest Investigative Site 307
🇫🇮Turku, Finland
Forest Investigative Site 402
🇩🇪Hüttenberg, Germany
Forest Investigative Site 401
🇩🇪Hannover, Niedersachsen, Germany
Forest Investigative Site 403
🇩🇪Berlin, Germany
Forest Investigative Site 405
🇩🇪Dresden, Sachsen, Germany
Forest Investigative Site 408
🇩🇪Berlin, Germany
Forest Investigative Site 409
🇩🇪Münster, Germany
Forest Investigative Site 701
🇷🇺Moscow, Russian Federation
Forest Investigative Site 404
🇩🇪Nürnberg, Germany
Forest Investigative Site 406
🇩🇪Westerstede, Germany
Forest Investigative Site 601
🇷🇴Arad, Romania
Forest Investigative Site 602
🇷🇴Bucuresti, Bucureşti, Romania
Forest Investigative Site 705
🇷🇺Petrozavodsk, Kareliya, Respublika, Russian Federation
Forest Investigative Site 804
🇷🇸Belgrade, Beograd, Serbia
Forest Investigative Site 802
🇷🇸Beograd, Serbia
Forest Investigative Site 903
🇺🇦Kherson, Khersons'ka Oblast', Ukraine
Forest Investigative Site 901
🇺🇦Lviv, L'vivs'ka Oblast', Ukraine
Forest Investigative Site 906
🇺🇦Odesa, Odes'ka Oblast', Ukraine
Forest Investigative Site 905
🇺🇦Lugansk, Luhans'ka Oblast', Ukraine
Forest Investigative Site 902
🇺🇦Dnipropetrovsk, Ukraine
Forest Investigative Site 904
🇺🇦Simferopol, Ukraine
Forest Investigative Site 026
🇺🇸San Diego, California, United States
Forest Investigative Site 021
🇺🇸Indianapolis, Indiana, 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 011
🇺🇸Houston, Texas, United States
Forest Investigative Site 002
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 302
🇫🇮Kuopio, Finland
Forest Investigative Site 801
🇷🇸Beograd, Serbia
Forest Investigative Site 407
🇩🇪Chemnitz, Germany
Forest Investigative Site 805
🇷🇸Kragujevac, Šumadija, Serbia
Forest Investigative Site 103
🇧🇬Pleven, Bulgaria
Forest Investigative Site 303
🇫🇮Rauma, Länsi-Suomen lääni, Finland
Forest Investigative Site 603
🇷🇴Iasi, Romania
Forest Investigative Site 305
🇫🇮Helsinki, Etelä-Suomen lääni, Finland
Forest Investigative Site 806
🇷🇸Nis, Nišava, Serbia
Forest Investigative Site 106
🇧🇬Sofia, Bulgaria
Forest Investigative Site 306
🇫🇮Turku, Finland
Forest Investigative Site 803
🇷🇸Kragujevac, Serbia