Clinical trial NCT01573598: Safety and Efficacy of Vilazodone in Major Depressive Disorder
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study With Vilazodone in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Depression
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2012-04-09
Enrollment: 1219
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety and Efficacy of Vilazodone in Major Depressive Disorder


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time to first relapse during the double-blind treatment phase
timeFrame: Number of days from the randomization date to the relapse date, up to 28 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Forest Investigative Site 030
state: California
city: Chino
country: United States
facility: Forest Investigative Site 012
state: California
city: Costa Mesa
country: United States
facility: Forest Investigative Site 022
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site 017
state: California
city: Newport Beach
country: United States
facility: Forest Investigative Site 005
state: California
city: Riverside
country: United States
facility: Forest Investigative Site 027
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 026
state: California
city: Cromwell
country: United States
facility: Forest Investigative Site 016
state: Connecticut
city: Hartford
country: United States
facility: Forest Investigative Site 029
state: Connecticut
city: Doral
country: United States
facility: Forest Investigative Site 020
state: Florida
city: Fort Myers
country: United States
facility: Forest Investigative Site 006
state: Florida
city: Ft. Lauderdale
country: United States
facility: Forest Investigative Site 007
state: Florida
city: Hallandale Beach
country: United States
facility: Forest Investigative Site 004
state: Florida
city: Jacksonville Beach
country: United States
facility: Forest Investigative Site 008
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 039
state: Florida
city: Leesburg
country: United States
facility: Forest Investigative Site 015
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 035
state: Florida
city: West Palm Beach
country: United States
facility: Forest Investigative Site 001
state: Florida
city: Winter Park
country: United States
facility: Forest Investigative Site 034
state: Florida
city: Hoffman Estates
country: United States
facility: Forest Investigative Site 019
state: Illinois
city: Indianapolis
country: United States
facility: Forest Investigative Site 021
state: Indiana
city: Boston
country: United States
facility: Forest Investigative Site 003
state: Massachusetts
city: Weymouth
country: United States
facility: Forest Investigative Site 013
state: Massachusetts
city: Rochester Hills
country: United States
facility: Forest Investigative Site 028
state: Michigan
city: Brooklyn
country: United States
facility: Forest Investigative Site 038
state: New York
city: New York
country: United States
facility: Forest Investigative Site 037
state: New York
city: New York
country: United States
facility: Forest Investigative Site 032
state: New York
city: New York
country: United States
facility: Forest Investigative Site 009
state: New York
city: Durham
country: United States
facility: Forest Investigative Site 014
state: North Carolina
city: Oklahoma City
country: United States
facility: Forest Investigative Site 025
state: Oklahoma
city: Oklahoma City
country: United States
facility: Forest Investigative Site 024
state: Oklahoma
city: Memphis
country: United States
facility: Forest Investigative Site 036
state: Tennessee
city: Dallas
country: United States
facility: Forest Investigative Site 023
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 011
state: Texas
city: Plano
country: United States
facility: Forest Investigative Site 010
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 002
state: Texas
city: Richmond
country: United States
facility: Forest Investigative Site 031
state: Virginia
city: Bellevue
country: United States
facility: Forest Investigative Site 033
state: Washington
city: Pleven
country: Bulgaria
facility: Forest Investigative Site 103
city: Plovdiv
country: Bulgaria
facility: Forest Investigative Site 104
city: Sofia
country: Bulgaria
facility: Forest Investigative Site 106
city: Sofia
country: Bulgaria
facility: Forest Investigative Site 102
city: Helsinki
country: Finland
facility: Forest Investigative Site 304
state: Etelä-Suomen lääni
city: Helsinki
country: Finland
facility: Forest Investigative Site 305
state: Etelä-Suomen lääni
city: Helsinki
country: Finland
facility: Forest Investigative Site 301
state: Etelä-Suomen lääni
city: Rauma
country: Finland
facility: Forest Investigative Site 303
state: Länsi-Suomen lääni
city: Kuopio
country: Finland
facility: Forest Investigative Site 302
city: Turku
country: Finland
facility: Forest Investigative Site 306
city: Turku
country: Finland
facility: Forest Investigative Site 307
city: Hannover
country: Germany
facility: Forest Investigative Site 401
state: Niedersachsen
city: Dresden
country: Germany
facility: Forest Investigative Site 405
state: Sachsen
city: Berlin
country: Germany
facility: Forest Investigative Site 403
city: Berlin
country: Germany
facility: Forest Investigative Site 408
city: Chemnitz
country: Germany
facility: Forest Investigative Site 407
city: Hüttenberg
country: Germany
facility: Forest Investigative Site 402
city: Münster
country: Germany
facility: Forest Investigative Site 409
city: Nürnberg
country: Germany
facility: Forest Investigative Site 404
city: Westerstede
country: Germany
facility: Forest Investigative Site 406
city: Bucuresti
country: Romania
facility: Forest Investigative Site 602
state: Bucureşti
city: Arad
country: Romania
facility: Forest Investigative Site 601
city: Iasi
country: Romania
facility: Forest Investigative Site 603
city: Petrozavodsk
country: Russian Federation
facility: Forest Investigative Site 705
state: Kareliya, Respublika
city: Moscow
country: Russian Federation
facility: Forest Investigative Site 701
city: Belgrade
country: Serbia
facility: Forest Investigative Site 804
state: Beograd
city: Nis
country: Serbia
facility: Forest Investigative Site 806
state: Nišava
city: Beograd
country: Serbia
facility: Forest Investigative Site 801
city: Beograd
country: Serbia
facility: Forest Investigative Site 802
city: Kragujevac
country: Serbia
facility: Forest Investigative Site 803
city: Kragujevac
country: Serbia
facility: Forest Investigative Site 805
state: Šumadija
city: Kherson
country: Ukraine
facility: Forest Investigative Site 903
state: Khersons'ka Oblast'
city: Lviv
country: Ukraine
facility: Forest Investigative Site 901
state: L'vivs'ka Oblast'
city: Lugansk
country: Ukraine
facility: Forest Investigative Site 905
state: Luhans'ka Oblast'
city: Odesa
country: Ukraine
facility: Forest Investigative Site 906
state: Odes'ka Oblast'
city: Dnipropetrovsk
country: Ukraine
facility: Forest Investigative Site 902
city: Simferopol
country: Ukraine
facility: Forest Investigative Site 904
Study officials:
affiliation: Forest Research Institute, a subsidiary of Actavis plc.
name: Carrie Reichley
role: STUDY_DIRECTOR
References: