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Safety and Efficacy of Vilazodone in Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Placebo
Vilazodone
Vilazodone
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Forest Investigative Site 030
  • Forest Investigative Site 012
  • Forest Investigative Site 022
  • Forest Investigative Site 017
  • Forest Investigative Site 005
  • Forest Investigative Site 027
  • Forest Investigative Site 026
  • Forest Investigative Site 016
  • Forest Investigative Site 029
  • Forest Investigative Site 020
  • Forest Investigative Site 006
  • Forest Investigative Site 007
  • Forest Investigative Site 004
  • Forest Investigative Site 008
  • Forest Investigative Site 039
  • Forest Investigative Site 015
  • Forest Investigative Site 035
  • Forest Investigative Site 001
  • Forest Investigative Site 034
  • Forest Investigative Site 019
  • Forest Investigative Site 021
  • Forest Investigative Site 003
  • Forest Investigative Site 013
  • Forest Investigative Site 028
  • Forest Investigative Site 038
  • Forest Investigative Site 037
  • Forest Investigative Site 032
  • Forest Investigative Site 009
  • Forest Investigative Site 014
  • Forest Investigative Site 025
  • Forest Investigative Site 024
  • Forest Investigative Site 036
  • Forest Investigative Site 023
  • Forest Investigative Site 011
  • Forest Investigative Site 010
  • Forest Investigative Site 002
  • Forest Investigative Site 031
  • Forest Investigative Site 033
  • Forest Investigative Site 103
  • Forest Investigative Site 104
  • Forest Investigative Site 106
  • Forest Investigative Site 102
  • Forest Investigative Site 304
  • Forest Investigative Site 305
  • Forest Investigative Site 301
  • Forest Investigative Site 303
  • Forest Investigative Site 302
  • Forest Investigative Site 306
  • Forest Investigative Site 307
  • Forest Investigative Site 401
  • Forest Investigative Site 405
  • Forest Investigative Site 403
  • Forest Investigative Site 408
  • Forest Investigative Site 407
  • Forest Investigative Site 402
  • Forest Investigative Site 409
  • Forest Investigative Site 404
  • Forest Investigative Site 406
  • Forest Investigative Site 602
  • Forest Investigative Site 601
  • Forest Investigative Site 603
  • Forest Investigative Site 705
  • Forest Investigative Site 701
  • Forest Investigative Site 804
  • Forest Investigative Site 806
  • Forest Investigative Site 801
  • Forest Investigative Site 802
  • Forest Investigative Site 803
  • Forest Investigative Site 805
  • Forest Investigative Site 903
  • Forest Investigative Site 901
  • Forest Investigative Site 905
  • Forest Investigative Site 906
  • Forest Investigative Site 902
  • Forest Investigative Site 904

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Vilazodone 20mg

Vilazodone 40mg

Arm Description

Dose-matched placebo capsules, oral administration

Vilazodone tablets, 20 mg per day, oral administration

Vilazodone tablets, 40 mg per day, oral administration

Outcomes

Primary Outcome Measures

Time to first relapse during the double-blind treatment phase

Secondary Outcome Measures

Full Information

First Posted
April 4, 2012
Last Updated
May 15, 2015
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01573598
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Safety and Efficacy of Vilazodone in Major Depressive Disorder

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dose-matched placebo capsules, oral administration
Arm Title
Vilazodone 20mg
Arm Type
Experimental
Arm Description
Vilazodone tablets, 20 mg per day, oral administration
Arm Title
Vilazodone 40mg
Arm Type
Experimental
Arm Description
Vilazodone tablets, 40 mg per day, oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo given orally, once per day
Intervention Type
Drug
Intervention Name(s)
Vilazodone
Other Intervention Name(s)
Viibryd
Intervention Description
Vilazodone, 20 mg per day, oral administration
Intervention Type
Drug
Intervention Name(s)
Vilazodone
Other Intervention Name(s)
Viibryd
Intervention Description
Vilazodone, 40 mg once per day, oral administration
Primary Outcome Measure Information:
Title
Time to first relapse during the double-blind treatment phase
Time Frame
Number of days from the randomization date to the relapse date, up to 28 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carrie Reichley
Organizational Affiliation
Forest Research Institute, a subsidiary of Actavis plc.
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 030
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Forest Investigative Site 012
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Forest Investigative Site 022
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Forest Investigative Site 017
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Forest Investigative Site 005
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Forest Investigative Site 027
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Forest Investigative Site 026
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Forest Investigative Site 016
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Forest Investigative Site 029
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Forest Investigative Site 020
City
Doral
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Forest Investigative Site 006
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Forest Investigative Site 007
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Facility Name
Forest Investigative Site 004
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Forest Investigative Site 008
City
Jacksonville Beach
State/Province
Florida
ZIP/Postal Code
32250
Country
United States
Facility Name
Forest Investigative Site 039
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Forest Investigative Site 015
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Forest Investigative Site 035
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 001
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Forest Investigative Site 034
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Forest Investigative Site 019
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Forest Investigative Site 021
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Forest Investigative Site 003
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Forest Investigative Site 013
City
Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States
Facility Name
Forest Investigative Site 028
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Forest Investigative Site 038
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
Country
United States
Facility Name
Forest Investigative Site 037
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Forest Investigative Site 032
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Forest Investigative Site 009
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Forest Investigative Site 014
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Forest Investigative Site 025
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Forest Investigative Site 024
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Forest Investigative Site 036
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site 023
City
Dallas
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Forest Investigative Site 011
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Forest Investigative Site 010
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Forest Investigative Site 002
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site 031
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Forest Investigative Site 033
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Forest Investigative Site 103
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Forest Investigative Site 104
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Forest Investigative Site 106
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
Forest Investigative Site 102
City
Sofia
ZIP/Postal Code
1632
Country
Bulgaria
Facility Name
Forest Investigative Site 304
City
Helsinki
State/Province
Etelä-Suomen lääni
ZIP/Postal Code
00100
Country
Finland
Facility Name
Forest Investigative Site 305
City
Helsinki
State/Province
Etelä-Suomen lääni
ZIP/Postal Code
00100
Country
Finland
Facility Name
Forest Investigative Site 301
City
Helsinki
State/Province
Etelä-Suomen lääni
ZIP/Postal Code
FI-02600
Country
Finland
Facility Name
Forest Investigative Site 303
City
Rauma
State/Province
Länsi-Suomen lääni
ZIP/Postal Code
FI-26100
Country
Finland
Facility Name
Forest Investigative Site 302
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
Facility Name
Forest Investigative Site 306
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
Forest Investigative Site 307
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
Forest Investigative Site 401
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30159
Country
Germany
Facility Name
Forest Investigative Site 405
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
1069
Country
Germany
Facility Name
Forest Investigative Site 403
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Forest Investigative Site 408
City
Berlin
ZIP/Postal Code
13156
Country
Germany
Facility Name
Forest Investigative Site 407
City
Chemnitz
ZIP/Postal Code
09111
Country
Germany
Facility Name
Forest Investigative Site 402
City
Hüttenberg
ZIP/Postal Code
35625
Country
Germany
Facility Name
Forest Investigative Site 409
City
Münster
ZIP/Postal Code
48129
Country
Germany
Facility Name
Forest Investigative Site 404
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Forest Investigative Site 406
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Forest Investigative Site 602
City
Bucuresti
State/Province
Bucureşti
ZIP/Postal Code
7000
Country
Romania
Facility Name
Forest Investigative Site 601
City
Arad
ZIP/Postal Code
310022
Country
Romania
Facility Name
Forest Investigative Site 603
City
Iasi
ZIP/Postal Code
700282
Country
Romania
Facility Name
Forest Investigative Site 705
City
Petrozavodsk
State/Province
Kareliya, Respublika
ZIP/Postal Code
185001
Country
Russian Federation
Facility Name
Forest Investigative Site 701
City
Moscow
ZIP/Postal Code
115419
Country
Russian Federation
Facility Name
Forest Investigative Site 804
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Forest Investigative Site 806
City
Nis
State/Province
Nišava
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Forest Investigative Site 801
City
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Forest Investigative Site 802
City
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Forest Investigative Site 803
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Forest Investigative Site 805
City
Kragujevac
State/Province
Šumadija
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Forest Investigative Site 903
City
Kherson
State/Province
Khersons'ka Oblast'
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Forest Investigative Site 901
City
Lviv
State/Province
L'vivs'ka Oblast'
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Forest Investigative Site 905
City
Lugansk
State/Province
Luhans'ka Oblast'
ZIP/Postal Code
91045
Country
Ukraine
Facility Name
Forest Investigative Site 906
City
Odesa
State/Province
Odes'ka Oblast'
ZIP/Postal Code
67513
Country
Ukraine
Facility Name
Forest Investigative Site 902
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Forest Investigative Site 904
City
Simferopol
ZIP/Postal Code
95006
Country
Ukraine

12. IPD Sharing Statement

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Safety and Efficacy of Vilazodone in Major Depressive Disorder

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