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Safety and Efficacy of Vilazodone in Major Depressive Disorder

Sponsor
Forest Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01573598
Collaborator
(none)
1,219
Enrollment
75
Locations
3
Arms
33
Duration (Months)
16.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Safety and Efficacy of Vilazodone in Major Depressive Disorder

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
1219 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study With Vilazodone in Patients With Major Depressive Disorder
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Dose-matched placebo capsules, oral administration

Drug: Placebo
Matching placebo given orally, once per day
Experimental: Vilazodone 20mg

Vilazodone tablets, 20 mg per day, oral administration

Drug: Vilazodone
Vilazodone, 20 mg per day, oral administration
Other Names:
  • Viibryd

    		•
    Experimental: Vilazodone 40mg

    Vilazodone tablets, 40 mg per day, oral administration

    Drug: Vilazodone
    Vilazodone, 40 mg once per day, oral administration
    Other Names:
  • Viibryd

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

    1. mental retardation, dementia, amnesia, or other cognitive disorders
    • Patients who are considered a suicide risk

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Forest Investigative Site 030 Beverly Hills California United States 90210
    2 Forest Investigative Site 012 Chino California United States 91710
    3 Forest Investigative Site 022 Costa Mesa California United States 92626
    4 Forest Investigative Site 017 Los Angeles California United States 90024
    5 Forest Investigative Site 005 Newport Beach California United States 92660
    6 Forest Investigative Site 027 Riverside California United States 92506
    7 Forest Investigative Site 026 San Diego California United States 92103
    8 Forest Investigative Site 016 Cromwell Connecticut United States 06416
    9 Forest Investigative Site 029 Hartford Connecticut United States 06106
    10 Forest Investigative Site 020 Doral Florida United States 33172
    11 Forest Investigative Site 006 Fort Myers Florida United States 33912
    12 Forest Investigative Site 007 Ft. Lauderdale Florida United States 33313
    13 Forest Investigative Site 004 Hallandale Beach Florida United States 33009
    14 Forest Investigative Site 008 Jacksonville Beach Florida United States 32250
    15 Forest Investigative Site 039 Jacksonville Florida United States 32256
    16 Forest Investigative Site 015 Leesburg Florida United States 34748
    17 Forest Investigative Site 035 Orlando Florida United States 32806
    18 Forest Investigative Site 001 West Palm Beach Florida United States 33407
    19 Forest Investigative Site 034 Winter Park Florida United States 32789
    20 Forest Investigative Site 019 Hoffman Estates Illinois United States 60169
    21 Forest Investigative Site 021 Indianapolis Indiana United States 46260
    22 Forest Investigative Site 003 Boston Massachusetts United States 02131
    23 Forest Investigative Site 013 Weymouth Massachusetts United States 02190
    24 Forest Investigative Site 028 Rochester Hills Michigan United States 48307
    25 Forest Investigative Site 038 Brooklyn New York United States 11214
    26 Forest Investigative Site 037 New York New York United States 10003
    27 Forest Investigative Site 032 New York New York United States 10021
    28 Forest Investigative Site 009 New York New York United States 10032
    29 Forest Investigative Site 014 Durham North Carolina United States 27705
    30 Forest Investigative Site 025 Oklahoma City Oklahoma United States 73103
    31 Forest Investigative Site 024 Oklahoma City Oklahoma United States 73112
    32 Forest Investigative Site 036 Memphis Tennessee United States 38119
    33 Forest Investigative Site 023 Dallas Texas United States 75080
    34 Forest Investigative Site 011 Houston Texas United States 77079
    35 Forest Investigative Site 010 Plano Texas United States 75093
    36 Forest Investigative Site 002 San Antonio Texas United States 78229
    37 Forest Investigative Site 031 Richmond Virginia United States 23298
    38 Forest Investigative Site 033 Bellevue Washington United States 98007
    39 Forest Investigative Site 103 Pleven Bulgaria 5800
    40 Forest Investigative Site 104 Plovdiv Bulgaria 4002
    41 Forest Investigative Site 106 Sofia Bulgaria 1000
    42 Forest Investigative Site 102 Sofia Bulgaria 1632
    43 Forest Investigative Site 304 Helsinki Etelä-Suomen lääni Finland 00100
    44 Forest Investigative Site 305 Helsinki Etelä-Suomen lääni Finland 00100
    45 Forest Investigative Site 301 Helsinki Etelä-Suomen lääni Finland FI-02600
    46 Forest Investigative Site 303 Rauma Länsi-Suomen lääni Finland FI-26100
    47 Forest Investigative Site 302 Kuopio Finland 70110
    48 Forest Investigative Site 306 Turku Finland 20100
    49 Forest Investigative Site 307 Turku Finland 20100
    50 Forest Investigative Site 401 Hannover Niedersachsen Germany 30159
    51 Forest Investigative Site 405 Dresden Sachsen Germany 1069
    52 Forest Investigative Site 403 Berlin Germany 10629
    53 Forest Investigative Site 408 Berlin Germany 13156
    54 Forest Investigative Site 407 Chemnitz Germany 09111
    55 Forest Investigative Site 402 Hüttenberg Germany 35625
    56 Forest Investigative Site 409 Münster Germany 48129
    57 Forest Investigative Site 404 Nürnberg Germany 90419
    58 Forest Investigative Site 406 Westerstede Germany 26655
    59 Forest Investigative Site 602 Bucuresti Bucureşti Romania 7000
    60 Forest Investigative Site 601 Arad Romania 310022
    61 Forest Investigative Site 603 Iasi Romania 700282
    62 Forest Investigative Site 705 Petrozavodsk Kareliya, Respublika Russian Federation 185001
    63 Forest Investigative Site 701 Moscow Russian Federation 115419
    64 Forest Investigative Site 804 Belgrade Beograd Serbia 11000
    65 Forest Investigative Site 806 Nis Nišava Serbia 18000
    66 Forest Investigative Site 801 Beograd Serbia 11000
    67 Forest Investigative Site 802 Beograd Serbia 11000
    68 Forest Investigative Site 803 Kragujevac Serbia 34000
    69 Forest Investigative Site 805 Kragujevac Šumadija Serbia 34000
    70 Forest Investigative Site 903 Kherson Khersons'ka Oblast' Ukraine 73488
    71 Forest Investigative Site 901 Lviv L'vivs'ka Oblast' Ukraine 79021
    72 Forest Investigative Site 905 Lugansk Luhans'ka Oblast' Ukraine 91045
    73 Forest Investigative Site 906 Odesa Odes'ka Oblast' Ukraine 67513
    74 Forest Investigative Site 902 Dnipropetrovsk Ukraine 49005
    75 Forest Investigative Site 904 Simferopol Ukraine 95006

    Sponsors and Collaborators

    • Forest Laboratories

    Investigators

    • Study Director: Carrie Reichley, Forest Research Institute, a subsidiary of Actavis plc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Forest Laboratories
    ClinicalTrials.gov Identifier:
    NCT01573598
    Other Study ID Numbers:
    • VLZ-MD-02
    First Posted:
    Apr 9, 2012
    Last Update Posted:
    May 18, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by Forest Laboratories
    Major Depressive Disorder
    Depression
    Additional relevant MeSH terms:
    Disease
    Depressive Disorder
    Depression
    Depressive Disorder, Major
    Vilazodone Hydrochloride

    Study Results

    No Results Posted as of May 18, 2015