ClinicalTrials.gg
CompletedNCT01573598Updated May 18, 2015

Safety and Efficacy of Vilazodone in Major Depressive Disorder

A Phase 4 interventional study of Placebo and Vilazodone in Major Depressive Disorder, sponsored by Forest Laboratories. Completed at 75 sites in 8 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-05-18.

Sponsored by Forest Laboratories (part of AbbVie) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
1,219
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Safety and Efficacy of Vilazodone in Major Depressive Disorder

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • Major Depressive Disorder
  • Depression
03

In context

Depressive Disorder, Major

2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.

This study's enrollment of 1,219 is above the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Forest Laboratories is the lead sponsor of 168 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

First submitted before Forest Laboratories became part of AbbVie.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
1,219 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Dose-matched placebo capsules, oral administration

    Drug: Placebo

  • Experimental
    Vilazodone 20mg

    Vilazodone tablets, 20 mg per day, oral administration

    Drug: Vilazodone

  • Experimental
    Vilazodone 40mg

    Vilazodone tablets, 40 mg per day, oral administration

    Drug: Vilazodone

Interventions

  • DrugPlacebo

    Matching placebo given orally, once per day

  • Vilazodone, 20 mg per day, oral administration

    Also known as: Viibryd

  • Vilazodone, 40 mg once per day, oral administration

    Also known as: Viibryd

06

What researchers measure

Primary outcomes

  1. 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.

07

Study locations

75 sites
  • Forest Investigative Site 030
    Beverly Hills, California 90210, United States
  • Forest Investigative Site 012
    Chino, California 91710, United States
  • Forest Investigative Site 022
    Costa Mesa, California 92626, United States
  • Forest Investigative Site 017
    Los Angeles, California 90024, United States
  • Forest Investigative Site 005
    Newport Beach, California 92660, United States
  • Forest Investigative Site 027
    Riverside, California 92506, United States
  • Forest Investigative Site 026
    San Diego, California 92103, United States
  • Forest Investigative Site 016
    Cromwell, Connecticut 06416, United States
  • Forest Investigative Site 029
    Hartford, Connecticut 06106, United States
  • Forest Investigative Site 020
    Doral, Florida 33172, United States
  • Forest Investigative Site 007
    Fort Lauderdale, Florida 33313, United States
  • Forest Investigative Site 006
    Fort Myers, Florida 33912, United States
  • Forest Investigative Site 004
    Hallandale, Florida 33009, United States
  • Forest Investigative Site 039
    Jacksonville, Florida 32256, United States
  • Forest Investigative Site 008
    Jacksonville Beach, Florida 32250, United States
  • Forest Investigative Site 015
    Leesburg, Florida 34748, United States
  • Forest Investigative Site 035
    Orlando, Florida 32806, United States
  • Forest Investigative Site 001
    West Palm Beach, Florida 33407, United States
  • Forest Investigative Site 034
    Winter Park, Florida 32789, United States
  • Forest Investigative Site 019
    Hoffman Estates, Illinois 60169, United States
  • Forest Investigative Site 021
    Indianapolis, Indiana 46260, United States
  • Forest Investigative Site 003
    Boston, Massachusetts 02131, United States
  • Forest Investigative Site 013
    Weymouth, Massachusetts 02190, United States
  • Forest Investigative Site 028
    Rochester Hills, Michigan 48307, United States
  • Forest Investigative Site 038
    Brooklyn, New York 11214, United States
  • Forest Investigative Site 037
    New York, New York 10003, United States
  • Forest Investigative Site 032
    New York, New York 10021, United States
  • Forest Investigative Site 009
    New York, New York 10032, United States
  • Forest Investigative Site 014
    Durham, North Carolina 27705, United States
  • Forest Investigative Site 025
    Oklahoma City, Oklahoma 73103, United States
  • Forest Investigative Site 024
    Oklahoma City, Oklahoma 73112, United States
  • Forest Investigative Site 036
    Memphis, Tennessee 38119, United States
  • Forest Investigative Site 023
    Dallas, Texas 75080, United States
  • Forest Investigative Site 011
    Houston, Texas 77079, United States
  • Forest Investigative Site 010
    Plano, Texas 75093, United States
  • Forest Investigative Site 002
    San Antonio, Texas 78229, United States
  • Forest Investigative Site 031
    Richmond, Virginia 23298, United States
  • Forest Investigative Site 033
    Bellevue, Washington 98007, United States
  • Forest Investigative Site 103
    Pleven, 5800, Bulgaria
  • Forest Investigative Site 104
    Plovdiv, 4002, Bulgaria
  • Forest Investigative Site 106
    Sofia, 1000, Bulgaria
  • Forest Investigative Site 102
    Sofia, 1632, Bulgaria
  • Forest Investigative Site 304
    Helsinki, Etelä-Suomen Lääni 00100, Finland
  • Forest Investigative Site 305
    Helsinki, Etelä-Suomen Lääni 00100, Finland
  • Forest Investigative Site 301
    Helsinki, Etelä-Suomen Lääni FI-02600, Finland
  • Forest Investigative Site 303
    Rauma, Länsi-Suomen Lääni FI-26100, Finland
  • Forest Investigative Site 302
    Kuopio, 70110, Finland
  • Forest Investigative Site 306
    Turku, 20100, Finland
  • Forest Investigative Site 307
    Turku, 20100, Finland
  • Forest Investigative Site 401
    Hanover, Lower Saxony 30159, Germany
  • Forest Investigative Site 405
    Dresden, Saxony 1069, Germany
  • Forest Investigative Site 403
    Berlin, 10629, Germany
  • Forest Investigative Site 408
    Berlin, 13156, Germany
  • Forest Investigative Site 407
    Chemnitz, 09111, Germany
  • Forest Investigative Site 402
    Hüttenberg, 35625, Germany
  • Forest Investigative Site 409
    Münster, 48129, Germany
  • Forest Investigative Site 404
    Nuremberg, 90419, Germany
  • Forest Investigative Site 406
    Westerstede, 26655, Germany
  • Forest Investigative Site 602
    Bucharest, Bucharest 7000, Romania
  • Forest Investigative Site 601
    Arad, 310022, Romania
  • Forest Investigative Site 603
    Iași, 700282, Romania
  • Forest Investigative Site 705
    Petrozavodsk, Kareliya, Respublika 185001, Russia
  • Forest Investigative Site 701
    Moscow, 115419, Russia
  • Forest Investigative Site 804
    Belgrade, Beograd 11000, Serbia
  • Forest Investigative Site 806
    Niš, Nišava 18000, Serbia
  • Forest Investigative Site 801
    Belgrade, 11000, Serbia
  • Forest Investigative Site 802
    Belgrade, 11000, Serbia
  • Forest Investigative Site 803
    Kragujevac, 34000, Serbia
  • Forest Investigative Site 805
    Kragujevac, Šumadija 34000, Serbia
  • Forest Investigative Site 903
    Kherson, Kherson Oblast 73488, Ukraine
  • Forest Investigative Site 905
    Luhansk, Luhansk Oblast 91045, Ukraine
  • Forest Investigative Site 901
    Lviv, Lviv Oblast 79021, Ukraine
  • Forest Investigative Site 906
    Odesa, Odesa Oblast 67513, Ukraine
  • Forest Investigative Site 902
    Dnipropetrovsk, 49005, Ukraine
  • Forest Investigative Site 904
    Simferopol, 95006, Ukraine
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2012, a primary completion of Oct 2014 and a completion of Jan 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 4, 2012
First posted
Apr 9, 2012
Start
Apr 2012
Primary completionActual
Oct 2014
CompletionActual
Jan 2015
Last update
May 18, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01573598
Responsible party
Sponsor
First posted
Apr 9, 2012
Start date
Apr 2012
Primary completion
Oct 2014
Completion
Jan 2015
Last update
May 18, 2015

Study contacts

Carrie Reichley
study director · Forest Research Institute, a subsidiary of Actavis plc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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