- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01573598
Safety and Efficacy of Vilazodone in Major Depressive Disorder
May 15, 2015 updated by: Forest Laboratories
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study With Vilazodone in Patients With Major Depressive Disorder
Safety and Efficacy of Vilazodone in Major Depressive Disorder
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1219
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pleven, Bulgaria, 5800
- Forest Investigative Site 103
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Plovdiv, Bulgaria, 4002
- Forest Investigative Site 104
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Sofia, Bulgaria, 1000
- Forest Investigative Site 106
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Sofia, Bulgaria, 1632
- Forest Investigative Site 102
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Kuopio, Finland, 70110
- Forest Investigative Site 302
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Turku, Finland, 20100
- Forest Investigative Site 306
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Turku, Finland, 20100
- Forest Investigative Site 307
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Etelä-Suomen lääni
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Helsinki, Etelä-Suomen lääni, Finland, 00100
- Forest Investigative Site 304
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Helsinki, Etelä-Suomen lääni, Finland, 00100
- Forest Investigative Site 305
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Helsinki, Etelä-Suomen lääni, Finland, FI-02600
- Forest Investigative Site 301
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Länsi-Suomen lääni
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Rauma, Länsi-Suomen lääni, Finland, FI-26100
- Forest Investigative Site 303
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Berlin, Germany, 10629
- Forest Investigative Site 403
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Berlin, Germany, 13156
- Forest Investigative Site 408
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Chemnitz, Germany, 09111
- Forest Investigative Site 407
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Hüttenberg, Germany, 35625
- Forest Investigative Site 402
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Münster, Germany, 48129
- Forest Investigative Site 409
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Nürnberg, Germany, 90419
- Forest Investigative Site 404
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Westerstede, Germany, 26655
- Forest Investigative Site 406
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Niedersachsen
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Hannover, Niedersachsen, Germany, 30159
- Forest Investigative Site 401
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Sachsen
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Dresden, Sachsen, Germany, 1069
- Forest Investigative Site 405
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Arad, Romania, 310022
- Forest Investigative Site 601
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Iasi, Romania, 700282
- Forest Investigative Site 603
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Bucureşti
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Bucuresti, Bucureşti, Romania, 7000
- Forest Investigative Site 602
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Moscow, Russian Federation, 115419
- Forest Investigative Site 701
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Kareliya, Respublika
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Petrozavodsk, Kareliya, Respublika, Russian Federation, 185001
- Forest Investigative Site 705
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Beograd, Serbia, 11000
- Forest Investigative Site 801
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Beograd, Serbia, 11000
- Forest Investigative Site 802
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Kragujevac, Serbia, 34000
- Forest Investigative Site 803
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Beograd
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Belgrade, Beograd, Serbia, 11000
- Forest Investigative Site 804
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Nišava
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Nis, Nišava, Serbia, 18000
- Forest Investigative Site 806
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Šumadija
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Kragujevac, Šumadija, Serbia, 34000
- Forest Investigative Site 805
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Dnipropetrovsk, Ukraine, 49005
- Forest Investigative Site 902
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Simferopol, Ukraine, 95006
- Forest Investigative Site 904
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Khersons'ka Oblast'
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Kherson, Khersons'ka Oblast', Ukraine, 73488
- Forest Investigative Site 903
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L'vivs'ka Oblast'
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Lviv, L'vivs'ka Oblast', Ukraine, 79021
- Forest Investigative Site 901
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Luhans'ka Oblast'
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Lugansk, Luhans'ka Oblast', Ukraine, 91045
- Forest Investigative Site 905
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Odes'ka Oblast'
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Odesa, Odes'ka Oblast', Ukraine, 67513
- Forest Investigative Site 906
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California
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Beverly Hills, California, United States, 90210
- Forest Investigative Site 030
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Chino, California, United States, 91710
- Forest Investigative Site 012
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Costa Mesa, California, United States, 92626
- Forest Investigative Site 022
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Los Angeles, California, United States, 90024
- Forest Investigative Site 017
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Newport Beach, California, United States, 92660
- Forest Investigative Site 005
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Riverside, California, United States, 92506
- Forest Investigative Site 027
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San Diego, California, United States, 92103
- Forest Investigative Site 026
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Connecticut
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Cromwell, Connecticut, United States, 06416
- Forest Investigative Site 016
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Hartford, Connecticut, United States, 06106
- Forest Investigative Site 029
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Florida
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Doral, Florida, United States, 33172
- Forest Investigative Site 020
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Fort Myers, Florida, United States, 33912
- Forest Investigative Site 006
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Ft. Lauderdale, Florida, United States, 33313
- Forest Investigative Site 007
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Hallandale Beach, Florida, United States, 33009
- Forest Investigative Site 004
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Jacksonville, Florida, United States, 32256
- Forest Investigative Site 039
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Jacksonville Beach, Florida, United States, 32250
- Forest Investigative Site 008
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Leesburg, Florida, United States, 34748
- Forest Investigative Site 015
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Orlando, Florida, United States, 32806
- Forest Investigative Site 035
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West Palm Beach, Florida, United States, 33407
- Forest Investigative Site 001
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Winter Park, Florida, United States, 32789
- Forest Investigative Site 034
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Illinois
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Hoffman Estates, Illinois, United States, 60169
- Forest Investigative Site 019
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Indiana
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Indianapolis, Indiana, United States, 46260
- Forest Investigative Site 021
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Massachusetts
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Boston, Massachusetts, United States, 02131
- Forest Investigative Site 003
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Weymouth, Massachusetts, United States, 02190
- Forest Investigative Site 013
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Michigan
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Rochester Hills, Michigan, United States, 48307
- Forest Investigative Site 028
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New York
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Brooklyn, New York, United States, 11214
- Forest Investigative Site 038
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New York, New York, United States, 10003
- Forest Investigative Site 037
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New York, New York, United States, 10021
- Forest Investigative Site 032
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New York, New York, United States, 10032
- Forest Investigative Site 009
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North Carolina
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Durham, North Carolina, United States, 27705
- Forest Investigative Site 014
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- Forest Investigative Site 025
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Oklahoma City, Oklahoma, United States, 73112
- Forest Investigative Site 024
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Tennessee
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Memphis, Tennessee, United States, 38119
- Forest Investigative Site 036
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Texas
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Dallas, Texas, United States, 75080
- Forest Investigative Site 023
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Houston, Texas, United States, 77079
- Forest Investigative Site 011
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Plano, Texas, United States, 75093
- Forest Investigative Site 010
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San Antonio, Texas, United States, 78229
- Forest Investigative Site 002
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Virginia
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Richmond, Virginia, United States, 23298
- Forest Investigative Site 031
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Washington
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Bellevue, Washington, United States, 98007
- Forest Investigative Site 033
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Dose-matched placebo capsules, oral administration
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Matching placebo given orally, once per day
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Experimental: Vilazodone 20mg
Vilazodone tablets, 20 mg per day, oral administration
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Vilazodone, 20 mg per day, oral administration
Other Names:
Vilazodone, 40 mg once per day, oral administration
Other Names:
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Experimental: Vilazodone 40mg
Vilazodone tablets, 40 mg per day, oral administration
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Vilazodone, 20 mg per day, oral administration
Other Names:
Vilazodone, 40 mg once per day, oral administration
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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.
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Number of days from the randomization date to the relapse date, up to 28 weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Carrie Reichley, Forest Research Institute, a subsidiary of Actavis plc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
April 4, 2012
First Submitted That Met QC Criteria
April 5, 2012
First Posted (Estimate)
April 9, 2012
Study Record Updates
Last Update Posted (Estimate)
May 18, 2015
Last Update Submitted That Met QC Criteria
May 15, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Depression
- Depressive Disorder
- Disease
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Vilazodone Hydrochloride
Other Study ID Numbers
- VLZ-MD-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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