Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder
NCT ID: NCT01473394
Last Updated: 2014-04-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
518 participants
INTERVENTIONAL
2011-12-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dose-matched placebo
Participants received dose-matched placebo orally once daily for 9 weeks.
Dose-matched placebo
Dose-matched placebo was supplied as tablets.
Vilazodone
Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
Vilazodone
Vilazodone was supplied as tablets.
Interventions
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Dose-matched placebo
Dose-matched placebo was supplied as tablets.
Vilazodone
Vilazodone was supplied as tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (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 12 months in duration.
Exclusion Criteria
* 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;
* mental retardation, dementia, amnesia, or other cognitive disorders;
* patients who are considered a suicide risk.
18 Years
70 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Carl Gommoll, MS
Role: STUDY_DIRECTOR
Forest Laboratories
Locations
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Forest Investigative Site 009
Beverly Hills, California, United States
Forest Investigative Site 003
Encino, California, United States
Forest Investigative Site 010
New Port Beach, California, United States
Forest Investigative Site 005
Jacksonville, Florida, United States
Forest Investigative Site 004
Orlando, Florida, United States
Forest Investigative Site 012
Atlanta, Georgia, United States
Forest Investigative Site 001
Baltimore, Maryland, United States
Forest Investigative Site 002
Dayton, Ohio, United States
Forest Investigative Site 011
Philadelphia, Pennsylvania, United States
Forest Investigative Site 015
Lincoln, Rhode Island, United States
Forest Investigative Site 008
Memphis, Tennessee, United States
Forest Investigative Site 016
San Antonio, Texas, United States
Forest Investigative Site 006
Bellevue, Washington, United States
Forest Investigative Site 013
Seattle, Washington, United States
Countries
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References
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Kornstein S, Chang CT, Gommoll CP, Edwards J. Vilazodone efficacy in subgroups of patients with major depressive disorder: a post-hoc analysis of four randomized, double-blind, placebo-controlled trials. Int Clin Psychopharmacol. 2018 Jul;33(4):217-223. doi: 10.1097/YIC.0000000000000217.
Croft HA, Pomara N, Gommoll C, Chen D, Nunez R, Mathews M. Efficacy and safety of vilazodone in major depressive disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2014 Nov;75(11):e1291-8. doi: 10.4088/JCP.14m08992.
Citrome L, Gommoll CP, Tang X, Nunez R, Mathews M. Evaluating the efficacy of vilazodone in achieving remission in patients with major depressive disorder: post-hoc analyses of a phase IV trial. Int Clin Psychopharmacol. 2015 Mar;30(2):75-81. doi: 10.1097/YIC.0000000000000056.
Other Identifiers
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VLZ-MD-03
Identifier Type: -
Identifier Source: org_study_id
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