Safety and Efficacy of Vilazodone in Major Depressive Disorder
NCT ID: NCT01473381
Last Updated: 2014-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1162 participants
INTERVENTIONAL
2011-12-31
2013-06-30
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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Placebo
Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
Placebo to citalopram
Placebo to citalopram was supplied as a capsule.
Placebo to vilazodone
Placebo to vilazodone was supplied as film-coated tablets.
Vilazodone 20 mg/day
Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
Vilazodone
Vilazodone was supplied as film-coated tablets.
Placebo to citalopram
Placebo to citalopram was supplied as a capsule.
Placebo to vilazodone
Placebo to vilazodone was supplied as film-coated tablets.
Vilazodone 40 mg/day
Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
Vilazodone
Vilazodone was supplied as film-coated tablets.
Placebo to citalopram
Placebo to citalopram was supplied as a capsule.
Placebo to vilazodone
Placebo to vilazodone was supplied as film-coated tablets.
Citalopram 40 mg/day
Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
Placebo to vilazodone
Placebo to vilazodone was supplied as film-coated tablets.
Citalopram
Citalopram was supplied as encapsulated tablets.
Interventions
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Vilazodone
Vilazodone was supplied as film-coated tablets.
Placebo to citalopram
Placebo to citalopram was supplied as a capsule.
Placebo to vilazodone
Placebo to vilazodone was supplied as film-coated tablets.
Citalopram
Citalopram was supplied as encapsulated 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 036
Birmingham, Alabama, United States
Forest Investigative Site 016
Dothan, Alabama, United States
Forest Investigative Site 033
Scottsdale, Arizona, United States
Forest Investigative Site 027
Fayetteville, Arkansas, United States
Forest Investigative Site 029
Cerritos, California, United States
Forest Investigative Site 002
Costa Mesa, California, United States
Forest Investigative Site 019
Murrieta, California, United States
Forest Investigative Site 025
Oceanside, California, United States
Forest Investigative Site 043
Orange, California, United States
Forest Investigative Site 003
Redlands, California, United States
Forest Investigative Site 046
Sherman Oaks, California, United States
Forest Investigative Site 057
Upland, California, United States
Forest Investigative Site 034
Cromwell, Connecticut, United States
Forest Investigative Site 038
Fort Myers, Florida, United States
Forest Investigative Site 018
Gainsville, Florida, United States
Forest Investigative Site 055
Hallandale, Florida, United States
Forest Investigative Site 063
Jacksonville, Florida, United States
Forest Investigative Site 035
Miami, Florida, United States
Forest Investigative Site 030
Orlando, Florida, United States
Forest Investigative Site 062
Orlando, Florida, United States
Forest Investigative Site 045
Pembroke Pines, Florida, United States
Forest Investigative Site 051
Tampa, Florida, United States
Forest Investigative Site 032
West Palm Beach, Florida, United States
Forest Investigative Site 022
Winter Park, Florida, United States
Forest Investigative Site 060
Atlanta, Georgia, United States
Forest Investigative Site 037
Chicago, Illinois, United States
Forest Investigative Site 050
Chicago, Illinois, United States
Forest Investigative Site 040
Indianapolis, Indiana, United States
Forest Investigative Site 012
Lafayette, Indiana, United States
Forest Investigative Site 053
Prairie Village, Kansas, United States
Forest Investigative Site 020
Baltimore, Maryland, United States
Forest Investigative Site 031
Boston, Massachusetts, United States
Forest Investigative Site 061
Las Vegas, Nevada, United States
Forest Investigative Site 024
Willingboro, New Jersey, United States
Forest Investigative Site 010
Albuquerque, New Mexico, United States
Forest Investigative Site 011
Albuquerque, New Mexico, United States
Forest Investigative Site 004
Brooklyn, New York, United States
Forest Investigative Site 007
Cedarhurst, New York, United States
Forest Investigative Site 058
New York, New York, United States
Forest Investigative Site 047
New York, New York, United States
Forest Investigative Site 039
Cincinnati, Ohio, United States
Forest Investigative Site 042
Oklahoma City, Oklahoma, United States
Forest Investigative Site 048
Oklahoma City, Oklahoma, United States
Forest Investigative Site 066
Portland, Oregon, United States
Forest Investigative Site 014
Allentown, Pennsylvania, United States
Forest Investigative Site 049
Bridgeville, Pennsylvania, United States
Forest Investigative Site 064
Memphis, Tennessee, United States
Forest Investigative Site 013
Austin, Texas, United States
Forest Investigative Site 021
Dallas, Texas, United States
Forest Investigative Site 059
Bellevue, Washington, United States
Forest Investigative Site 065
Seattle, Washington, United States
Forest Investigative Site 054
Spokane, Washington, United States
Forest Investigative Site 052
Middleton, Wisconsin, United States
Forest Investigative Site 056
Milwaukee, Wisconsin, 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.
Rele S, Millet R, Kim S, Paik JW, Kim S, Masand PS, Patkar AA. An 8-Week Randomized, Double-Blind Trial Comparing Efficacy, Safety, and Tolerability of 3 Vilazodone Dose-Initiation Strategies Following Switch From SSRIs and SNRIs in Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Aug 6;17(4):10.4088/PCC.14m01734. doi: 10.4088/PCC.14m01734. eCollection 2015.
Clayton AH, Gommoll C, Chen D, Nunez R, Mathews M. Sexual dysfunction during treatment of major depressive disorder with vilazodone, citalopram, or placebo: results from a phase IV clinical trial. Int Clin Psychopharmacol. 2015 Jul;30(4):216-23. doi: 10.1097/YIC.0000000000000075.
Mathews M, Gommoll C, Chen D, Nunez R, Khan A. Efficacy and safety of vilazodone 20 and 40 mg in major depressive disorder: a randomized, double-blind, placebo-controlled trial. Int Clin Psychopharmacol. 2015 Mar;30(2):67-74. doi: 10.1097/YIC.0000000000000057.
Other Identifiers
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VLZ-MD-01
Identifier Type: -
Identifier Source: org_study_id
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