Clinical trial NCT01473381: Safety and Efficacy of Vilazodone in Major Depressive Disorder
Official title: A Double-blind, Placebo- and Active-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Depression
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 1162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.


Eligibility criteria: Inclusion Criteria:

* Men and women, 18-70 years of age.
* 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:

* 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
  * Mental retardation, dementia, amnesia, or other cognitive disorders.
* Patients who are considered a suicide risk.

Primary outcomes:
measure: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10
timeFrame: Baseline to Week 10
Secondary outcomes:
measure: Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score
timeFrame: Baseline to Week 10
measure: Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response
timeFrame: Baseline to Week 10
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site 036
state: Alabama
city: Dothan
country: United States
facility: Forest Investigative Site 016
state: Alabama
city: Scottsdale
country: United States
facility: Forest Investigative Site 033
state: Arizona
city: Fayetteville
country: United States
facility: Forest Investigative Site 027
state: Arkansas
city: Cerritos
country: United States
facility: Forest Investigative Site 029
state: California
city: Costa Mesa
country: United States
facility: Forest Investigative Site 002
state: California
city: Murrieta
country: United States
facility: Forest Investigative Site 019
state: California
city: Oceanside
country: United States
facility: Forest Investigative Site 025
state: California
city: Orange
country: United States
facility: Forest Investigative Site 043
state: California
city: Redlands
country: United States
facility: Forest Investigative Site 003
state: California
city: Sherman Oaks
country: United States
facility: Forest Investigative Site 046
state: California
city: Upland
country: United States
facility: Forest Investigative Site 057
state: California
city: Cromwell
country: United States
facility: Forest Investigative Site 034
state: Connecticut
city: Fort Myers
country: United States
facility: Forest Investigative Site 038
state: Florida
city: Gainsville
country: United States
facility: Forest Investigative Site 018
state: Florida
city: Hallandale Beach
country: United States
facility: Forest Investigative Site 055
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 063
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 035
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 030
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 062
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site 045
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site 051
state: Florida
city: West Palm Beach
country: United States
facility: Forest Investigative Site 032
state: Florida
city: Winter Park
country: United States
facility: Forest Investigative Site 022
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 060
state: Georgia
city: Chicago
country: United States
facility: Forest Investigative Site 037
state: Illinois
city: Chicago
country: United States
facility: Forest Investigative Site 050
state: Illinois
city: Indianapolis
country: United States
facility: Forest Investigative Site 040
state: Indiana
city: Lafayette
country: United States
facility: Forest Investigative Site 012
state: Indiana
city: Prairie Village
country: United States
facility: Forest Investigative Site 053
state: Kansas
city: Baltimore
country: United States
facility: Forest Investigative Site 020
state: Maryland
city: Boston
country: United States
facility: Forest Investigative Site 031
state: Massachusetts
city: Las Vegas
country: United States
facility: Forest Investigative Site 061
state: Nevada
city: Willingboro
country: United States
facility: Forest Investigative Site 024
state: New Jersey
city: Albuquerque
country: United States
facility: Forest Investigative Site 010
state: New Mexico
city: Albuquerque
country: United States
facility: Forest Investigative Site 011
state: New Mexico
city: Brooklyn
country: United States
facility: Forest Investigative Site 004
state: New York
city: Cedarhurst
country: United States
facility: Forest Investigative Site 007
state: New York
city: New York City
country: United States
facility: Forest Investigative Site 058
state: New York
city: New York
country: United States
facility: Forest Investigative Site 047
state: New York
city: Cincinnati
country: United States
facility: Forest Investigative Site 039
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 042
state: Oklahoma
city: Oklahoma City
country: United States
facility: Forest Investigative Site 048
state: Oklahoma
city: Portland
country: United States
facility: Forest Investigative Site 066
state: Oregon
city: Allentown
country: United States
facility: Forest Investigative Site 014
state: Pennsylvania
city: Bridgeville
country: United States
facility: Forest Investigative Site 049
state: Pennsylvania
city: Memphis
country: United States
facility: Forest Investigative Site 064
state: Tennessee
city: Austin
country: United States
facility: Forest Investigative Site 013
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site 021
state: Texas
city: Bellevue
country: United States
facility: Forest Investigative Site 059
state: Washington
city: Seattle
country: United States
facility: Forest Investigative Site 065
state: Washington
city: Spokane
country: United States
facility: Forest Investigative Site 054
state: Washington
city: Middleton
country: United States
facility: Forest Investigative Site 052
state: Wisconsin
city: Milwaukee
country: United States
facility: Forest Investigative Site 056
state: Wisconsin
Study officials:
affiliation: Forest Laboratories
name: Carl Gommoll, MS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.