Clinical trial NCT01473394: Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder
Official title: A Double-blind, Placebo-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: 518
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 further characterize the efficacy, safety, and tolerability of a single fixed dose level 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 8
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8
timeFrame: Baseline to Week 8
measure: Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Forest Investigative Site 009
state: California
city: Encino
country: United States
facility: Forest Investigative Site 003
state: California
city: New port Beach
country: United States
facility: Forest Investigative Site 010
state: California
city: Jacksonville
country: United States
facility: Forest Investigative Site 005
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 004
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 012
state: Georgia
city: Baltimore
country: United States
facility: Forest Investigative Site 001
state: Maryland
city: Dayton
country: United States
facility: Forest Investigative Site 002
state: Ohio
city: Philadelphia
country: United States
facility: Forest Investigative Site 011
state: Pennsylvania
city: Lincoln
country: United States
facility: Forest Investigative Site 015
state: Rhode Island
city: Memphis
country: United States
facility: Forest Investigative Site 008
state: Tennessee
city: San Antonio
country: United States
facility: Forest Investigative Site 016
state: Texas
city: Bellevue
country: United States
facility: Forest Investigative Site 006
state: Washington
city: Seattle
country: United States
facility: Forest Investigative Site 013
state: Washington
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: 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.
citation: 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.