Clinical trial NCT01629966: Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder
Official title: A Double-blind, Placebo-Controlled Fixed-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder
GAD
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 680
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 is to evaluate the efficacy, safety and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (GAD)


Eligibility criteria: Inclusion Criteria:

* Male and female, 18 - 70 years of age
* Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder (GAD)
* Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)

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
* History of meeting DSM-IV-TR criteria for any of the following:

  * Any manic or 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 significant cognitive disorders
* Patients who are considered a suicide risk

Primary outcomes:
measure: Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site 001
state: Alabama
city: Beverly Hills
country: United States
facility: Forest Investigative Site 021
state: California
city: Glendale
country: United States
facility: Forest Investigative Site 023
state: California
city: Paramount
country: United States
facility: Forest Investigative Site 011
state: California
city: Norwich
country: United States
facility: Forest Investigative Site 026
state: Connecticut
city: Waterbury
country: United States
facility: Forest Investigative Site 027
state: Connecticut
city: Delray Beach
country: United States
facility: Forest Investigative Site 005
state: Florida
city: Oakland Park
country: United States
facility: Forest Investigative Site 014
state: Florida
city: South Miami
country: United States
facility: Forest Investigative Site 019
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 038
state: Georgia
city: Decatur
country: United States
facility: Forest Investigative Site 035
state: Georgia
city: Chicago
country: United States
facility: Forest Investigative Site 028
state: Illinois
city: Schaumburg
country: United States
facility: Forest Investigative Site 030
state: Illinois
city: Topeka
country: United States
facility: Forest Investigative Site 029
state: Kansas
city: Wichita
country: United States
facility: Forest Investigative Site 033
state: Kansas
city: Lake Charles
country: United States
facility: Forest Investigative Site 010
state: Louisiana
city: Baltimore
country: United States
facility: Forest Investigative Site 031
state: Maryland
city: Boston
country: United States
facility: Forest Investigative Site 025
state: Massachusetts
city: Saint Louis
country: United States
facility: Forest Investigative Site 037
state: Missouri
city: Las Vegas
country: United States
facility: Forest Investigative Site 015
state: Nevada
city: Berlin
country: United States
facility: Forest Investigative Site 016
state: New Jersey
city: Brooklyn
country: United States
facility: Forest Investigative Site 007
state: New York
city: New York
country: United States
facility: Forest Investigative Site 024
state: New York
city: New York
country: United States
facility: Forest Investigative Site 032
state: New York
city: New York
country: United States
facility: Forest Investigative Site 012
state: New York
city: Bismarck
country: United States
facility: Forest Investigative Site 020
state: North Dakota
city: Cincinnati
country: United States
facility: Forest Investigative Site 008
state: Ohio
city: Dayton
country: United States
facility: Forest Investigative Site 041
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 004
state: Oklahoma
city: Oklahoma City
country: United States
facility: Forest Investigative Site 034
state: Oklahoma
city: Portland
country: United States
facility: Forest Investigative Site 013
state: Oregon
city: Memphis
country: United States
facility: Forest Investigative Site 006
state: Tennessee
city: Wichita Falls
country: United States
facility: Forest Investigative Site 017
state: Texas
city: Salt Lake City
country: United States
facility: Forest Investigative Site 003
state: Utah
city: Charlottesville
country: United States
facility: Forest Investigative Site 018
state: Virginia
city: Bellevue
country: United States
facility: Forest Investigative Site 040
state: Washington
city: Seattle
country: United States
facility: Forest Investigative Site 039
state: Washington
Study officials:
affiliation: Forest Laboratories
name: Giovanna Forero, MA
role: STUDY_DIRECTOR
References:
citation: Khan A, Durgam S, Tang X, Ruth A, Mathews M, Gommoll CP. Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone. Prim Care Companion CNS Disord. 2016 Apr 28;18(2):10.4088/PCC.15m01904. doi: 10.4088/PCC.15m01904. eCollection 2016.
citation: Gommoll C, Durgam S, Mathews M, Forero G, Nunez R, Tang X, Thase ME. A double-blind, randomized, placebo-controlled, fixed-dose phase III study of vilazodone in patients with generalized anxiety disorder. Depress Anxiety. 2015 Jun;32(6):451-9. doi: 10.1002/da.22365. Epub 2015 Apr 17.