Clinical trial NCT01766401: Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder
Official title: A Double-Blind, Placebo-Controlled, Flexible-Dose Study of Vilazadone 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: 2013-01-11
Enrollment: 402
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
* 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 in 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: Arcadia
country: United States
facility: Forest Investigative Site 022
state: California
city: Beverly Hills
country: United States
facility: Forest Investigative Site 023
state: California
city: Encino
country: United States
facility: Forest Investigative Site 010
state: California
city: Newport Beach
country: United States
facility: Forest Investigative Site 025
state: California
city: Redlands
country: United States
facility: Forest Investigative Site 004
state: California
city: Sherman Oaks
country: United States
facility: Forest Investigative Site 007
state: California
city: Temecula
country: United States
facility: Forest Investigative Site 016
state: California
city: Upland
country: United States
facility: Forest Investigative Site 012
state: California
city: Coral Springs
country: United States
facility: Forest Investigative Site 017
state: Florida
city: Fort Myers
country: United States
facility: Forest Investigative Site 028
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 002
state: Florida
city: Leesburg
country: United States
facility: Forest Investigative Site 020
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 024
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 001
state: Florida
city: Indianapolis
country: United States
facility: Forest Investigative Site 026
state: Indiana
city: Shreveport
country: United States
facility: Forest Investigative Site 029
state: Louisiana
city: Las Vegas
country: United States
facility: Forest Investigative Site 019
state: Nevada
city: Canton
country: United States
facility: Forest Investigative Site 003
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site 031
state: Ohio
city: Mason
country: United States
facility: Forest Investigative Site 021
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 030
state: Oklahoma
city: Salem
country: United States
facility: Forest Investigative Site 005
state: Oregon
city: Allentown
country: United States
facility: Forest Investigative Site 014
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site 015
state: Pennsylvania
city: Lincoln
country: United States
facility: Forest Investigative Site 027
state: Rhode Island
city: Memphis
country: United States
facility: Forest Investigative Site 006
state: Tennessee
city: Houston
country: United States
facility: Forest Investigative Site 008
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 018
state: Texas
city: Murray
country: United States
facility: Forest Investigative Site 011
state: Utah
city: Woodstock
country: United States
facility: Forest Investigative Site 013
state: Vermont
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, Forero G, Mathews M, Nunez R, Tang X, Durgam S, Sambunaris A. Vilazodone in patients with generalized anxiety disorder: a double-blind, randomized, placebo-controlled, flexible-dose study. Int Clin Psychopharmacol. 2015 Nov;30(6):297-306. doi: 10.1097/YIC.0000000000000096.