Clinical trial NCT01844115: Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder
Official title: A Double-Blind, Placebo-Controlled, Flexible-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: 2013-05-01
Enrollment: 415
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 or female outpatient, 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
* Minimum score of 20 on Hamilton Rating Scale for Anxiety

Exclusion Criteria:

* Women who are pregnant or who will be breastfeeding during the study
* Patients with a history of:

  1. Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode
  2. Any depressive episode with psychotic or catatonic features
  3. Panic disorder with or without agoraphobia

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 023
state: Alabama
city: Phoenix
country: United States
facility: Forest Investigative Site 013
state: Arizona
city: Beverly Hills
country: United States
facility: Forest Investigative Site 036
state: California
city: Costa Mesa
country: United States
facility: Forest Investigative Site 001
state: California
city: Oceanside
country: United States
facility: Forest Investigative Site 009
state: California
city: Rancho Mirage
country: United States
facility: Forest Investigative Site 026
state: California
city: Sherman Oaks
country: United States
facility: Forest Investigative Site 017
state: California
city: Sherman Oaks
country: United States
facility: Forest Investigative Site 034
state: California
city: Bradenton
country: United States
facility: Forest Investigative Site 030
state: Florida
city: Gainesville
country: United States
facility: Forest Investigative Site 029
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 035
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 032
state: Florida
city: West Palm Beach
country: United States
facility: Forest Investigative Site 021
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 025
state: Georgia
city: Decatur
country: United States
facility: Forest Investigative Site 018
state: Georgia
city: Hoffman Estates
country: United States
facility: Forest Investigative Site 022
state: Illinois
city: Berlin
country: United States
facility: Forest Investigative Site 014
state: New Jersey
city: Cherry Hill
country: United States
facility: Forest Investigative Site 005
state: New Jersey
city: Albuquerque
country: United States
facility: Forest Investigative Site 015
state: New Mexico
city: Bronx
country: United States
facility: Forest Investigative Site 027
state: New York
city: Brooklyn
country: United States
facility: Forest Investigative Site 028
state: New York
city: Brooklyn
country: United States
facility: Forest Investigative Site 010
state: New York
city: Cedarhurst
country: United States
facility: Forest Investigative Site 002
state: New York
city: Mount Kisco
country: United States
facility: Forest Investigative Site 004
state: New York
city: New York
country: United States
facility: Forest Investigative Site 003
state: New York
city: New York
country: United States
facility: Forest Investigative Site 007
state: New York
city: New York
country: United States
facility: Forest Investigative Site 020
state: New York
city: Dayton
country: United States
facility: Forest Investigative Site 019
state: Ohio
city: Portland
country: United States
facility: Forest Investigative Site 008
state: Oregon
city: Allentown
country: United States
facility: Forest Investigative Site 037
state: Pennsylvania
city: Media
country: United States
facility: Forest Investigative Site 011
state: Pennsylvania
city: Memphis
country: United States
facility: Forest Investigative Site 033
state: Tennessee
city: Dallas
country: United States
facility: Forest Investigative Site 031
state: Texas
city: Herndon
country: United States
facility: Forest Investigative Site 012
state: Virginia
city: Bellevue
country: United States
facility: Forest Investigative Site 016
state: Washington
city: Seattle
country: United States
facility: Forest Investigative Site 024
state: Washington
Study officials:
affiliation: Forest Research Institute, a subsidiary of Actavis plc.
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: Durgam S, Gommoll C, Forero G, Nunez R, Tang X, Mathews M, Sheehan DV. Efficacy and Safety of Vilazodone in Patients With Generalized Anxiety Disorder: A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Trial. J Clin Psychiatry. 2016 Dec;77(12):1687-1694. doi: 10.4088/JCP.15m09885.