Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

— VLZ-MD-05  

Official title:

A Double-blind, Placebo-Controlled Fixed-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629966
• Other study ID #: VLZ-MD-05
• Status: Completed
• Phase: Phase 3
• Start date: June 30, 2012
• Est. completion date: March 31, 2014

Study information

• Verified date: November 2019
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: March 31, 2014
• Est. primary completion date: February 28, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder

Intervention

Drug:
• Placebo
Matching 10 mg and 20 mg placebo tablets, once per day, oral administration,
• Vilazodone
Vilazodone, 20mg, oral administration once per day.
• Vilazodone
Vilazodone, 40mg, oral administration once per day.

Locations

Country	Name	City	State
United States	Forest Investigative Site 038	Atlanta	Georgia
United States	Forest Investigative Site 031	Baltimore	Maryland
United States	Forest Investigative Site 040	Bellevue	Washington
United States	Forest Investigative Site 016	Berlin	New Jersey
United States	Forest Investigative Site 021	Beverly Hills	California
United States	Forest Investigative Site 001	Birmingham	Alabama
United States	Forest Investigative Site 020	Bismarck	North Dakota
United States	Forest Investigative Site 025	Boston	Massachusetts
United States	Forest Investigative Site 007	Brooklyn	New York
United States	Forest Investigative Site 018	Charlottesville	Virginia
United States	Forest Investigative Site 028	Chicago	Illinois
United States	Forest Investigative Site 008	Cincinnati	Ohio
United States	Forest Investigative Site 041	Dayton	Ohio
United States	Forest Investigative Site 035	Decatur	Georgia
United States	Forest Investigative Site 005	Delray Beach	Florida
United States	Forest Investigative Site 023	Glendale	California
United States	Forest Investigative Site 010	Lake Charles	Louisiana
United States	Forest Investigative Site 015	Las Vegas	Nevada
United States	Forest Investigative Site 006	Memphis	Tennessee
United States	Forest Investigative Site 012	New York	New York
United States	Forest Investigative Site 024	New York	New York
United States	Forest Investigative Site 032	New York	New York
United States	Forest Investigative Site 026	Norwich	Connecticut
United States	Forest Investigative Site 014	Oakland Park	Florida
United States	Forest Investigative Site 004	Oklahoma City	Oklahoma
United States	Forest Investigative Site 034	Oklahoma City	Oklahoma
United States	Forest Investigative Site 011	Paramount	California
United States	Forest Investigative Site 013	Portland	Oregon
United States	Forest Investigative Site 037	Saint Louis	Missouri
United States	Forest Investigative Site 003	Salt Lake City	Utah
United States	Forest Investigative Site 030	Schaumburg	Illinois
United States	Forest Investigative Site 039	Seattle	Washington
United States	Forest Investigative Site 019	South Miami	Florida
United States	Forest Investigative Site 029	Topeka	Kansas
United States	Forest Investigative Site 027	Waterbury	Connecticut
United States	Forest Investigative Site 033	Wichita	Kansas
United States	Forest Investigative Site 017	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.	Baseline to Week 8
Secondary	Change From Baseline in the Sheehan Disability Scale (SDS) Total Score	The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe).	Baseline to Week 8