Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

— VLZ-MD-06  

Official title:

A Double-Blind, Placebo-Controlled, Flexible-Dose Study of Vilazadone in Patients With Generalized Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766401
• Other study ID #: VLZ-MD-06
• Status: Completed
• Phase: Phase 3
• Start date: January 31, 2013
• Est. completion date: January 29, 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: 402
• Est. completion date: January 29, 2014
• Est. primary completion date: January 29, 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

• 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder

Intervention

Drug:
• Placebo

• Vilazadone
Viibryd

Locations

Country	Name	City	State
United States	Forest Investigative Site 014	Allentown	Pennsylvania
United States	Forest Investigative Site 022	Arcadia	California
United States	Forest Investigative Site 023	Beverly Hills	California
United States	Forest Investigative Site 003	Canton	Ohio
United States	Forest Investigative Site 031	Columbus	Ohio
United States	Forest Investigative Site 017	Coral Springs	Florida
United States	Forest Investigative Site 010	Encino	California
United States	Forest Investigative Site 028	Fort Myers	Florida
United States	Forest Investigative Site 008	Houston	Texas
United States	Forest Investigative Site 018	Houston	Texas
United States	Forest Investigative Site 026	Indianapolis	Indiana
United States	Forest Investigative Site 002	Jacksonville	Florida
United States	Forest Investigative Site 019	Las Vegas	Nevada
United States	Forest Investigative Site 020	Leesburg	Florida
United States	Forest Investigative Site 027	Lincoln	Rhode Island
United States	Forest Investigative Site 021	Mason	Ohio
United States	Forest Investigative Site 006	Memphis	Tennessee
United States	Forest Investigative Site 024	Miami	Florida
United States	Forest Investigative Site 011	Murray	Utah
United States	Forest Investigative Site 025	Newport Beach	California
United States	Forest Investigative Site 030	Oklahoma City	Oklahoma
United States	Forest Investigative Site 001	Orlando	Florida
United States	Forest Investigative Site 015	Philadelphia	Pennsylvania
United States	Forest Investigative Site 004	Redlands	California
United States	Forest Investigative Site 005	Salem	Oregon
United States	Forest Investigative Site 007	Sherman Oaks	California
United States	Forest Investigative Site 029	Shreveport	Louisiana
United States	Forest Investigative Site 016	Temecula	California
United States	Forest Investigative Site 012	Upland	California
United States	Forest Investigative Site 013	Woodstock	Vermont

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 in 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