Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844115
• Other study ID #: VLZ-MD-07
• Status: Completed
• Phase: Phase 3
• Start date: April 30, 2013
• 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: 415
• Est. completion date: March 31, 2014
• Est. primary completion date: March 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder

Intervention

Drug:
• Placebo

• Vilazodone
Viibryd

Locations

Country	Name	City	State
United States	Forest Investigative Site 015	Albuquerque	New Mexico
United States	Forest Investigative Site 037	Allentown	Pennsylvania
United States	Forest Investigative Site 025	Atlanta	Georgia
United States	Forest Investigative Site 016	Bellevue	Washington
United States	Forest Investigative Site 014	Berlin	New Jersey
United States	Forest Investigative Site 036	Beverly Hills	California
United States	Forest Investigative Site 023	Birmingham	Alabama
United States	Forest Investigative Site 030	Bradenton	Florida
United States	Forest Investigative Site 027	Bronx	New York
United States	Forest Investigative Site 010	Brooklyn	New York
United States	Forest Investigative Site 028	Brooklyn	New York
United States	Forest Investigative Site 002	Cedarhurst	New York
United States	Forest Investigative Site 005	Cherry Hill	New Jersey
United States	Forest Investigative Site 001	Costa Mesa	California
United States	Forest Investigative Site 031	Dallas	Texas
United States	Forest Investigative Site 019	Dayton	Ohio
United States	Forest Investigative Site 018	Decatur	Georgia
United States	Forest Investigative Site 029	Gainesville	Florida
United States	Forest Investigative Site 012	Herndon	Virginia
United States	Forest Investigative Site 022	Hoffman Estates	Illinois
United States	Forest Investigative Site 035	Jacksonville	Florida
United States	Forest Investigative Site 011	Media	Pennsylvania
United States	Forest Investigative Site 033	Memphis	Tennessee
United States	Forest Investigative Site 004	Mount Kisco	New York
United States	Forest Investigative Site 003	New York	New York
United States	Forest Investigative Site 007	New York	New York
United States	Forest Investigative Site 020	New York	New York
United States	Forest Investigative Site 009	Oceanside	California
United States	Forest Investigative Site 032	Orlando	Florida
United States	Forest Investigative Site 013	Phoenix	Arizona
United States	Forest Investigative Site 008	Portland	Oregon
United States	Forest Investigative Site 026	Rancho Mirage	California
United States	Forest Investigative Site 024	Seattle	Washington
United States	Forest Investigative Site 017	Sherman Oaks	California
United States	Forest Investigative Site 034	Sherman Oaks	California
United States	Forest Investigative Site 021	West Palm Beach	Florida

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