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NCT01844115 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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