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Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder

NCT ID: NCT01629966

Last Updated: 2019-12-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

680 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-03-31

Brief Summary

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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)

Detailed Description

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Conditions

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Generalized Anxiety Disorder

Keywords

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Generalized Anxiety Disorder GAD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Dose-matched placebo one per day, oral administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching 10 mg and 20 mg placebo tablets, once per day, oral administration,

Vilazadone 20mg

Vilazodone 20mg once per day, oral administration.

Group Type EXPERIMENTAL

Vilazodone

Intervention Type DRUG

Vilazodone, 20mg, oral administration once per day.

Vilazodone 40mg

Vilazodone 40mg once per day, oral administration

Group Type EXPERIMENTAL

Vilazodone

Intervention Type DRUG

Vilazodone, 40mg, oral administration once per day.

Interventions

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Placebo

Matching 10 mg and 20 mg placebo tablets, once per day, oral administration,

Intervention Type DRUG

Vilazodone

Vilazodone, 20mg, oral administration once per day.

Intervention Type DRUG

Vilazodone

Vilazodone, 40mg, oral administration once per day.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giovanna Forero, MA

Role: STUDY_DIRECTOR

Forest Laboratories

Locations

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Forest Investigative Site 001

Birmingham, Alabama, United States

Site Status

Forest Investigative Site 021

Beverly Hills, California, United States

Site Status

Forest Investigative Site 023

Glendale, California, United States

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Forest Investigative Site 011

Paramount, California, United States

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Forest Investigative Site 026

Norwich, Connecticut, United States

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Forest Investigative Site 027

Waterbury, Connecticut, United States

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Forest Investigative Site 005

Delray Beach, Florida, United States

Site Status

Forest Investigative Site 014

Oakland Park, Florida, United States

Site Status

Forest Investigative Site 019

South Miami, Florida, United States

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Forest Investigative Site 038

Atlanta, Georgia, United States

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Forest Investigative Site 035

Decatur, Georgia, United States

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Forest Investigative Site 028

Chicago, Illinois, United States

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Forest Investigative Site 030

Schaumburg, Illinois, United States

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Forest Investigative Site 029

Topeka, Kansas, United States

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Forest Investigative Site 033

Wichita, Kansas, United States

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Forest Investigative Site 010

Lake Charles, Louisiana, United States

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Forest Investigative Site 031

Baltimore, Maryland, United States

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Forest Investigative Site 025

Boston, Massachusetts, United States

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Forest Investigative Site 037

St Louis, Missouri, United States

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Forest Investigative Site 015

Las Vegas, Nevada, United States

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Forest Investigative Site 016

Berlin, New Jersey, United States

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Forest Investigative Site 007

Brooklyn, New York, United States

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Forest Investigative Site 024

New York, New York, United States

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Forest Investigative Site 032

New York, New York, United States

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Forest Investigative Site 012

New York, New York, United States

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Forest Investigative Site 020

Bismarck, North Dakota, United States

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Forest Investigative Site 008

Cincinnati, Ohio, United States

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Forest Investigative Site 041

Dayton, Ohio, United States

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Forest Investigative Site 004

Oklahoma City, Oklahoma, United States

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Forest Investigative Site 034

Oklahoma City, Oklahoma, United States

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Forest Investigative Site 013

Portland, Oregon, United States

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Forest Investigative Site 006

Memphis, Tennessee, United States

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Forest Investigative Site 017

Wichita Falls, Texas, United States

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Forest Investigative Site 003

Salt Lake City, Utah, United States

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Forest Investigative Site 018

Charlottesville, Virginia, United States

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Forest Investigative Site 040

Bellevue, Washington, United States

Site Status

Forest Investigative Site 039

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27486544 (View on PubMed)

Gommoll C, Durgam S, Mathews M, Forero G, Nunez R, Tang X, Thase ME. A double-blind, randomized, placebo-controlled, fixed-dose phase III study of vilazodone in patients with generalized anxiety disorder. Depress Anxiety. 2015 Jun;32(6):451-9. doi: 10.1002/da.22365. Epub 2015 Apr 17.

Reference Type DERIVED
PMID: 25891440 (View on PubMed)

Other Identifiers

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VLZ-MD-05

Identifier Type: -

Identifier Source: org_study_id