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

NCT ID: NCT01844115

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

415 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

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 tablets, oral administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vilazodone

Vilazodone tablets, oral administration

Group Type EXPERIMENTAL

Vilazodone

Intervention Type DRUG

Viibryd

Interventions

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Placebo

Intervention Type DRUG

Vilazodone

Viibryd

Intervention Type DRUG

Other Intervention Names

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Matching 10 mg and 20 mg placebo tablets, once-daily oral administration. Vilazodone, 20 mg once per day, oral administration, once daily or Vilazodone, 40 mg once daily, oral administration, once daily

Eligibility Criteria

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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
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 Research Institute, a subsidiary of Actavis plc.

Locations

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Forest Investigative Site 023

Birmingham, Alabama, United States

Site Status

Forest Investigative Site 013

Phoenix, Arizona, United States

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Forest Investigative Site 036

Beverly Hills, California, United States

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Forest Investigative Site 001

Costa Mesa, California, United States

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Forest Investigative Site 009

Oceanside, California, United States

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Forest Investigative Site 026

Rancho Mirage, California, United States

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Forest Investigative Site 017

Sherman Oaks, California, United States

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Forest Investigative Site 034

Sherman Oaks, California, United States

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Forest Investigative Site 030

Bradenton, Florida, United States

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Forest Investigative Site 029

Gainesville, Florida, United States

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Forest Investigative Site 035

Jacksonville, Florida, United States

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Forest Investigative Site 032

Orlando, Florida, United States

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Forest Investigative Site 021

West Palm Beach, Florida, United States

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Forest Investigative Site 025

Atlanta, Georgia, United States

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Forest Investigative Site 018

Decatur, Georgia, United States

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Forest Investigative Site 022

Hoffman Estates, Illinois, United States

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Forest Investigative Site 014

Berlin, New Jersey, United States

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Forest Investigative Site 005

Cherry Hill, New Jersey, United States

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Forest Investigative Site 015

Albuquerque, New Mexico, United States

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Forest Investigative Site 028

Brooklyn, New York, United States

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Forest Investigative Site 010

Brooklyn, New York, United States

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Forest Investigative Site 002

Cedarhurst, New York, United States

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Forest Investigative Site 004

Mount Kisco, New York, United States

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Forest Investigative Site 003

New York, New York, United States

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Forest Investigative Site 007

New York, New York, United States

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Forest Investigative Site 020

New York, New York, United States

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Forest Investigative Site 027

The Bronx, New York, United States

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Forest Investigative Site 019

Dayton, Ohio, United States

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Forest Investigative Site 008

Portland, Oregon, United States

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Forest Investigative Site 037

Allentown, Pennsylvania, United States

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Forest Investigative Site 011

Media, Pennsylvania, United States

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Forest Investigative Site 033

Memphis, Tennessee, United States

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Forest Investigative Site 031

Dallas, Texas, United States

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Forest Investigative Site 012

Herndon, Virginia, United States

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Forest Investigative Site 016

Bellevue, Washington, United States

Site Status

Forest Investigative Site 024

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)

Durgam S, Gommoll C, Forero G, Nunez R, Tang X, Mathews M, Sheehan DV. Efficacy and Safety of Vilazodone in Patients With Generalized Anxiety Disorder: A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Trial. J Clin Psychiatry. 2016 Dec;77(12):1687-1694. doi: 10.4088/JCP.15m09885.

Reference Type DERIVED
PMID: 27232052 (View on PubMed)

Other Identifiers

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VLZ-MD-07

Identifier Type: -

Identifier Source: org_study_id