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

NCT ID: NCT01766401

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

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-01-29

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

Matching placebo tablets, oral administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vilazadone

Vilazadone tablets, oral administration

Group Type EXPERIMENTAL

Vilazadone

Intervention Type DRUG

Viibryd

Interventions

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Placebo

Intervention Type DRUG

Vilazadone

Viibryd

Intervention Type DRUG

Other Intervention Names

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Dose-matched placebo tablets, oral administration, once per day Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.

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
* 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
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 022

Arcadia, California, United States

Site Status

Forest Investigative Site 023

Beverly Hills, California, United States

Site Status

Forest Investigative Site 010

Encino, California, United States

Site Status

Forest Investigative Site 025

Newport Beach, California, United States

Site Status

Forest Investigative Site 004

Redlands, California, United States

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Forest Investigative Site 007

Sherman Oaks, California, United States

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Forest Investigative Site 016

Temecula, California, United States

Site Status

Forest Investigative Site 012

Upland, California, United States

Site Status

Forest Investigative Site 017

Coral Springs, Florida, United States

Site Status

Forest Investigative Site 028

Fort Myers, Florida, United States

Site Status

Forest Investigative Site 002

Jacksonville, Florida, United States

Site Status

Forest Investigative Site 020

Leesburg, Florida, United States

Site Status

Forest Investigative Site 024

Miami, Florida, United States

Site Status

Forest Investigative Site 001

Orlando, Florida, United States

Site Status

Forest Investigative Site 026

Indianapolis, Indiana, United States

Site Status

Forest Investigative Site 029

Shreveport, Louisiana, United States

Site Status

Forest Investigative Site 019

Las Vegas, Nevada, United States

Site Status

Forest Investigative Site 003

Canton, Ohio, United States

Site Status

Forest Investigative Site 031

Columbus, Ohio, United States

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Forest Investigative Site 021

Mason, Ohio, United States

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Forest Investigative Site 030

Oklahoma City, Oklahoma, United States

Site Status

Forest Investigative Site 005

Salem, Oregon, United States

Site Status

Forest Investigative Site 014

Allentown, Pennsylvania, United States

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Forest Investigative Site 015

Philadelphia, Pennsylvania, United States

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Forest Investigative Site 027

Lincoln, Rhode Island, United States

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Forest Investigative Site 006

Memphis, Tennessee, United States

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Forest Investigative Site 008

Houston, Texas, United States

Site Status

Forest Investigative Site 018

Houston, Texas, United States

Site Status

Forest Investigative Site 011

Murray, Utah, United States

Site Status

Forest Investigative Site 013

Woodstock, Vermont, 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, Forero G, Mathews M, Nunez R, Tang X, Durgam S, Sambunaris A. Vilazodone in patients with generalized anxiety disorder: a double-blind, randomized, placebo-controlled, flexible-dose study. Int Clin Psychopharmacol. 2015 Nov;30(6):297-306. doi: 10.1097/YIC.0000000000000096.

Reference Type DERIVED
PMID: 26291335 (View on PubMed)

Other Identifiers

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VLZ-MD-06

Identifier Type: -

Identifier Source: org_study_id