Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder

NCT01629966 | Completed Phase 3 Results

• 1 other identifier: VLZ-MD-05
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 37

Brief 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)

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder; GAD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in the Sheehan Disability Scale (SDS) Total Score

  Baseline to Week 8

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Dose-matched placebo one per day, oral administration

Drug: Placebo

Vilazadone 20mg

EXPERIMENTAL

Vilazodone 20mg once per day, oral administration.

Drug: Vilazodone

Vilazodone 40mg

EXPERIMENTAL

Vilazodone 40mg once per day, oral administration

Drug: Vilazodone

Interventions

Placebo DRUG

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

Placebo

Vilazodone DRUG

Vilazodone, 20mg, oral administration once per day.

Vilazadone 20mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (37)

Forest Investigative Site 001

Birmingham, Alabama, 35216, United States

Location

Forest Investigative Site 021

Beverly Hills, California, 90210, United States

Location

Forest Investigative Site 023

Glendale, California, 91204, United States

Location

Forest Investigative Site 011

Paramount, California, 90723, United States

Location

Forest Investigative Site 026

Norwich, Connecticut, 06360, United States

Location

Forest Investigative Site 027

Waterbury, Connecticut, 06708, United States

Location

Forest Investigative Site 005

Delray Beach, Florida, 33484, United States

Location

Forest Investigative Site 014

Oakland Park, Florida, 33334, United States

Location

Forest Investigative Site 019

South Miami, Florida, 33143, United States

Location

Forest Investigative Site 038

Atlanta, Georgia, 30328, United States

Location

Forest Investigative Site 035

Decatur, Georgia, 30030, United States

Location

Forest Investigative Site 028

Chicago, Illinois, 60634, United States

Location

Forest Investigative Site 030

Schaumburg, Illinois, 60194, United States

Location

Forest Investigative Site 029

Topeka, Kansas, 66606, United States

Location

Forest Investigative Site 033

Wichita, Kansas, 67207, United States

Location

Forest Investigative Site 010

Lake Charles, Louisiana, 70629, United States

Location

Forest Investigative Site 031

Baltimore, Maryland, 21208, United States

Location

Forest Investigative Site 025

Boston, Massachusetts, 02114, United States

Location

Forest Investigative Site 037

St Louis, Missouri, 63104, United States

Location

Forest Investigative Site 015

Las Vegas, Nevada, 89103, United States

Location

Forest Investigative Site 016

Berlin, New Jersey, 08009, United States

Location

Forest Investigative Site 007

Brooklyn, New York, 11235, United States

Location

Forest Investigative Site 024

New York, New York, 10003, United States

Location

Forest Investigative Site 032

New York, New York, 10023, United States

Location

Forest Investigative Site 012

New York, New York, 10168, United States

Location

Forest Investigative Site 020

Bismarck, North Dakota, 58501, United States

Location

Forest Investigative Site 008

Cincinnati, Ohio, 45215, United States

Location

Forest Investigative Site 041

Dayton, Ohio, 45414, United States

Location

Forest Investigative Site 004

Oklahoma City, Oklahoma, 73112, United States

Location

Forest Investigative Site 034

Oklahoma City, Oklahoma, 73116, United States

Location

Forest Investigative Site 013

Portland, Oregon, 97210, United States

Location

Forest Investigative Site 006

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site 017

Wichita Falls, Texas, 76309, United States

Location

Forest Investigative Site 003

Salt Lake City, Utah, 84106, United States

Location

Forest Investigative Site 018

Charlottesville, Virginia, 22911, United States

Location

Forest Investigative Site 040

Bellevue, Washington, 98007, United States

Location

Forest Investigative Site 039

Seattle, Washington, 98104, United States

Location

Related Publications (2)

• 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.

  PMID: 27486544 DERIVED

• 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.

  PMID: 25891440 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Vilazodone Hydrochloride

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Forest Research Institute, Inc

IR-CTRegistration@allergan.com

877-277-8566

Study Officials

• Giovanna Forero, MA

  Forest Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: June 30, 2012
• Primary Completion: February 28, 2014
• Study Completion: March 31, 2014
• Last Updated: December 18, 2019
• Results First Posted: December 18, 2019

Record last verified: 2019-11

Locations

US (37)