- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01629966
Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder (VLZ-MD-05)
December 4, 2019 updated by: Forest Laboratories
A Double-blind, Placebo-Controlled Fixed-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
680
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35216
- Forest Investigative Site 001
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California
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Beverly Hills, California, United States, 90210
- Forest Investigative Site 021
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Glendale, California, United States, 91204
- Forest Investigative Site 023
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Paramount, California, United States, 90723
- Forest Investigative Site 011
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Connecticut
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Norwich, Connecticut, United States, 06360
- Forest Investigative Site 026
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Waterbury, Connecticut, United States, 06708
- Forest Investigative Site 027
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Florida
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Delray Beach, Florida, United States, 33484
- Forest Investigative Site 005
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Oakland Park, Florida, United States, 33334
- Forest Investigative Site 014
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South Miami, Florida, United States, 33143
- Forest Investigative Site 019
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Georgia
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Atlanta, Georgia, United States, 30328
- Forest Investigative Site 038
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Decatur, Georgia, United States, 30030
- Forest Investigative Site 035
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Illinois
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Chicago, Illinois, United States, 60634
- Forest Investigative Site 028
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Schaumburg, Illinois, United States, 60194
- Forest Investigative Site 030
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Kansas
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Topeka, Kansas, United States, 66606
- Forest Investigative Site 029
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Wichita, Kansas, United States, 67207
- Forest Investigative Site 033
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Louisiana
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Lake Charles, Louisiana, United States, 70629
- Forest Investigative Site 010
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Maryland
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Baltimore, Maryland, United States, 21208
- Forest Investigative Site 031
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Forest Investigative Site 025
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Missouri
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Saint Louis, Missouri, United States, 63104
- Forest Investigative Site 037
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Nevada
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Las Vegas, Nevada, United States, 89103
- Forest Investigative Site 015
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New Jersey
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Berlin, New Jersey, United States, 08009
- Forest Investigative Site 016
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New York
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Brooklyn, New York, United States, 11235
- Forest Investigative Site 007
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New York, New York, United States, 10003
- Forest Investigative Site 024
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New York, New York, United States, 10023
- Forest Investigative Site 032
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New York, New York, United States, 10168
- Forest Investigative Site 012
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North Dakota
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Bismarck, North Dakota, United States, 58501
- Forest Investigative Site 020
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Ohio
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Cincinnati, Ohio, United States, 45215
- Forest Investigative Site 008
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Dayton, Ohio, United States, 45414
- Forest Investigative Site 041
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- Forest Investigative Site 004
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Oklahoma City, Oklahoma, United States, 73116
- Forest Investigative Site 034
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Oregon
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Portland, Oregon, United States, 97210
- Forest Investigative Site 013
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Tennessee
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Memphis, Tennessee, United States, 38119
- Forest Investigative Site 006
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Texas
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Wichita Falls, Texas, United States, 76309
- Forest Investigative Site 017
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Utah
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Salt Lake City, Utah, United States, 84106
- Forest Investigative Site 003
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Virginia
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Charlottesville, Virginia, United States, 22911
- Forest Investigative Site 018
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Washington
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Bellevue, Washington, United States, 98007
- Forest Investigative Site 040
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Seattle, Washington, United States, 98104
- Forest Investigative Site 039
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Dose-matched placebo one per day, oral administration
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Matching 10 mg and 20 mg placebo tablets, once per day, oral administration,
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EXPERIMENTAL: Vilazadone 20mg
Vilazodone 20mg once per day, oral administration.
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Vilazodone, 20mg, oral administration once per day.
Vilazodone, 40mg, oral administration once per day.
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EXPERIMENTAL: Vilazodone 40mg
Vilazodone 40mg once per day, oral administration
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Vilazodone, 20mg, oral administration once per day.
Vilazodone, 40mg, oral administration once per day.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Time Frame: Baseline to Week 8
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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.
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Baseline to Week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
Time Frame: Baseline to Week 8
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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).
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Baseline to Week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 30, 2012
Primary Completion (ACTUAL)
February 28, 2014
Study Completion (ACTUAL)
March 31, 2014
Study Registration Dates
First Submitted
June 26, 2012
First Submitted That Met QC Criteria
June 27, 2012
First Posted (ESTIMATE)
June 28, 2012
Study Record Updates
Last Update Posted (ACTUAL)
December 18, 2019
Last Update Submitted That Met QC Criteria
December 4, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Disease
- Anxiety Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Vilazodone Hydrochloride
Other Study ID Numbers
- VLZ-MD-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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