Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder (VLZ-MD-05)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01629966
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):
Forest Laboratories

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)

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Drug: Placebo Drug: Vilazodone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-Controlled Fixed-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.
Study Start Date : June 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Dose-matched placebo one per day, oral administration
Drug: Placebo
Matching 10 mg and 20 mg placebo tablets, once per day, oral administration,
Experimental: Vilazadone 20mg
Vilazodone 20mg once per day, oral administration.
Drug: Vilazodone
Vilazodone, 20mg, oral administration once per day.
Experimental: Vilazodone 40mg
Vilazodone 40mg once per day, oral administration
Drug: Vilazodone
Vilazodone, 40mg, oral administration once per day.

Primary Outcome Measures :
  1. Hamilton Rating Scale for Anxiety (HAM-A) total score [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Sheehan Disability Scale (SDS) total score [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01629966

  Show 37 Study Locations
Sponsors and Collaborators
Forest Laboratories
Study Director: Giovanna Forero, MA Forest Laboratories

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Forest Laboratories Identifier: NCT01629966     History of Changes
Other Study ID Numbers: VLZ-MD-05
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: February 2015

Keywords provided by Forest Laboratories:
Generalized Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Pathologic Processes
Mental Disorders
Vilazodone Hydrochloride
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists