Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder (VLZ-MD-06)

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: NCT01766401
Recruitment Status : Completed
First Posted : January 11, 2013
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: Vilazadone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Flexible-Dose Study of Vilazadone in Patients With Generalized Anxiety Disorder
Study Start Date : January 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Matching placebo tablets, oral administration
Drug: Placebo
Other Name: Dose-matched placebo tablets, oral administration, once per day
Experimental: Vilazadone
Vilazadone tablets, oral administration
Drug: Vilazadone
Other Name: Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.

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, 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

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): NCT01766401

  Show 30 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: NCT01766401     History of Changes
Other Study ID Numbers: VLZ-MD-06
First Posted: January 11, 2013    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