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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01629966
First received: June 26, 2012
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Generalized Anxiety Disorder
Drug: Placebo
Drug: Vilazodone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-Controlled Fixed-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Hamilton Rating Scale for Anxiety (HAM-A) total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sheehan Disability Scale (SDS) total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 680
Study Start Date: June 2012
Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629966

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

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01629966     History of Changes
Other Study ID Numbers: VLZ-MD-05
Study First Received: June 26, 2012
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Generalized Anxiety Disorder
GAD

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 23, 2014