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

A Double-Blind, Placebo-Controlled, Flexible-Dose Study of Vilazadone 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: Generalized Anxiety Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Vilazadone

• Study Type: Interventional
• Enrollment (Actual): 402
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Arcadia, California, United States, 91007
      • Forest Investigative Site 022
    • Beverly Hills, California, United States, 90210
      • Forest Investigative Site 023
    • Encino, California, United States, 91316
      • Forest Investigative Site 010
    • Newport Beach, California, United States, 92660
      • Forest Investigative Site 025
    • Redlands, California, United States, 92374
      • Forest Investigative Site 004
    • Sherman Oaks, California, United States, 91403
      • Forest Investigative Site 007
    • Temecula, California, United States, 92562
      • Forest Investigative Site 016
    • Upland, California, United States, 91786
      • Forest Investigative Site 012
  • Florida
    • Coral Springs, Florida, United States, 33067
      • Forest Investigative Site 017
    • Fort Myers, Florida, United States, 33912
      • Forest Investigative Site 028
    • Jacksonville, Florida, United States, 32256
      • Forest Investigative Site 002
    • Leesburg, Florida, United States, 34748
      • Forest Investigative Site 020
    • Miami, Florida, United States, 33015
      • Forest Investigative Site 024
    • Orlando, Florida, United States, 32806
      • Forest Investigative Site 001
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Forest Investigative Site 026
  • Louisiana
    • Shreveport, Louisiana, United States, 71104
      • Forest Investigative Site 029
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Forest Investigative Site 019
  • Ohio
    • Canton, Ohio, United States, 44718
      • Forest Investigative Site 003
    • Columbus, Ohio, United States, 43210
      • Forest Investigative Site 031
    • Mason, Ohio, United States, 45040
      • Forest Investigative Site 021
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Forest Investigative Site 030
  • Oregon
    • Salem, Oregon, United States, 97301
      • Forest Investigative Site 005
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Forest Investigative Site 014
    • Philadelphia, Pennsylvania, United States, 19139
      • Forest Investigative Site 015
  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • Forest Investigative Site 027
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Forest Investigative Site 006
  • Texas
    • Houston, Texas, United States, 77054
      • Forest Investigative Site 008
    • Houston, Texas, United States, 77096
      • Forest Investigative Site 018
  • Utah
    • Murray, Utah, United States, 84123
      • Forest Investigative Site 011
  • Vermont
    • Woodstock, Vermont, United States, 05091
      • Forest Investigative Site 013

Participation Criteria

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

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Matching placebo tablets, oral administration	Drug: Placebo; Other Names: Dose-matched placebo tablets, oral administration, once per day
EXPERIMENTAL: Vilazadone; Vilazadone tablets, oral administration	Drug: Vilazadone; Viibryd; Other Names: Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score	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).	Baseline to Week 8

Collaborators and Investigators

• Sponsor: Forest Laboratories

Publications and helpful links

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, Forero G, Mathews M, Nunez R, Tang X, Durgam S, Sambunaris A. Vilazodone in patients with generalized anxiety disorder: a double-blind, randomized, placebo-controlled, flexible-dose study. Int Clin Psychopharmacol. 2015 Nov;30(6):297-306. doi: 10.1097/YIC.0000000000000096.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2013
• Primary Completion (ACTUAL): January 29, 2014
• Study Completion (ACTUAL): January 29, 2014

Study Registration Dates

• First Submitted: January 9, 2013
• First Submitted That Met QC Criteria: January 10, 2013
• First Posted (ESTIMATE): January 11, 2013

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: Generalized Anxiety Disorder; GAD
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Anxiety Disorders
• Other Study ID Numbers: VLZ-MD-06