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

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo
Vilazadone
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Generalized Anxiety Disorder, GAD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Forest Investigative Site 022
  • Forest Investigative Site 023
  • Forest Investigative Site 010
  • Forest Investigative Site 025
  • Forest Investigative Site 004
  • Forest Investigative Site 007
  • Forest Investigative Site 016
  • Forest Investigative Site 012
  • Forest Investigative Site 017
  • Forest Investigative Site 028
  • Forest Investigative Site 002
  • Forest Investigative Site 020
  • Forest Investigative Site 024
  • Forest Investigative Site 001
  • Forest Investigative Site 026
  • Forest Investigative Site 029
  • Forest Investigative Site 019
  • Forest Investigative Site 003
  • Forest Investigative Site 031
  • Forest Investigative Site 021
  • Forest Investigative Site 030
  • Forest Investigative Site 005
  • Forest Investigative Site 014
  • Forest Investigative Site 015
  • Forest Investigative Site 027
  • Forest Investigative Site 006
  • Forest Investigative Site 008
  • Forest Investigative Site 018
  • Forest Investigative Site 011
  • Forest Investigative Site 013

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Vilazadone

Arm Description

Matching placebo tablets, oral administration

Vilazadone tablets, oral administration

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
January 9, 2013
Last Updated
December 4, 2019
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01766401
Brief Title
Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder
Acronym
VLZ-MD-06
Official Title
A Double-Blind, Placebo-Controlled, Flexible-Dose Study of Vilazadone in Patients With Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 31, 2013 (Actual)
Primary Completion Date
January 29, 2014 (Actual)
Study Completion Date
January 29, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Generalized Anxiety Disorder, GAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
402 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets, oral administration
Arm Title
Vilazadone
Arm Type
Experimental
Arm Description
Vilazadone tablets, oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Dose-matched placebo tablets, oral administration, once per day
Intervention Type
Drug
Intervention Name(s)
Vilazadone
Other Intervention Name(s)
Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.
Intervention Description
Viibryd
Primary Outcome Measure Information:
Title
Change in Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Description
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.
Time Frame
Baseline to Week 8
Secondary Outcome Measure Information:
Title
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
Description
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).
Time Frame
Baseline to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanna Forero, MA
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 022
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Forest Investigative Site 023
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Forest Investigative Site 010
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Forest Investigative Site 025
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Forest Investigative Site 004
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Forest Investigative Site 007
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Forest Investigative Site 016
City
Temecula
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Forest Investigative Site 012
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Forest Investigative Site 017
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Forest Investigative Site 028
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Forest Investigative Site 002
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Forest Investigative Site 020
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Forest Investigative Site 024
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Forest Investigative Site 001
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 026
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Forest Investigative Site 029
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Forest Investigative Site 019
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Forest Investigative Site 003
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Forest Investigative Site 031
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Forest Investigative Site 021
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Forest Investigative Site 030
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Forest Investigative Site 005
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Forest Investigative Site 014
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Forest Investigative Site 015
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Forest Investigative Site 027
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Forest Investigative Site 006
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site 008
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Forest Investigative Site 018
City
Houston
State/Province
Texas
ZIP/Postal Code
77096
Country
United States
Facility Name
Forest Investigative Site 011
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Forest Investigative Site 013
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27486544
Citation
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.
Results Reference
derived
PubMed Identifier
26291335
Citation
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.
Results Reference
derived

Learn more about this trial

Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder

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