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

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo
Vilazodone
Vilazodone
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

  • History of meeting DSM-IV-TR criteria for any of the following:

    • 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

Sites / Locations

  • Forest Investigative Site 001
  • Forest Investigative Site 021
  • Forest Investigative Site 023
  • Forest Investigative Site 011
  • Forest Investigative Site 026
  • Forest Investigative Site 027
  • Forest Investigative Site 005
  • Forest Investigative Site 014
  • Forest Investigative Site 019
  • Forest Investigative Site 038
  • Forest Investigative Site 035
  • Forest Investigative Site 028
  • Forest Investigative Site 030
  • Forest Investigative Site 029
  • Forest Investigative Site 033
  • Forest Investigative Site 010
  • Forest Investigative Site 031
  • Forest Investigative Site 025
  • Forest Investigative Site 037
  • Forest Investigative Site 015
  • Forest Investigative Site 016
  • Forest Investigative Site 007
  • Forest Investigative Site 024
  • Forest Investigative Site 032
  • Forest Investigative Site 012
  • Forest Investigative Site 020
  • Forest Investigative Site 008
  • Forest Investigative Site 041
  • Forest Investigative Site 004
  • Forest Investigative Site 034
  • Forest Investigative Site 013
  • Forest Investigative Site 006
  • Forest Investigative Site 017
  • Forest Investigative Site 003
  • Forest Investigative Site 018
  • Forest Investigative Site 040
  • Forest Investigative Site 039

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Vilazadone 20mg

Vilazodone 40mg

Arm Description

Dose-matched placebo one per day, oral administration

Vilazodone 20mg once per day, oral administration.

Vilazodone 40mg once per day, oral administration

Outcomes

Primary Outcome Measures

Change From 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
June 26, 2012
Last Updated
December 4, 2019
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01629966
Brief Title
Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder
Acronym
VLZ-MD-05
Official Title
A Double-blind, Placebo-Controlled Fixed-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 30, 2012 (Actual)
Primary Completion Date
February 28, 2014 (Actual)
Study Completion Date
March 31, 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
680 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dose-matched placebo one per day, oral administration
Arm Title
Vilazadone 20mg
Arm Type
Experimental
Arm Description
Vilazodone 20mg once per day, oral administration.
Arm Title
Vilazodone 40mg
Arm Type
Experimental
Arm Description
Vilazodone 40mg once per day, oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching 10 mg and 20 mg placebo tablets, once per day, oral administration,
Intervention Type
Drug
Intervention Name(s)
Vilazodone
Intervention Description
Vilazodone, 20mg, oral administration once per day.
Intervention Type
Drug
Intervention Name(s)
Vilazodone
Intervention Description
Vilazodone, 40mg, oral administration once per day.
Primary Outcome Measure Information:
Title
Change From 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 History of meeting DSM-IV-TR criteria for any of the following: 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
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 001
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Forest Investigative Site 021
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Forest Investigative Site 023
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Forest Investigative Site 011
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Forest Investigative Site 026
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Forest Investigative Site 027
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Forest Investigative Site 005
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Forest Investigative Site 014
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Forest Investigative Site 019
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Forest Investigative Site 038
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Forest Investigative Site 035
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Forest Investigative Site 028
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Forest Investigative Site 030
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Facility Name
Forest Investigative Site 029
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Forest Investigative Site 033
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Forest Investigative Site 010
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
Forest Investigative Site 031
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Forest Investigative Site 025
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Forest Investigative Site 037
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Forest Investigative Site 015
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89103
Country
United States
Facility Name
Forest Investigative Site 016
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Forest Investigative Site 007
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Forest Investigative Site 024
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Forest Investigative Site 032
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
Forest Investigative Site 012
City
New York
State/Province
New York
ZIP/Postal Code
10168
Country
United States
Facility Name
Forest Investigative Site 020
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Forest Investigative Site 008
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
Forest Investigative Site 041
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Forest Investigative Site 004
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Forest Investigative Site 034
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Forest Investigative Site 013
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
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 017
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Forest Investigative Site 003
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Forest Investigative Site 018
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Forest Investigative Site 040
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Forest Investigative Site 039
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
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
25891440
Citation
Gommoll C, Durgam S, Mathews M, Forero G, Nunez R, Tang X, Thase ME. A double-blind, randomized, placebo-controlled, fixed-dose phase III study of vilazodone in patients with generalized anxiety disorder. Depress Anxiety. 2015 Jun;32(6):451-9. doi: 10.1002/da.22365. Epub 2015 Apr 17.
Results Reference
derived

Learn more about this trial

Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder

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