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Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo
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 or female outpatient, 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
  • Minimum score of 20 on Hamilton Rating Scale for Anxiety

Exclusion Criteria:

  • Women who are pregnant or who will be breastfeeding during the study

  • Patients with a history of:

    1. Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode
    2. Any depressive episode with psychotic or catatonic features
    3. Panic disorder with or without agoraphobia

Sites / Locations

  • Forest Investigative Site 023
  • Forest Investigative Site 013
  • Forest Investigative Site 036
  • Forest Investigative Site 001
  • Forest Investigative Site 009
  • Forest Investigative Site 026
  • Forest Investigative Site 017
  • Forest Investigative Site 034
  • Forest Investigative Site 030
  • Forest Investigative Site 029
  • Forest Investigative Site 035
  • Forest Investigative Site 032
  • Forest Investigative Site 021
  • Forest Investigative Site 025
  • Forest Investigative Site 018
  • Forest Investigative Site 022
  • Forest Investigative Site 014
  • Forest Investigative Site 005
  • Forest Investigative Site 015
  • Forest Investigative Site 027
  • Forest Investigative Site 028
  • Forest Investigative Site 010
  • Forest Investigative Site 002
  • Forest Investigative Site 004
  • Forest Investigative Site 003
  • Forest Investigative Site 007
  • Forest Investigative Site 020
  • Forest Investigative Site 019
  • Forest Investigative Site 008
  • Forest Investigative Site 037
  • Forest Investigative Site 011
  • Forest Investigative Site 033
  • Forest Investigative Site 031
  • Forest Investigative Site 012
  • Forest Investigative Site 016
  • Forest Investigative Site 024

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Vilazodone

Arm Description

Dose-matched placebo tablets, oral administration

Vilazodone tablets, 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
April 27, 2013
Last Updated
December 4, 2019
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01844115
Brief Title
Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder
Official Title
A Double-Blind, Placebo-Controlled, Flexible-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
April 30, 2013 (Actual)
Primary Completion Date
March 31, 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
415 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dose-matched placebo tablets, oral administration
Arm Title
Vilazodone
Arm Type
Experimental
Arm Description
Vilazodone tablets, oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching 10 mg and 20 mg placebo tablets, once-daily oral administration.
Intervention Type
Drug
Intervention Name(s)
Vilazodone
Other Intervention Name(s)
Vilazodone, 20 mg once per day, oral administration, once daily or Vilazodone, 40 mg once daily, oral administration, once daily
Intervention Description
Viibryd
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 or female outpatient, 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 Minimum score of 20 on Hamilton Rating Scale for Anxiety Exclusion Criteria: Women who are pregnant or who will be breastfeeding during the study Patients with a history of: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanna Forero, MA
Organizational Affiliation
Forest Research Institute, a subsidiary of Actavis plc.
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 023
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Forest Investigative Site 013
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Forest Investigative Site 036
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Forest Investigative Site 001
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Forest Investigative Site 009
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Forest Investigative Site 026
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Forest Investigative Site 017
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Forest Investigative Site 034
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Forest Investigative Site 030
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Forest Investigative Site 029
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Forest Investigative Site 035
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Forest Investigative Site 032
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 021
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Forest Investigative Site 025
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Forest Investigative Site 018
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Forest Investigative Site 022
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Forest Investigative Site 014
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Forest Investigative Site 005
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Forest Investigative Site 015
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Forest Investigative Site 027
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Forest Investigative Site 028
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
Country
United States
Facility Name
Forest Investigative Site 010
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Forest Investigative Site 002
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Forest Investigative Site 004
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Forest Investigative Site 003
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Forest Investigative Site 007
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Forest Investigative Site 020
City
New York
State/Province
New York
ZIP/Postal Code
10168
Country
United States
Facility Name
Forest Investigative Site 019
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Forest Investigative Site 008
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Forest Investigative Site 037
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Forest Investigative Site 011
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Forest Investigative Site 033
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site 031
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Forest Investigative Site 012
City
Herndon
State/Province
Virginia
ZIP/Postal Code
20170
Country
United States
Facility Name
Forest Investigative Site 016
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Forest Investigative Site 024
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
27232052
Citation
Durgam S, Gommoll C, Forero G, Nunez R, Tang X, Mathews M, Sheehan DV. Efficacy and Safety of Vilazodone in Patients With Generalized Anxiety Disorder: A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Trial. J Clin Psychiatry. 2016 Dec;77(12):1687-1694. doi: 10.4088/JCP.15m09885.
Results Reference
derived

Learn more about this trial

Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder

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