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).
Brief Title
Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder
Categories
Completion Date
Completion Date Type
Actual
Conditions
Generalized Anxiety Disorder
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:
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Generalized Anxiety Disorder, GAD
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
70 Years
Minimum Age
18 Years
NCT Id
NCT01844115
Org Class
Industry
Org Full Name
Forest Laboratories
Org Study Id
VLZ-MD-07
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Double-Blind, Placebo-Controlled, Flexible-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.
Primary Outcomes
Outcome 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.
Outcome Measure
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Outcome Time Frame
Baseline to Week 8
Secondary Outcomes
Outcome 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).
Outcome Time Frame
Baseline to Week 8
Outcome Measure
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
70
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Gregory Asnis
Investigator Email
gasnis@montefiore.org
Investigator Phone