Generalized Anxiety Disorder Clinical Trial
— VLZ-MD-06Official title:
A Double-Blind, Placebo-Controlled, Flexible-Dose Study of Vilazadone in Patients With Generalized Anxiety Disorder
Verified date | November 2019 |
Source | Forest Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 402 |
Est. completion date | January 29, 2014 |
Est. primary completion date | January 29, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Forest Investigative Site 014 | Allentown | Pennsylvania |
United States | Forest Investigative Site 022 | Arcadia | California |
United States | Forest Investigative Site 023 | Beverly Hills | California |
United States | Forest Investigative Site 003 | Canton | Ohio |
United States | Forest Investigative Site 031 | Columbus | Ohio |
United States | Forest Investigative Site 017 | Coral Springs | Florida |
United States | Forest Investigative Site 010 | Encino | California |
United States | Forest Investigative Site 028 | Fort Myers | Florida |
United States | Forest Investigative Site 008 | Houston | Texas |
United States | Forest Investigative Site 018 | Houston | Texas |
United States | Forest Investigative Site 026 | Indianapolis | Indiana |
United States | Forest Investigative Site 002 | Jacksonville | Florida |
United States | Forest Investigative Site 019 | Las Vegas | Nevada |
United States | Forest Investigative Site 020 | Leesburg | Florida |
United States | Forest Investigative Site 027 | Lincoln | Rhode Island |
United States | Forest Investigative Site 021 | Mason | Ohio |
United States | Forest Investigative Site 006 | Memphis | Tennessee |
United States | Forest Investigative Site 024 | Miami | Florida |
United States | Forest Investigative Site 011 | Murray | Utah |
United States | Forest Investigative Site 025 | Newport Beach | California |
United States | Forest Investigative Site 030 | Oklahoma City | Oklahoma |
United States | Forest Investigative Site 001 | Orlando | Florida |
United States | Forest Investigative Site 015 | Philadelphia | Pennsylvania |
United States | Forest Investigative Site 004 | Redlands | California |
United States | Forest Investigative Site 005 | Salem | Oregon |
United States | Forest Investigative Site 007 | Sherman Oaks | California |
United States | Forest Investigative Site 029 | Shreveport | Louisiana |
United States | Forest Investigative Site 016 | Temecula | California |
United States | Forest Investigative Site 012 | Upland | California |
United States | Forest Investigative Site 013 | Woodstock | Vermont |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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