Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder

Phase 3

Completed

• Conditions: Generalized Anxiety Disorder
• Interventions: Drug: Vilazodone; Drug: Placebo

• Registration Number: NCT01629966
• Lead Sponsor: Forest Laboratories

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-28
• Study Start: 2012-06-30
• Primary Completion: 2014-02-28
• Study Completion: 2014-03-31
• Disposition First Submitted: 2015-02-27
• Disposition First Submitted QC: 2015-02-27
• Disposition First Posted: 2015-03-18
• Status Verified: 2019-11
• Results First Submitted: 2019-12-04
• Results First Submitted QC: 2019-12-04
• Last Update Submitted: 2019-12-04
• Results First Posted: 2019-12-18
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 680

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vilazadone 20mg	Vilazodone	Vilazodone 20mg once per day, oral administration.
Placebo	Placebo	Dose-matched placebo one per day, oral administration
Vilazodone 40mg	Vilazodone	Vilazodone 40mg once per day, oral administration

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	Baseline to Week 8	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

Name	Time	Method
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score	Baseline to Week 8	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).

Trial Locations

Locations (37)

Forest Investigative Site 038; 🇺🇸 Atlanta, Georgia, United States

Forest Investigative Site 025; 🇺🇸 Boston, Massachusetts, United States

Forest Investigative Site 016; 🇺🇸 Berlin, New Jersey, United States

Forest Investigative Site 021; 🇺🇸 Beverly Hills, California, United States

Forest Investigative Site 023; 🇺🇸 Glendale, California, United States

Forest Investigative Site 011; 🇺🇸 Paramount, California, United States

Forest Investigative Site 005; 🇺🇸 Delray Beach, Florida, United States

Forest Investigative Site 014; 🇺🇸 Oakland Park, Florida, United States

Forest Investigative Site 019; 🇺🇸 South Miami, Florida, United States

Forest Investigative Site 035; 🇺🇸 Decatur, Georgia, United States

Forest Investigative Site 028; 🇺🇸 Chicago, Illinois, United States

Forest Investigative Site 033; 🇺🇸 Wichita, Kansas, United States

Forest Investigative Site 030; 🇺🇸 Schaumburg, Illinois, United States

Forest Investigative Site 029; 🇺🇸 Topeka, Kansas, United States

Forest Investigative Site 031; 🇺🇸 Baltimore, Maryland, United States

Forest Investigative Site 037; 🇺🇸 Saint Louis, Missouri, United States

Forest Investigative Site 015; 🇺🇸 Las Vegas, Nevada, United States

Forest Investigative Site 007; 🇺🇸 Brooklyn, New York, United States

Forest Investigative Site 024; 🇺🇸 New York, New York, United States

Forest Investigative Site 032; 🇺🇸 New York, New York, United States

Forest Investigative Site 012; 🇺🇸 New York, New York, United States

Forest Investigative Site 020; 🇺🇸 Bismarck, North Dakota, United States

Forest Investigative Site 008; 🇺🇸 Cincinnati, Ohio, United States

Forest Investigative Site 041; 🇺🇸 Dayton, Ohio, United States

Forest Investigative Site 017; 🇺🇸 Wichita Falls, Texas, United States

Forest Investigative Site 018; 🇺🇸 Charlottesville, Virginia, United States

Forest Investigative Site 039; 🇺🇸 Seattle, Washington, United States

Forest Investigative Site 040; 🇺🇸 Bellevue, Washington, United States

Forest Investigative Site 010; 🇺🇸 Lake Charles, Louisiana, United States

Forest Investigative Site 001; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 026; 🇺🇸 Norwich, Connecticut, United States

Forest Investigative Site 027; 🇺🇸 Waterbury, Connecticut, United States

Forest Investigative Site 006; 🇺🇸 Memphis, Tennessee, United States

Forest Investigative Site 004; 🇺🇸 Oklahoma City, Oklahoma, United States

Forest Investigative Site 034; 🇺🇸 Oklahoma City, Oklahoma, United States

Forest Investigative Site 013; 🇺🇸 Portland, Oregon, United States

Forest Investigative Site 003; 🇺🇸 Salt Lake City, Utah, United States