Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder

Phase 3

Completed

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

• Registration Number: NCT01766401
• 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: 2013-01-09
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-11
• Study Start: 2013-01-31
• Primary Completion: 2014-01-29
• Study Completion: 2014-01-29
• 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: 402

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vilazadone	Vilazadone	Vilazadone tablets, oral administration
Placebo	Placebo	Matching placebo tablets, oral administration

Primary Outcome Measures

Name	Time	Method
Change in 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 (30)

Forest Investigative Site 029; 🇺🇸 Shreveport, Louisiana, United States

Forest Investigative Site 003; 🇺🇸 Canton, Ohio, United States

Forest Investigative Site 015; 🇺🇸 Philadelphia, Pennsylvania, United States

Forest Investigative Site 018; 🇺🇸 Houston, Texas, United States

Forest Investigative Site 019; 🇺🇸 Las Vegas, Nevada, United States

Forest Investigative Site 013; 🇺🇸 Woodstock, Vermont, United States

Forest Investigative Site 030; 🇺🇸 Oklahoma City, Oklahoma, United States

Forest Investigative Site 011; 🇺🇸 Murray, Utah, United States

Forest Investigative Site 027; 🇺🇸 Lincoln, Rhode Island, United States

Forest Investigative Site 031; 🇺🇸 Columbus, Ohio, United States

Forest Investigative Site 021; 🇺🇸 Mason, Ohio, United States

Forest Investigative Site 005; 🇺🇸 Salem, Oregon, United States

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

Forest Investigative Site 010; 🇺🇸 Encino, California, United States

Forest Investigative Site 022; 🇺🇸 Arcadia, California, United States

Forest Investigative Site 025; 🇺🇸 Newport Beach, California, United States

Forest Investigative Site 023; 🇺🇸 Beverly Hills, California, United States

Forest Investigative Site 004; 🇺🇸 Redlands, California, United States

Forest Investigative Site 016; 🇺🇸 Temecula, California, United States

Forest Investigative Site 007; 🇺🇸 Sherman Oaks, California, United States

Forest Investigative Site 017; 🇺🇸 Coral Springs, Florida, United States

Forest Investigative Site 002; 🇺🇸 Jacksonville, Florida, United States

Forest Investigative Site 024; 🇺🇸 Miami, Florida, United States

Forest Investigative Site 001; 🇺🇸 Orlando, Florida, United States

Forest Investigative Site 026; 🇺🇸 Indianapolis, Indiana, United States

Forest Investigative Site 014; 🇺🇸 Allentown, Pennsylvania, United States

Forest Investigative Site 008; 🇺🇸 Houston, Texas, United States

Forest Investigative Site 028; 🇺🇸 Fort Myers, Florida, United States

Forest Investigative Site 020; 🇺🇸 Leesburg, Florida, United States

Forest Investigative Site 012; 🇺🇸 Upland, California, United States