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

Phase 3

Completed

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

• Registration Number: NCT01844115
• 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: 2013-04-27
• Study First Submitted QC: 2013-04-29
• Study Start: 2013-04-30
• Study First Posted: 2013-05-01
• Primary Completion: 2014-03-31
• 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: 415

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Dose-matched placebo tablets, oral administration
Vilazodone	Vilazodone	Vilazodone tablets, 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 (36)

Forest Investigative Site 023; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 013; 🇺🇸 Phoenix, Arizona, United States

Forest Investigative Site 036; 🇺🇸 Beverly Hills, California, United States

Forest Investigative Site 001; 🇺🇸 Costa Mesa, California, United States

Forest Investigative Site 009; 🇺🇸 Oceanside, California, United States

Forest Investigative Site 026; 🇺🇸 Rancho Mirage, California, United States

Forest Investigative Site 017; 🇺🇸 Sherman Oaks, California, United States

Forest Investigative Site 034; 🇺🇸 Sherman Oaks, California, United States

Forest Investigative Site 030; 🇺🇸 Bradenton, Florida, United States

Forest Investigative Site 029; 🇺🇸 Gainesville, Florida, United States

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