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Completed

NCT Number: NCT01629966

Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder

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)

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Forest Investigative Site 001, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Placebo

Drug

Matching 10 mg and 20 mg placebo tablets, once per day, oral administration,

Vilazodone

Drug

Vilazodone, 20mg, oral administration once per day.

Primary outcomes

  1. Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score

    Time frame: 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 outcomes

  1. Change From Baseline in the Sheehan Disability Scale (SDS) Total Score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

A Double-blind, Placebo-Controlled Fixed-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.

Acronym: VLZ-MD-05

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 28, 2012
Registry last updated
Dec 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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