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

NCT01844115 | Completed Phase 3 Results

• 1 other identifier: VLZ-MD-07
• Study Type: interventional
• Target: 415
• Locations: 1 country
• Sites: 36

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).

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder, GAD

Outcome Measures

Primary Outcomes (1)

• Change From 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 Outcomes (1)

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

  Baseline to Week 8

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dose-matched placebo tablets, oral administration

Drug: Placebo

Vilazodone

EXPERIMENTAL

Vilazodone tablets, oral administration

Drug: Vilazodone

Interventions

Placebo DRUG

Also known as: Matching 10 mg and 20 mg placebo tablets, once-daily oral administration.

Placebo

Vilazodone DRUG

Viibryd

Also known as: Vilazodone, 20 mg once per day, oral administration, once daily or Vilazodone, 40 mg once daily, oral administration, once daily

Vilazodone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women who are pregnant or who will be breastfeeding during the study
• Patients with a history of:
• 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

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (36)

Forest Investigative Site 023

Birmingham, Alabama, 35216, United States

Location

Forest Investigative Site 013

Phoenix, Arizona, 85032, United States

Location

Forest Investigative Site 036

Beverly Hills, California, 90210, United States

Location

Forest Investigative Site 001

Costa Mesa, California, 92626, United States

Location

Forest Investigative Site 009

Oceanside, California, 92056, United States

Location

Forest Investigative Site 026

Rancho Mirage, California, 92270, United States

Location

Forest Investigative Site 017

Sherman Oaks, California, 91403, United States

Location

Forest Investigative Site 034

Sherman Oaks, California, 91403, United States

Location

Forest Investigative Site 030

Bradenton, Florida, 34201, United States

Location

Forest Investigative Site 029

Gainesville, Florida, 32607, United States

Location

Forest Investigative Site 035

Jacksonville, Florida, 32256, United States

Location

Forest Investigative Site 032

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 021

West Palm Beach, Florida, 33407, United States

Location

Forest Investigative Site 025

Atlanta, Georgia, 30328, United States

Location

Forest Investigative Site 018

Decatur, Georgia, 30030, United States

Location

Forest Investigative Site 022

Hoffman Estates, Illinois, 60169, United States

Location

Forest Investigative Site 014

Berlin, New Jersey, 08009, United States

Location

Forest Investigative Site 005

Cherry Hill, New Jersey, 08002, United States

Location

Forest Investigative Site 015

Albuquerque, New Mexico, 87109, United States

Location

Forest Investigative Site 028

Brooklyn, New York, 11214, United States

Location

Forest Investigative Site 010

Brooklyn, New York, 11235, United States

Location

Forest Investigative Site 002

Cedarhurst, New York, 11516, United States

Location

Forest Investigative Site 004

Mount Kisco, New York, 10549, United States

Location

Forest Investigative Site 003

New York, New York, 10003, United States

Location

Forest Investigative Site 007

New York, New York, 10021, United States

Location

Forest Investigative Site 020

New York, New York, 10168, United States

Location

Forest Investigative Site 027

The Bronx, New York, 10467, United States

Location

Forest Investigative Site 019

Dayton, Ohio, 45417, United States

Location

Forest Investigative Site 008

Portland, Oregon, 97210, United States

Location

Forest Investigative Site 037

Allentown, Pennsylvania, 18104, United States

Location

Forest Investigative Site 011

Media, Pennsylvania, 19063, United States

Location

Forest Investigative Site 033

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site 031

Dallas, Texas, 75231, United States

Location

Forest Investigative Site 012

Herndon, Virginia, 20170, United States

Location

Forest Investigative Site 016

Bellevue, Washington, 98007, United States

Location

Forest Investigative Site 024

Seattle, Washington, 98104, United States

Location

Related Publications (2)

• Khan A, Durgam S, Tang X, Ruth A, Mathews M, Gommoll CP. Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone. Prim Care Companion CNS Disord. 2016 Apr 28;18(2):10.4088/PCC.15m01904. doi: 10.4088/PCC.15m01904. eCollection 2016.

  PMID: 27486544 DERIVED

• Durgam S, Gommoll C, Forero G, Nunez R, Tang X, Mathews M, Sheehan DV. Efficacy and Safety of Vilazodone in Patients With Generalized Anxiety Disorder: A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Trial. J Clin Psychiatry. 2016 Dec;77(12):1687-1694. doi: 10.4088/JCP.15m09885.

  PMID: 27232052 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Vilazodone Hydrochloride; Administration, Oral

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Forest Research Institute, Inc

IR-CTRegistration@allergan.com

877-277-8566

Study Officials

• Giovanna Forero, MA

  Forest Research Institute, a subsidiary of Actavis plc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2013
• First Posted: May 1, 2013
• Study Start: April 30, 2013
• Primary Completion: March 31, 2014
• Study Completion: March 31, 2014
• Last Updated: December 18, 2019
• Results First Posted: December 18, 2019

Record last verified: 2019-11

Locations

US (36)