NCT01766401

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2013

Completed
20 days until next milestone

Study Start

First participant enrolled

January 31, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2014

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

December 18, 2019

Completed
Last Updated

December 18, 2019

Status Verified

November 1, 2019

Enrollment Period

12 months

First QC Date

January 9, 2013

Results QC Date

December 4, 2019

Last Update Submit

December 4, 2019

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety DisorderGAD

Outcome Measures

Primary Outcomes (1)

  • Change in 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

Matching placebo tablets, oral administration

Drug: Placebo

Vilazadone

EXPERIMENTAL

Vilazadone tablets, oral administration

Drug: Vilazadone

Interventions

PlaceboDRUG
Also known as: Dose-matched placebo tablets, oral administration, once per day
Placebo
VilazadoneDRUG

Viibryd

Also known as: Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.
Vilazadone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Forest Investigative Site 022

Arcadia, California, 91007, United States

Location

Forest Investigative Site 023

Beverly Hills, California, 90210, United States

Location

Forest Investigative Site 010

Encino, California, 91316, United States

Location

Forest Investigative Site 025

Newport Beach, California, 92660, United States

Location

Forest Investigative Site 004

Redlands, California, 92374, United States

Location

Forest Investigative Site 007

Sherman Oaks, California, 91403, United States

Location

Forest Investigative Site 016

Temecula, California, 92562, United States

Location

Forest Investigative Site 012

Upland, California, 91786, United States

Location

Forest Investigative Site 017

Coral Springs, Florida, 33067, United States

Location

Forest Investigative Site 028

Fort Myers, Florida, 33912, United States

Location

Forest Investigative Site 002

Jacksonville, Florida, 32256, United States

Location

Forest Investigative Site 020

Leesburg, Florida, 34748, United States

Location

Forest Investigative Site 024

Miami, Florida, 33015, United States

Location

Forest Investigative Site 001

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 026

Indianapolis, Indiana, 46260, United States

Location

Forest Investigative Site 029

Shreveport, Louisiana, 71104, United States

Location

Forest Investigative Site 019

Las Vegas, Nevada, 89102, United States

Location

Forest Investigative Site 003

Canton, Ohio, 44718, United States

Location

Forest Investigative Site 031

Columbus, Ohio, 43210, United States

Location

Forest Investigative Site 021

Mason, Ohio, 45040, United States

Location

Forest Investigative Site 030

Oklahoma City, Oklahoma, 73112, United States

Location

Forest Investigative Site 005

Salem, Oregon, 97301, United States

Location

Forest Investigative Site 014

Allentown, Pennsylvania, 18104, United States

Location

Forest Investigative Site 015

Philadelphia, Pennsylvania, 19139, United States

Location

Forest Investigative Site 027

Lincoln, Rhode Island, 02865, United States

Location

Forest Investigative Site 006

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site 008

Houston, Texas, 77054, United States

Location

Forest Investigative Site 018

Houston, Texas, 77096, United States

Location

Forest Investigative Site 011

Murray, Utah, 84123, United States

Location

Forest Investigative Site 013

Woodstock, Vermont, 05091, 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: 27486544DERIVED

  • Gommoll C, Forero G, Mathews M, Nunez R, Tang X, Durgam S, Sambunaris A. Vilazodone in patients with generalized anxiety disorder: a double-blind, randomized, placebo-controlled, flexible-dose study. Int Clin Psychopharmacol. 2015 Nov;30(6):297-306. doi: 10.1097/YIC.0000000000000096.

    PMID: 26291335DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Administration, Oral

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

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 Laboratories

    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

January 9, 2013

First Posted

January 11, 2013

Study Start

January 31, 2013

Primary Completion

January 29, 2014

Study Completion

January 29, 2014

Last Updated

December 18, 2019

Results First Posted

December 18, 2019

Record last verified: 2019-11

Locations

US(30)