Safety and Efficacy of Vilazodone in Major Depressive Disorder

NCT01573598 | Completed Phase 4

• 1 other identifier: VLZ-MD-02
• Study Type: interventional
• Target: 1,219
• Locations: 8 countries
• Sites: 75

Brief Summary

Safety and Efficacy of Vilazodone in Major Depressive Disorder

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Depression

Outcome Measures

Primary Outcomes (1)

• Time to first relapse during the double-blind treatment phase

  Number of days from the randomization date to the relapse date, up to 28 weeks.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Dose-matched placebo capsules, oral administration

Drug: Placebo

Vilazodone 20mg

EXPERIMENTAL

Vilazodone tablets, 20 mg per day, oral administration

Drug: Vilazodone

Vilazodone 40mg

EXPERIMENTAL

Vilazodone tablets, 40 mg per day, oral administration

Drug: Vilazodone

Interventions

Placebo DRUG

Matching placebo given orally, once per day

Placebo

Vilazodone DRUG

Vilazodone, 20 mg per day, oral administration

Also known as: Viibryd

Vilazodone 20mg

Eligibility Criteria

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

You may qualify if:

• Men and women, 18-70 years of age
• Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
• The patient's current major depressive episode must be at least 8 weeks and no longer than 18 months in duration

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; h. mental retardation, dementia, amnesia, or other cognitive disorders
• Patients who are considered a suicide risk

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (75)

Forest Investigative Site 030

Beverly Hills, California, 90210, United States

Location

Forest Investigative Site 012

Chino, California, 91710, United States

Location

Forest Investigative Site 022

Costa Mesa, California, 92626, United States

Location

Forest Investigative Site 017

Los Angeles, California, 90024, United States

Location

Forest Investigative Site 005

Newport Beach, California, 92660, United States

Location

Forest Investigative Site 027

Riverside, California, 92506, United States

Location

Forest Investigative Site 026

San Diego, California, 92103, United States

Location

Forest Investigative Site 016

Cromwell, Connecticut, 06416, United States

Location

Forest Investigative Site 029

Hartford, Connecticut, 06106, United States

Location

Forest Investigative Site 020

Doral, Florida, 33172, United States

Location

Forest Investigative Site 007

Fort Lauderdale, Florida, 33313, United States

Location

Forest Investigative Site 006

Fort Myers, Florida, 33912, United States

Location

Forest Investigative Site 004

Hallandale, Florida, 33009, United States

Location

Forest Investigative Site 039

Jacksonville, Florida, 32256, United States

Location

Forest Investigative Site 008

Jacksonville Beach, Florida, 32250, United States

Location

Forest Investigative Site 015

Leesburg, Florida, 34748, United States

Location

Forest Investigative Site 035

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 001

West Palm Beach, Florida, 33407, United States

Location

Forest Investigative Site 034

Winter Park, Florida, 32789, United States

Location

Forest Investigative Site 019

Hoffman Estates, Illinois, 60169, United States

Location

Forest Investigative Site 021

Indianapolis, Indiana, 46260, United States

Location

Forest Investigative Site 003

Boston, Massachusetts, 02131, United States

Location

Forest Investigative Site 013

Weymouth, Massachusetts, 02190, United States

Location

Forest Investigative Site 028

Rochester Hills, Michigan, 48307, United States

Location

Forest Investigative Site 038

Brooklyn, New York, 11214, United States

Location

Forest Investigative Site 037

New York, New York, 10003, United States

Location

Forest Investigative Site 032

New York, New York, 10021, United States

Location

Forest Investigative Site 009

New York, New York, 10032, United States

Location

Forest Investigative Site 014

Durham, North Carolina, 27705, United States

Location

Forest Investigative Site 025

Oklahoma City, Oklahoma, 73103, United States

Location

Forest Investigative Site 024

Oklahoma City, Oklahoma, 73112, United States

Location

Forest Investigative Site 036

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site 023

Dallas, Texas, 75080, United States

Location

Forest Investigative Site 011

Houston, Texas, 77079, United States

Location

Forest Investigative Site 010

Plano, Texas, 75093, United States

Location

Forest Investigative Site 002

San Antonio, Texas, 78229, United States

Location

Forest Investigative Site 031

Richmond, Virginia, 23298, United States

Location

Forest Investigative Site 033

Bellevue, Washington, 98007, United States

Location

Forest Investigative Site 103

Pleven, 5800, Bulgaria

Location

Forest Investigative Site 104

Plovdiv, 4002, Bulgaria

Location

Forest Investigative Site 106

Sofia, 1000, Bulgaria

Location

Forest Investigative Site 102

Sofia, 1632, Bulgaria

Location

Forest Investigative Site 304

Helsinki, Etelä-Suomen Lääni, 00100, Finland

Location

Forest Investigative Site 305

Helsinki, Etelä-Suomen Lääni, 00100, Finland

Location

Forest Investigative Site 301

Helsinki, Etelä-Suomen Lääni, FI-02600, Finland

Location

Forest Investigative Site 303

Rauma, Länsi-Suomen Lääni, FI-26100, Finland

Location

Forest Investigative Site 302

Kuopio, 70110, Finland

Location

Forest Investigative Site 306

Turku, 20100, Finland

Location

Forest Investigative Site 307

Turku, 20100, Finland

Location

Forest Investigative Site 401

Hanover, Lower Saxony, 30159, Germany

Location

Forest Investigative Site 405

Dresden, Saxony, 1069, Germany

Location

Forest Investigative Site 403

Berlin, 10629, Germany

Location

Forest Investigative Site 408

Berlin, 13156, Germany

Location

Forest Investigative Site 407

Chemnitz, 09111, Germany

Location

Forest Investigative Site 402

Hüttenberg, 35625, Germany

Location

Forest Investigative Site 409

Münster, 48129, Germany

Location

Forest Investigative Site 404

Nuremberg, 90419, Germany

Location

Forest Investigative Site 406

Westerstede, 26655, Germany

Location

Forest Investigative Site 602

Bucharest, București, 7000, Romania

Location

Forest Investigative Site 601

Arad, 310022, Romania

Location

Forest Investigative Site 603

Iași, 700282, Romania

Location

Forest Investigative Site 705

Petrozavodsk, Kareliya, Respublika, 185001, Russia

Location

Forest Investigative Site 701

Moscow, 115419, Russia

Location

Forest Investigative Site 804

Belgrade, Beograd, 11000, Serbia

Location

Forest Investigative Site 806

Niš, Nišava, 18000, Serbia

Location

Forest Investigative Site 801

Belgrade, 11000, Serbia

Location

Forest Investigative Site 802

Belgrade, 11000, Serbia

Location

Forest Investigative Site 803

Kragujevac, 34000, Serbia

Location

Forest Investigative Site 805

Kragujevac, Šumadija, 34000, Serbia

Location

Forest Investigative Site 903

Kherson, Kherson Oblast, 73488, Ukraine

Location

Forest Investigative Site 905

Luhansk, Luhansk Oblast, 91045, Ukraine

Location

Forest Investigative Site 901

Lviv, Lviv Oblast, 79021, Ukraine

Location

Forest Investigative Site 906

Odesa, Odesa Oblast, 67513, Ukraine

Location

Forest Investigative Site 902

Dnipropetrovsk, 49005, Ukraine

Location

Forest Investigative Site 904

Simferopol, 95006, Ukraine

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Vilazodone Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles

Study Officials

• Carrie Reichley

  Forest Research Institute, a subsidiary of Actavis plc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• 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 4, 2012
• First Posted: April 9, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: May 18, 2015

Record last verified: 2015-05

Locations

BU (4); RU (2); US (38); RO (3); SE (6); FI (7); DE (9); UA (6)