Safety and Efficacy of Vilazodone in Major Depressive Disorder

NCT01473381 | Completed Phase 4 Results

• 1 other identifier: VLZ-MD-01
• Study Type: interventional
• Target: 1,162
• Locations: 1 country
• Sites: 54

Brief Summary

The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Depression

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10

  The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A negative change score indicates improvement.

  Baseline to Week 10

Secondary Outcomes (2)

• Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score

  Baseline to Week 10

• Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response

  Baseline to Week 10

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.

Drug: Placebo to citalopram; Drug: Placebo to vilazodone

Vilazodone 20 mg/day

EXPERIMENTAL

Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.

Drug: Vilazodone; Drug: Placebo to citalopram; Drug: Placebo to vilazodone

Vilazodone 40 mg/day

EXPERIMENTAL

Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.

Drug: Vilazodone; Drug: Placebo to citalopram; Drug: Placebo to vilazodone

Citalopram 40 mg/day

ACTIVE COMPARATOR

Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.

Drug: Placebo to vilazodone; Drug: Citalopram

Interventions

Vilazodone DRUG

Vilazodone was supplied as film-coated tablets.

Also known as: Viibryd

Vilazodone 20 mg/day; Vilazodone 40 mg/day

Placebo to citalopram DRUG

Placebo to citalopram was supplied as a capsule.

Also known as: Celexa

Placebo; Vilazodone 20 mg/day; Vilazodone 40 mg/day

Placebo to vilazodone DRUG

Placebo to vilazodone was supplied as film-coated tablets.

Citalopram 40 mg/day; Placebo; Vilazodone 20 mg/day; Vilazodone 40 mg/day

Citalopram DRUG

Citalopram was supplied as encapsulated tablets.

Also known as: Celexa

Citalopram 40 mg/day

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 Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (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 12 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
• Mental retardation, dementia, amnesia, or other cognitive disorders.
• Patients who are considered a suicide risk.

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (54)

Forest Investigative Site 036

Birmingham, Alabama, 35216, United States

Location

Forest Investigative Site 016

Dothan, Alabama, 36303, United States

Location

Forest Investigative Site 033

Scottsdale, Arizona, 85254, United States

Location

Forest Investigative Site 027

Fayetteville, Arkansas, 72703, United States

Location

Forest Investigative Site 029

Cerritos, California, 90703, United States

Location

Forest Investigative Site 002

Costa Mesa, California, 92626, United States

Location

Forest Investigative Site 019

Murrieta, California, 92562, United States

Location

Forest Investigative Site 025

Oceanside, California, 90703, United States

Location

Forest Investigative Site 043

Orange, California, 92868, United States

Location

Forest Investigative Site 003

Redlands, California, 92374, United States

Location

Forest Investigative Site 046

Sherman Oaks, California, 33026, United States

Location

Forest Investigative Site 057

Upland, California, 91786, United States

Location

Forest Investigative Site 034

Cromwell, Connecticut, 06416, United States

Location

Forest Investigative Site 038

Fort Myers, Florida, 33912, United States

Location

Forest Investigative Site 018

Gainsville, Florida, 32607, United States

Location

Forest Investigative Site 055

Hallandale, Florida, 33003, United States

Location

Forest Investigative Site 063

Jacksonville, Florida, 32256, United States

Location

Forest Investigative Site 035

Miami, Florida, 33134, United States

Location

Forest Investigative Site 030

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 062

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 045

Pembroke Pines, Florida, 33026, United States

Location

Forest Investigative Site 051

Tampa, Florida, 33613, United States

Location

Forest Investigative Site 032

West Palm Beach, Florida, 33407, United States

Location

Forest Investigative Site 022

Winter Park, Florida, 32789, United States

Location

Forest Investigative Site 060

Atlanta, Georgia, 30328, United States

Location

Forest Investigative Site 037

Chicago, Illinois, 60634, United States

Location

Forest Investigative Site 050

Chicago, Illinois, 60640, United States

Location

Forest Investigative Site 040

Indianapolis, Indiana, 46260, United States

Location

Forest Investigative Site 012

Lafayette, Indiana, 47905, United States

Location

Forest Investigative Site 053

Prairie Village, Kansas, 66206, United States

Location

Forest Investigative Site 020

Baltimore, Maryland, 21208, United States

Location

Forest Investigative Site 031

Boston, Massachusetts, 02135, United States

Location

Forest Investigative Site 061

Las Vegas, Nevada, 89102, United States

Location

Forest Investigative Site 024

Willingboro, New Jersey, 08046, United States

Location

Forest Investigative Site 010

Albuquerque, New Mexico, 87109, United States

Location

Forest Investigative Site 011

Albuquerque, New Mexico, 87109, United States

Location

Forest Investigative Site 004

Brooklyn, New York, 11214, United States

Location

Forest Investigative Site 007

Cedarhurst, New York, 11516, United States

Location

Forest Investigative Site 058

New York, New York, 10003, United States

Location

Forest Investigative Site 047

New York, New York, 10021, United States

Location

Forest Investigative Site 039

Cincinnati, Ohio, 45227, United States

Location

Forest Investigative Site 042

Oklahoma City, Oklahoma, 73112, United States

Location

Forest Investigative Site 048

Oklahoma City, Oklahoma, 73112, United States

Location

Forest Investigative Site 066

Portland, Oregon, 97210, United States

Location

Forest Investigative Site 014

Allentown, Pennsylvania, 18104, United States

Location

Forest Investigative Site 049

Bridgeville, Pennsylvania, 15017, United States

Location

Forest Investigative Site 064

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site 013

Austin, Texas, 78731, United States

Location

Forest Investigative Site 021

Dallas, Texas, 75230, United States

Location

Forest Investigative Site 059

Bellevue, Washington, 98007, United States

Location

Forest Investigative Site 065

Seattle, Washington, 98104, United States

Location

Forest Investigative Site 054

Spokane, Washington, 99204, United States

Location

Forest Investigative Site 052

Middleton, Wisconsin, 53562, United States

Location

Forest Investigative Site 056

Milwaukee, Wisconsin, 53223, United States

Location

Related Publications (4)

• Kornstein S, Chang CT, Gommoll CP, Edwards J. Vilazodone efficacy in subgroups of patients with major depressive disorder: a post-hoc analysis of four randomized, double-blind, placebo-controlled trials. Int Clin Psychopharmacol. 2018 Jul;33(4):217-223. doi: 10.1097/YIC.0000000000000217.

  PMID: 29608461 DERIVED

• Rele S, Millet R, Kim S, Paik JW, Kim S, Masand PS, Patkar AA. An 8-Week Randomized, Double-Blind Trial Comparing Efficacy, Safety, and Tolerability of 3 Vilazodone Dose-Initiation Strategies Following Switch From SSRIs and SNRIs in Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Aug 6;17(4):10.4088/PCC.14m01734. doi: 10.4088/PCC.14m01734. eCollection 2015.

  PMID: 26693034 DERIVED

• Clayton AH, Gommoll C, Chen D, Nunez R, Mathews M. Sexual dysfunction during treatment of major depressive disorder with vilazodone, citalopram, or placebo: results from a phase IV clinical trial. Int Clin Psychopharmacol. 2015 Jul;30(4):216-23. doi: 10.1097/YIC.0000000000000075.

  PMID: 26039688 DERIVED

• Mathews M, Gommoll C, Chen D, Nunez R, Khan A. Efficacy and safety of vilazodone 20 and 40 mg in major depressive disorder: a randomized, double-blind, placebo-controlled trial. Int Clin Psychopharmacol. 2015 Mar;30(2):67-74. doi: 10.1097/YIC.0000000000000057.

  PMID: 25500685 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Vilazodone Hydrochloride; Citalopram

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; Propylamines; Amines; Organic Chemicals; Nitriles

Results Point of Contact

• Title: Suresh Durgam, MD Clinical Asset Lead for Vilazodone - Senior Director - Clinical Development
• Organization: Forest Research Institute

suresh.durgam@frx.com

201 427-8000

Study Officials

• Carl Gommoll, MS

  Forest Laboratories

  STUDY DIRECTOR

Publication Agreements

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

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: November 14, 2011
• First Posted: November 17, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 8, 2014
• Results First Posted: August 8, 2014

Record last verified: 2014-08

Locations

US (54)