Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder

NCT01473394 | Completed Phase 4 Results

• 1 other identifier: VLZ-MD-03
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study was to further characterize the efficacy, safety, and tolerability of a single fixed dose level 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 8

  The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Patients were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. 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 on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.

  Baseline to Week 8

Secondary Outcomes (2)

• Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8

  Baseline to Week 8

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

  Baseline to Week 8

Study Arms (2)

Dose-matched placebo

PLACEBO COMPARATOR

Participants received dose-matched placebo orally once daily for 9 weeks.

Drug: Dose-matched placebo

Vilazodone

EXPERIMENTAL

Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.

Drug: Vilazodone

Interventions

Dose-matched placebo DRUG

Dose-matched placebo was supplied as tablets.

Dose-matched placebo

Vilazodone DRUG

Vilazodone was supplied as tablets.

Also known as: Viibryd

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:

• 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 (14)

Forest Investigative Site 009

Beverly Hills, California, 90210, United States

Location

Forest Investigative Site 003

Encino, California, 91316, United States

Location

Forest Investigative Site 010

New Port Beach, California, 92660, United States

Location

Forest Investigative Site 005

Jacksonville, Florida, 32216, United States

Location

Forest Investigative Site 004

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 012

Atlanta, Georgia, 30328, United States

Location

Forest Investigative Site 001

Baltimore, Maryland, 21285, United States

Location

Forest Investigative Site 002

Dayton, Ohio, 45417, United States

Location

Forest Investigative Site 011

Philadelphia, Pennsylvania, 19104, United States

Location

Forest Investigative Site 015

Lincoln, Rhode Island, 02865, United States

Location

Forest Investigative Site 008

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site 016

San Antonio, Texas, 78229, United States

Location

Forest Investigative Site 006

Bellevue, Washington, 98007, United States

Location

Forest Investigative Site 013

Seattle, Washington, 98104, United States

Location

Related Publications (3)

• 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

• Croft HA, Pomara N, Gommoll C, Chen D, Nunez R, Mathews M. Efficacy and safety of vilazodone in major depressive disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2014 Nov;75(11):e1291-8. doi: 10.4088/JCP.14m08992.

  PMID: 25470094 DERIVED

• Citrome L, Gommoll CP, Tang X, Nunez R, Mathews M. Evaluating the efficacy of vilazodone in achieving remission in patients with major depressive disorder: post-hoc analyses of a phase IV trial. Int Clin Psychopharmacol. 2015 Mar;30(2):75-81. doi: 10.1097/YIC.0000000000000056.

  PMID: 25396353 DERIVED

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

Results Point of Contact

• Title: Carl Gommoll
• Organization: Forest Research Institute, Inc.

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: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 3, 2014
• Results First Posted: April 3, 2014

Record last verified: 2014-02

Locations

US (14)