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

Phase 4

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Dose-matched placebo; Drug: Vilazodone

• Registration Number: NCT01473394
• Lead Sponsor: Forest Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-16
• Study First Posted: 2011-11-17
• Study Start: 2011-12
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-02
• Results First Submitted: 2014-02-21
• Results First Submitted QC: 2014-02-21
• Last Update Submitted: 2014-02-21
• Results First Posted: 2014-04-03
• Last Update Posted: 2014-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 518

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose-matched placebo	Dose-matched placebo	Participants received dose-matched placebo orally once daily for 9 weeks.
Vilazodone	Vilazodone	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8	Baseline to 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8	Baseline to Week 8	The CGI-S is a clinician-rated scale for assessing the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. The clinician responded to the following question "Considering your total clinical experience with this population, how mentally ill is the participant at this time?" on a 7-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The scale ranges from 1 to 7. A higher score indicates more severe mental illness. A negative change score indicates improvement.
Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate	Baseline to Week 8	The MADRS Sustained response rate is defined as a MÅDRS total score ≤ 12 for at least the last 2 consecutive visits during the double-blind treatment period.

Trial Locations

Locations (14)

Forest Investigative Site 015; 🇺🇸 Lincoln, Rhode Island, United States

Forest Investigative Site 013; 🇺🇸 Seattle, Washington, United States

Forest Investigative Site 003; 🇺🇸 Encino, California, United States

Forest Investigative Site 009; 🇺🇸 Beverly Hills, California, United States

Forest Investigative Site 002; 🇺🇸 Dayton, Ohio, United States

Forest Investigative Site 010; 🇺🇸 New port Beach, California, United States

Forest Investigative Site 016; 🇺🇸 San Antonio, Texas, United States

Forest Investigative Site 005; 🇺🇸 Jacksonville, Florida, United States

Forest Investigative Site 001; 🇺🇸 Baltimore, Maryland, United States

Forest Investigative Site 004; 🇺🇸 Orlando, Florida, United States

Forest Investigative Site 011; 🇺🇸 Philadelphia, Pennsylvania, United States

Forest Investigative Site 012; 🇺🇸 Atlanta, Georgia, United States

Forest Investigative Site 006; 🇺🇸 Bellevue, Washington, United States

Forest Investigative Site 008; 🇺🇸 Memphis, Tennessee, United States