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Safety and Efficacy of Vilazodone in Major Depressive Disorder (VLZ-MD-01)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01473381
First received: November 14, 2011
Last updated: August 6, 2014
Last verified: August 2014

November 14, 2011
August 6, 2014
December 2011
June 2013   (final data collection date for primary outcome measure)
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10 [ Time Frame: Baseline to Week 10 ] [ Designated as safety issue: No ]
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.
Montgomery-Åsberg Depression Rating Scale (MÅDRS) [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01473381 on ClinicalTrials.gov Archive Site
  • Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score [ Time Frame: Baseline to Week 10 ] [ Designated as safety issue: No ]
    The Clinical Global Impressions-Severity scale is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. In particular, the clinician is asked to respond to the following question: "Considering your total clinical experience with this population, how mentally ill is the patient at this time?" The patient is rated on the following 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. A higher score indicates more mental illness. A negative change score indicates improvement.
  • Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response [ Time Frame: Baseline to Week 10 ] [ Designated as safety issue: No ]
    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 MADRS sustained response was defined as a MADRS total score ≤ 12 for at least the last 2 visits during the double-blind treatment period (Weeks 1-10). A total MADRS score ≤ 12 corresponds to an average score of 1 per item and is indicative of very low level of depressive symptoms.
  • Clinical Global Impressions - Severity (CGI-S) [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
  • MÅDRS Sustained Remission [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Vilazodone in Major Depressive Disorder
A Double-blind, Placebo- and Active-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Vilazodone
    Vilazodone was supplied as film-coated tablets.
    Other Name: Viibryd
  • Drug: Placebo to citalopram
    Placebo to citalopram was supplied as a capsule.
    Other Name: Celexa
  • Drug: Placebo to vilazodone
    Placebo to vilazodone was supplied as film-coated tablets.
  • Drug: Citalopram
    Citalopram was supplied as encapsulated tablets.
    Other Name: Celexa
  • Placebo Comparator: Placebo
    Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
    Interventions:
    • Drug: Placebo to citalopram
    • Drug: Placebo to vilazodone
  • Experimental: Vilazodone 20 mg/day
    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.
    Interventions:
    • Drug: Vilazodone
    • Drug: Placebo to citalopram
    • Drug: Placebo to vilazodone
  • Experimental: Vilazodone 40 mg/day
    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.
    Interventions:
    • Drug: Vilazodone
    • Drug: Placebo to citalopram
    • Drug: Placebo to vilazodone
  • Active Comparator: Citalopram 40 mg/day
    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.
    Interventions:
    • Drug: Placebo to vilazodone
    • Drug: Citalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1162
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01473381
VLZ-MD-01
No
Forest Laboratories
Forest Laboratories
Not Provided
Study Director: Carl Gommoll, MS Forest Laboratories
Forest Laboratories
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP