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Trial record 4 of 1917 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND Depressive Disorder, Major

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

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ClinicalTrials.gov Identifier: NCT01473394
Recruitment Status : Completed
First Posted : November 17, 2011
Results First Posted : April 3, 2014
Last Update Posted : April 3, 2014
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Tracking Information
First Submitted Date  ICMJE November 14, 2011
First Posted Date  ICMJE November 17, 2011
Results First Submitted Date  ICMJE February 21, 2014
Results First Posted Date  ICMJE April 3, 2014
Last Update Posted Date April 3, 2014
Study Start Date  ICMJE December 2011
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2014)
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2011)
Montgomery-Åsberg Depression Rating Scale (MÅDRS) [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT01473394 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2014)
  • Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2011)
  • Clinical Global Impressions - Severity (CGI-S) [ Time Frame: 8 weeks ]
  • MÅDRS Response [ Time Frame: 8 weeks ]
  • Hamilton Rating Scale for Anxiety (HAM-A) [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder
Official Title  ICMJE A Double-blind, Placebo-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Dose-matched placebo
    Dose-matched placebo was supplied as tablets.
  • Drug: Vilazodone
    Vilazodone was supplied as tablets.
    Other Name: Viibryd
Study Arms  ICMJE
  • Placebo Comparator: Dose-matched placebo
    Participants received dose-matched placebo orally once daily for 9 weeks.
    Intervention: Drug: Dose-matched placebo
  • Experimental: 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.
    Intervention: Drug: Vilazodone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2013)
518
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2011)
500
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01473394
Other Study ID Numbers  ICMJE VLZ-MD-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Forest Laboratories
Study Sponsor  ICMJE Forest Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Carl Gommoll, MS Forest Laboratories
PRS Account Forest Laboratories
Verification Date February 2014

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