Major Depressive Disorder Clinical Trial
— VLZ-MD-01Official title:
A Double-blind, Placebo- and Active-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder
Verified date | August 2014 |
Source | Forest Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1162 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Forest Investigative Site 010 | Albuquerque | New Mexico |
United States | Forest Investigative Site 011 | Albuquerque | New Mexico |
United States | Forest Investigative Site 014 | Allentown | Pennsylvania |
United States | Forest Investigative Site 060 | Atlanta | Georgia |
United States | Forest Investigative Site 013 | Austin | Texas |
United States | Forest Investigative Site 020 | Baltimore | Maryland |
United States | Forest Investigative Site 059 | Bellevue | Washington |
United States | Forest Investigative Site 036 | Birmingham | Alabama |
United States | Forest Investigative Site 031 | Boston | Massachusetts |
United States | Forest Investigative Site 049 | Bridgeville | Pennsylvania |
United States | Forest Investigative Site 004 | Brooklyn | New York |
United States | Forest Investigative Site 007 | Cedarhurst | New York |
United States | Forest Investigative Site 029 | Cerritos | California |
United States | Forest Investigative Site 037 | Chicago | Illinois |
United States | Forest Investigative Site 050 | Chicago | Illinois |
United States | Forest Investigative Site 039 | Cincinnati | Ohio |
United States | Forest Investigative Site 002 | Costa Mesa | California |
United States | Forest Investigative Site 034 | Cromwell | Connecticut |
United States | Forest Investigative Site 021 | Dallas | Texas |
United States | Forest Investigative Site 016 | Dothan | Alabama |
United States | Forest Investigative Site 027 | Fayetteville | Arkansas |
United States | Forest Investigative Site 038 | Fort Myers | Florida |
United States | Forest Investigative Site 018 | Gainsville | Florida |
United States | Forest Investigative Site 055 | Hallandale Beach | Florida |
United States | Forest Investigative Site 040 | Indianapolis | Indiana |
United States | Forest Investigative Site 063 | Jacksonville | Florida |
United States | Forest Investigative Site 012 | Lafayette | Indiana |
United States | Forest Investigative Site 061 | Las Vegas | Nevada |
United States | Forest Investigative Site 064 | Memphis | Tennessee |
United States | Forest Investigative Site 035 | Miami | Florida |
United States | Forest Investigative Site 052 | Middleton | Wisconsin |
United States | Forest Investigative Site 056 | Milwaukee | Wisconsin |
United States | Forest Investigative Site 019 | Murrieta | California |
United States | Forest Investigative Site 047 | New York | New York |
United States | Forest Investigative Site 058 | New York City | New York |
United States | Forest Investigative Site 025 | Oceanside | California |
United States | Forest Investigative Site 042 | Oklahoma City | Oklahoma |
United States | Forest Investigative Site 048 | Oklahoma City | Oklahoma |
United States | Forest Investigative Site 043 | Orange | California |
United States | Forest Investigative Site 030 | Orlando | Florida |
United States | Forest Investigative Site 062 | Orlando | Florida |
United States | Forest Investigative Site 045 | Pembroke Pines | Florida |
United States | Forest Investigative Site 066 | Portland | Oregon |
United States | Forest Investigative Site 053 | Prairie Village | Kansas |
United States | Forest Investigative Site 003 | Redlands | California |
United States | Forest Investigative Site 033 | Scottsdale | Arizona |
United States | Forest Investigative Site 065 | Seattle | Washington |
United States | Forest Investigative Site 046 | Sherman Oaks | California |
United States | Forest Investigative Site 054 | Spokane | Washington |
United States | Forest Investigative Site 051 | Tampa | Florida |
United States | Forest Investigative Site 057 | Upland | California |
United States | Forest Investigative Site 032 | West Palm Beach | Florida |
United States | Forest Investigative Site 024 | Willingboro | New Jersey |
United States | Forest Investigative Site 022 | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score | 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. | Baseline to Week 10 | No |
Secondary | Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response | 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. | Baseline to Week 10 | No |
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