Safety and Efficacy of Vilazodone in Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT01473381
- Lead Sponsor
- Forest Laboratories
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1162
- 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.
-
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 Vilazodone 20 mg/day Vilazodone 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. Vilazodone 20 mg/day Placebo to citalopram 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. Vilazodone 40 mg/day Vilazodone 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. Placebo Placebo to citalopram Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Placebo Placebo to vilazodone Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Vilazodone 20 mg/day Placebo to vilazodone 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. Vilazodone 40 mg/day Placebo to citalopram 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. Vilazodone 40 mg/day Placebo to vilazodone 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. Citalopram 40 mg/day Placebo to vilazodone 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. Citalopram 40 mg/day Citalopram 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10 Baseline to 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score Baseline to Week 10 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 Baseline to 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 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.
Trial Locations
- Locations (54)
Forest Investigative Site 034
🇺🇸Cromwell, Connecticut, United States
Forest Investigative Site 014
🇺🇸Allentown, Pennsylvania, United States
Forest Investigative Site 060
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 021
🇺🇸Dallas, Texas, United States
Forest Investigative Site 031
🇺🇸Boston, Massachusetts, United States
Forest Investigative Site 065
🇺🇸Seattle, Washington, United States
Forest Investigative Site 063
🇺🇸Jacksonville, Florida, United States
Forest Investigative Site 046
🇺🇸Sherman Oaks, California, United States
Forest Investigative Site 033
🇺🇸Scottsdale, Arizona, United States
Forest Investigative Site 051
🇺🇸Tampa, Florida, United States
Forest Investigative Site 029
🇺🇸Cerritos, California, United States
Forest Investigative Site 025
🇺🇸Oceanside, California, United States
Forest Investigative Site 016
🇺🇸Dothan, Alabama, United States
Forest Investigative Site 050
🇺🇸Chicago, Illinois, United States
Forest Investigative Site 030
🇺🇸Orlando, Florida, United States
Forest Investigative Site 010
🇺🇸Albuquerque, New Mexico, United States
Forest Investigative Site 037
🇺🇸Chicago, Illinois, United States
Forest Investigative Site 019
🇺🇸Murrieta, California, United States
Forest Investigative Site 020
🇺🇸Baltimore, Maryland, United States
Forest Investigative Site 062
🇺🇸Orlando, Florida, United States
Forest Investigative Site 059
🇺🇸Bellevue, Washington, United States
Forest Investigative Site 058
🇺🇸New York City, New York, United States
Forest Investigative Site 036
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 035
🇺🇸Miami, Florida, United States
Forest Investigative Site 040
🇺🇸Indianapolis, Indiana, United States
Forest Investigative Site 061
🇺🇸Las Vegas, Nevada, United States
Forest Investigative Site 042
🇺🇸Oklahoma City, Oklahoma, United States
Forest Investigative Site 048
🇺🇸Oklahoma City, Oklahoma, United States
Forest Investigative Site 039
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 018
🇺🇸Gainsville, Florida, United States
Forest Investigative Site 066
🇺🇸Portland, Oregon, United States
Forest Investigative Site 056
🇺🇸Milwaukee, Wisconsin, United States
Forest Investigative Site 002
🇺🇸Costa Mesa, California, United States
Forest Investigative Site 003
🇺🇸Redlands, California, United States
Forest Investigative Site 055
🇺🇸Hallandale Beach, Florida, United States
Forest Investigative Site 038
🇺🇸Fort Myers, Florida, United States
Forest Investigative Site 032
🇺🇸West Palm Beach, Florida, United States
Forest Investigative Site 022
🇺🇸Winter Park, Florida, United States
Forest Investigative Site 045
🇺🇸Pembroke Pines, Florida, United States
Forest Investigative Site 012
🇺🇸Lafayette, Indiana, United States
Forest Investigative Site 011
🇺🇸Albuquerque, New Mexico, United States
Forest Investigative Site 053
🇺🇸Prairie Village, Kansas, United States
Forest Investigative Site 024
🇺🇸Willingboro, New Jersey, United States
Forest Investigative Site 004
🇺🇸Brooklyn, New York, United States
Forest Investigative Site 007
🇺🇸Cedarhurst, New York, United States
Forest Investigative Site 047
🇺🇸New York, New York, United States
Forest Investigative Site 049
🇺🇸Bridgeville, Pennsylvania, United States
Forest Investigative Site 064
🇺🇸Memphis, Tennessee, United States
Forest Investigative Site 013
🇺🇸Austin, Texas, United States
Forest Investigative Site 052
🇺🇸Middleton, Wisconsin, United States
Forest Investigative Site 054
🇺🇸Spokane, Washington, United States
Forest Investigative Site 043
🇺🇸Orange, California, United States
Forest Investigative Site 027
🇺🇸Fayetteville, Arkansas, United States
Forest Investigative Site 057
🇺🇸Upland, California, United States