Safety and Efficacy of Vilazodone in Major Depressive Disorder (VLZ-MD-01)
This study is ongoing, but not recruiting participants.
Sponsor:
Forest Laboratories
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01473381
First received: November 14, 2011
Last updated: April 15, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to evaluate the efficacy, safety and tolerability of two fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: Placebo Drug: Vilazodone Drug: Citalopram |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Placebo- and Active-Controlled, Fixed-Dose Study of Vilazodone in Patients With Major Depressive Disorder |
Resource links provided by NLM:
MedlinePlus related topics:
Depression
Drug Information available for:
Citalopram hydrobromide
Citalopram
Vilazodone hydrochloride
Escitalopram oxalate
U.S. FDA Resources
Further study details as provided by Forest Laboratories:
Primary Outcome Measures:
- Montgomery-Åsberg Depression Rating Scale (MÅDRS) [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 1120 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Matching placebo capsules, oral administration
|
Drug: Placebo
Dose-matched placebo. Oral administration, once per day.
|
|
Experimental: Vilazodone 20mg
20 mg/day vilazodone tablets, oral administration
|
Drug: Vilazodone
Vilazodone 20 mg. Oral administration, once per day.
Other Name: Viibryd
|
|
Experimental: Vilazodone 40mg
40 mg/day vilazodone tablets, oral administration
|
Drug: Vilazodone
Vilazodone 40 mg. Oral administration, once per day.
Other Name: Viibryd
|
|
Active Comparator: Citalopram
Citalopram, 40 mg/day, oral administration, once daily
|
Drug: Citalopram
Citalopram 40 mg. Oral administration, once per day.
Other Name: Celexa
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473381
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Hide Study LocationsLocations
| United States, Alabama | |
| Forest Investigative Site 036 | |
| Birmingham, Alabama, United States, 35216 | |
| Forest Investigative Site 016 | |
| Dothan, Alabama, United States, 36303 | |
| United States, Arizona | |
| Forest Investigative Site 033 | |
| Scottsdale, Arizona, United States, 85254 | |
| United States, Arkansas | |
| Forest Investigative Site 027 | |
| Fayetteville, Arkansas, United States, 72703 | |
| United States, California | |
| Forest Investigative Site 029 | |
| Cerritos, California, United States, 90703 | |
| Forest Investigative Site 002 | |
| Costa Mesa, California, United States, 92626 | |
| Forest Investigative Site 019 | |
| Murrieta, California, United States, 92562 | |
| Forest Investigative Site 025 | |
| Oceanside, California, United States, 90703 | |
| Forest Investigative Site 043 | |
| Orange, California, United States, 92868 | |
| Forest Investigative Site 003 | |
| Redlands, California, United States, 92374 | |
| Forest Investigative Site 046 | |
| Sherman Oaks, California, United States, 33026 | |
| Forest Investigative Site 057 | |
| Upland, California, United States, 91786 | |
| United States, Connecticut | |
| Forest Investigative Site 034 | |
| Cromwell, Connecticut, United States, 06416 | |
| United States, Florida | |
| Forest Investigative Site 038 | |
| Fort Myers, Florida, United States, 33912 | |
| Forest Investigative Site 018 | |
| Gainsville, Florida, United States, 32607 | |
| Forest Investigative Site 055 | |
| Hallandale Beach, Florida, United States, 33003 | |
| Forest Investigative Site 063 | |
| Jacksonville, Florida, United States, 32256 | |
| Forest Investigative Site 035 | |
| Miami, Florida, United States, 33134 | |
| Forest Investigative Site 030 | |
| Orlando, Florida, United States, 32806 | |
| Forest Investigative Site 062 | |
| Orlando, Florida, United States, 32806 | |
| Forest Investigative Site 045 | |
| Pembroke Pines, Florida, United States, 33026 | |
| Forest Investigative Site 051 | |
| Tampa, Florida, United States, 33613 | |
| Forest Investigative Site 032 | |
| West Palm Beach, Florida, United States, 33407 | |
| Forest Investigative Site 022 | |
| Winter Park, Florida, United States, 32789 | |
| United States, Georgia | |
| Forest Investigative Site 060 | |
| Atlanta, Georgia, United States, 30328 | |
| United States, Illinois | |
| Forest Investigative Site 037 | |
| Chicago, Illinois, United States, 60634 | |
| Forest Investigative Site 050 | |
| Chicago, Illinois, United States, 60640 | |
| United States, Indiana | |
| Forest Investigative Site 040 | |
| Indianapolis, Indiana, United States, 46260 | |
| Forest Investigative Site 012 | |
| Lafayette, Indiana, United States, 47905 | |
| United States, Kansas | |
| Forest Investigative Site 053 | |
| Prairie Village, Kansas, United States, 66206 | |
| United States, Maryland | |
| Forest Investigative Site 020 | |
| Baltimore, Maryland, United States, 21208 | |
| United States, Massachusetts | |
| Forest Investigative Site 031 | |
| Boston, Massachusetts, United States, 02135 | |
| United States, Nevada | |
| Forest Investigative Site 061 | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Jersey | |
| Forest Investigative Site 024 | |
| Willingboro, New Jersey, United States, 08046 | |
| United States, New Mexico | |
| Forest Investigative Site 010 | |
| Albuquerque, New Mexico, United States, 87109 | |
| Forest Investigative Site 011 | |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| Forest Investigative Site 004 | |
| Brooklyn, New York, United States, 11214 | |
| Forest Investigative Site 007 | |
| Cedarhurst, New York, United States, 11516 | |
| Forest Investigative Site 047 | |
| New York, New York, United States, 10021 | |
| Forest Investigative Site 058 | |
| New York City, New York, United States, 10003 | |
| United States, Ohio | |
| Forest Investigative Site 039 | |
| Cincinnati, Ohio, United States, 45227 | |
| United States, Oklahoma | |
| Forest Investigative Site 042 | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Forest Investigative Site 048 | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
| Forest Investigative Site 066 | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Forest Investigative Site 014 | |
| Allentown, Pennsylvania, United States, 18104 | |
| Forest Investigative Site 049 | |
| Bridgeville, Pennsylvania, United States, 15017 | |
| United States, Tennessee | |
| Forest Investigative Site 064 | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Forest Investigative Site 013 | |
| Austin, Texas, United States, 78731 | |
| Forest Investigative Site 021 | |
| Dallas, Texas, United States, 75230 | |
| United States, Washington | |
| Forest Investigative Site 059 | |
| Bellevue, Washington, United States, 98007 | |
| Forest Investigative Site 065 | |
| Seattle, Washington, United States, 98104 | |
| Forest Investigative Site 054 | |
| Spokane, Washington, United States, 99204 | |
| United States, Wisconsin | |
| Forest Investigative Site 052 | |
| Middleton, Wisconsin, United States, 53562 | |
| Forest Investigative Site 056 | |
| Milwaukee, Wisconsin, United States, 53223 | |
Sponsors and Collaborators
Forest Laboratories
Investigators
| Study Director: | Carl Gommoll, MS | Forest Laboratories |
More Information
No publications provided
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT01473381 History of Changes |
| Other Study ID Numbers: | VLZ-MD-01 |
| Study First Received: | November 14, 2011 |
| Last Updated: | April 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Forest Laboratories:
|
Major Depressive Disorder Depression |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Citalopram Dexetimide Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on May 16, 2013