A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD)
NCT ID: NCT00644358
Last Updated: 2017-09-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
616 participants
INTERVENTIONAL
2007-12-31
2009-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vilazodone
Vilazodone titrated up to 40 mg/day for 1 year.
vilazodone
titration to 40 milligrams (mg) every day (qd) for 1 year
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
vilazodone
titration to 40 milligrams (mg) every day (qd) for 1 year
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder.
* Hamilton Depression Rating Scale (HAM-D) score ≥ 18 on the first 17 items of the 21-item HAM-D at Screening and Baseline Visits.
* Patients must have general ocular health.
Exclusion Criteria
* Patients who meet DSM-IV-TR criteria for substance abuse or dependence within 1 year of the Baseline visit.
* Patients who, in the Investigator's judgment, pose a serious suicidal or homicidal risk or have made a suicide attempt within 6 months prior to Screening Visit.
* Patients who are taking psychotropic drugs. Patients who have taken psychotropic drugs must have discontinued these prior to Screening Visit.
* Patients taking migraine medications with a serotonergic mechanism of action.
* Patients taking Cytochrome P450 3A4 (CYP3A4) inhibitors such as grapefruit juice, ketoconazole, diltiazem, and macrolide antibiotics.
* Patients with a known hypersensitivity to selective serotonin reuptake inhibitors (SSRIs) or 5-hydroxytryptamine 1a (5-HT1a) agonists.
* Patients previously treated with vilazodone.
* Patients taking Chantix or St. John's Wort.
* Presence of significant acute or chronic medical disorders by history or physical exam.
* Patients with a history of seizure disorders.
* Prior history of malignancy if patient has \<5 year survival OR completed treatment \<1 year prior to enrollment and is currently without evidence of recurrence.
* Skin cancers other than malignant melanoma will be permitted.
* Patients with evidence of other central nervous system disorders including psychosis, delirium, dementia and amnesic disorders.
* Patients with renal impairment or hepatic impairment.
* Patients who are not euthyroid.
* Patients with any serious medical or neurological disorder or condition that make it unlikely that the patient could complete one year of treatment or would otherwise preclude the administration of study medication.
* Female patients must not be pregnant, not lactating, and not planning to become pregnant during the time of study participation. All female patients who are not at least 1 year post menopausal or irreversibly surgically sterilized must be using adequate and reliable contraception throughout the trial.
* Patients with clinically significant ECG abnormalities which, as determined by the investigator, make it unlikely that the patient would complete one year of treatment or would otherwise preclude treatment with vilazodone.
* Patients having clinically significant abnormal laboratory findings.
* Patients with a positive drug screen.
* Patients who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures.
* Patients that have taken an investigational drug or participated in an investigational drug trial within the past 30 days.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Forest Laboratories
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carol R Reed, MD
Role: STUDY_DIRECTOR
Forest Laboratories
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States
Affiliated Research Institute
San Diego, California, United States
Collaborative Neuroscience Network, Inc
Torrance, California, United States
Pacific Clinical Research
Upland, California, United States
Radiant Research
Denver, Colorado, United States
CNS Clinical Research Group
Coral Springs, Florida, United States
Gulfcoast Clinical Research
Fort Myers, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, United States
Florida Clinical Research Center, LLC
Lady Lake, Florida, United States
Clinical Neuroscience Solutions, PA
Orlando, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Carman Research
Smyrna, Georgia, United States
Chicago Research Center
Chicago, Illinois, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Davis Clinic
Indianapolis, Indiana, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Capital Clinical Research Associates
Rockville, Maryland, United States
Summit Research Network
Farmington, Michigan, United States
Radiant Research
St Louis, Missouri, United States
Radiant Research
Las Vegas, Nevada, United States
Bioscience Research, LLC
Mount Kisco, New York, United States
Eastside Comprehensive Medical Center
New York, New York, United States
The Medical Research Network, LLC
New York, New York, United States
North Coast Clinical Trials
Beachwood, Ohio, United States
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Paramount Clinical Research
Bridgeville, Pennsylvania, United States
Introspect of Buxmont
Colmar, Pennsylvania, United States
Suburban Research Associates
Media, Pennsylvania, United States
Clinical Neuroscience Solutions
Memphis, Tennessee, United States
FutureSearch Trials
Austin, Texas, United States
FutureSearch Trials
Dallas, Texas, United States
Croft Group Research Center
San Antonio, Texas, United States
Neuropsychiatric Associates
Woodstock, Vermont, United States
Neuroscience, Inc.
Herndon, Virginia, United States
Dominion Clinical Research
Midlothian, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jain R, Chen D, Edwards J, Mathews M. Early and sustained improvement with vilazodone in adult patients with major depressive disorder: post hoc analyses of two phase III trials. Curr Med Res Opin. 2014 Feb;30(2):263-70. doi: 10.1185/03007995.2013.855188. Epub 2013 Oct 31.
Clayton AH, Kennedy SH, Edwards JB, Gallipoli S, Reed CR. The effect of vilazodone on sexual function during the treatment of major depressive disorder. J Sex Med. 2013 Oct;10(10):2465-76. doi: 10.1111/jsm.12004. Epub 2012 Dec 6.
Reed CR, Kajdasz DK, Whalen H, Athanasiou MC, Gallipoli S, Thase ME. The efficacy profile of vilazodone, a novel antidepressant for the treatment of major depressive disorder. Curr Med Res Opin. 2012 Jan;28(1):27-39. doi: 10.1185/03007995.2011.628303. Epub 2011 Nov 23.
Robinson DS, Kajdasz DK, Gallipoli S, Whalen H, Wamil A, Reed CR. A 1-year, open-label study assessing the safety and tolerability of vilazodone in patients with major depressive disorder. J Clin Psychopharmacol. 2011 Oct;31(5):643-6. doi: 10.1097/JCP.0b013e31822c6741.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLDA-07-DP-04
Identifier Type: -
Identifier Source: org_study_id