- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00644358
A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD)
August 22, 2017 updated by: Forest Laboratories
A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder
This open label 52-week clinical trial is designed to assess the safety and tolerability of vilazodone and to analyze genetic markers of response to vilazodone in adult patients diagnosed with MDD.
This study will enroll approximately 600 patients.
Study Overview
Detailed Description
Patients will be enrolled at approximately 40 US investigative sites and receive vilazodone for 52 weeks of open label treatment.
Safety measurements will include adverse events, vital signs, laboratory, ophthalmologic exams, Changes in Sexual Function Questionnaire (CSFQ) scale and electrocardiogram (ECG) findings collected over the course of the treatment period.
Effectiveness measurements will be done at baseline and each visit until week 52 or end-of-treatment.
A deoxyribonucleic acid (DNA) sample will be collected for genetic analysis related to response to vilazodone.
Study Type
Interventional
Enrollment (Actual)
616
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Garden Grove, California, United States, 92845
- Collaborative Neuroscience Network, Inc.
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San Diego, California, United States, 92108
- Affiliated Research Institute
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Torrance, California, United States, 90502
- Collaborative Neuroscience Network, Inc
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Upland, California, United States, 91786
- Pacific Clinical Research
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Colorado
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Denver, Colorado, United States, 80239
- Radiant Research
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Florida
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Coral Springs, Florida, United States, 33065
- CNS Clinical Research Group
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Fort Myers, Florida, United States, 33912
- Gulfcoast Clinical Research
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Gainesville, Florida, United States, 32607
- Sarkis Clinical Trials
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Jacksonville, Florida, United States, 32216
- Clinical Neuroscience Solutions, Inc
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Lady Lake, Florida, United States, 32159
- Florida Clinical Research Center, LLC
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Orlando, Florida, United States, 32806
- Clinical Neuroscience Solutions, PA
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Tampa, Florida, United States, 33613
- Stedman Clinical Trials
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Georgia
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Smyrna, Georgia, United States, 30080
- Carman Research
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Illinois
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Chicago, Illinois, United States, 60634
- Chicago Research Center
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Libertyville, Illinois, United States, 60048
- Capstone Clinical Research
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Indiana
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Indianapolis, Indiana, United States, 46260
- Davis Clinic
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Kansas
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Overland Park, Kansas, United States, 66212
- Vince and Associates Clinical Research
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Maryland
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Rockville, Maryland, United States, 20852
- Capital Clinical Research Associates
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Michigan
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Farmington, Michigan, United States, 48336
- Summit Research Network
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Missouri
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Saint Louis, Missouri, United States, 63141
- Radiant Research
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Nevada
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Las Vegas, Nevada, United States, 89146
- Radiant Research
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New York
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Mount Kisco, New York, United States, 10549
- Bioscience Research, LLC
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New York, New York, United States, 10021
- Eastside Comprehensive Medical Center
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New York, New York, United States, 10024
- The Medical Research Network, LLC
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Ohio
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Beachwood, Ohio, United States, 44122
- North Coast Clinical Trials
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Cincinnati, Ohio, United States, 45242
- Patient Priority Clinical Sites, LLC
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Middleburg Heights, Ohio, United States, 44130
- North Star Medical Research, LLC
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- IPS Research Company
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Pennsylvania
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Bridgeville, Pennsylvania, United States, 15017
- Paramount Clinical Research
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Colmar, Pennsylvania, United States, 18915
- Introspect of Buxmont
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Media, Pennsylvania, United States, 19063
- Suburban Research Associates
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Tennessee
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Memphis, Tennessee, United States, 38119
- Clinical Neuroscience Solutions
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Texas
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Austin, Texas, United States, 78756
- FutureSearch Trials
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Dallas, Texas, United States, 75231
- FutureSearch Trials
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San Antonio, Texas, United States, 78229
- Croft Group Research Center
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Vermont
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Woodstock, Vermont, United States, 05091
- Neuropsychiatric Associates
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Virginia
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Herndon, Virginia, United States, 20170
- Neuroscience, Inc.
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Midlothian, Virginia, United States, 23112
- Dominion Clinical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or females 18-70 years of age.
- 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 with a history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Vilazodone
Vilazodone titrated up to 40 mg/day for 1 year.
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titration to 40 milligrams (mg) every day (qd) for 1 year
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
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An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant administered study drug.
An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product.
An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of study medication or was present at, or before, the day of the first dose of study medication and increased in severity during the treatment period.
AEs included abnormal clinically significant findings for laboratory parameters, physical examinations, vital signs, weight, electrocardiograms (ECGs), the Change in Sexual Functioning Questionnaire (CSFQ), ophthalmologic exams and the Columbia-Suicide Severity Rating Scale (C-SSRS).
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From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score
Time Frame: Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination
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The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview.
Participants 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.
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Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination
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Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score
Time Frame: Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination
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The CGI-S is a clinician-rated scale that measures global severity of illness at a given point in time using a 7-point scale where 1=normal, not at all ill, and 7=among the most severely ill.
A negative change from Baseline indicates improvement.
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Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination
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Clinical Global Impression - Improvement (CGI-I) Score
Time Frame: Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination
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The CGI-I is a clinician-rated scale for assessing improvement of a patient's condition, using a 7-point scale where 1=very much improved (best) and 7=very much worse.
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Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Carol R Reed, MD, Forest Laboratories
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 31, 2007
Primary Completion (ACTUAL)
May 31, 2009
Study Completion (ACTUAL)
May 31, 2009
Study Registration Dates
First Submitted
March 20, 2008
First Submitted That Met QC Criteria
March 25, 2008
First Posted (ESTIMATE)
March 26, 2008
Study Record Updates
Last Update Posted (ACTUAL)
September 25, 2017
Last Update Submitted That Met QC Criteria
August 22, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Vilazodone Hydrochloride
Other Study ID Numbers
- CLDA-07-DP-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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