A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD)

Completed · Phase 3

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00644358

Run by

Forest Laboratories

People needed

616

Starts

2007-12-31

Expected to finish

2009-05-31

Last updated by the study team

2017-09-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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