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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644358
• Other study ID #: CLDA-07-DP-04
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2008
• Last updated: August 22, 2017
• Start date: December 31, 2007
• Est. completion date: May 31, 2009

Study information

• Verified date: August 2017
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 616
• Est. completion date: May 31, 2009
• Est. primary completion date: May 31, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• vilazodone
titration to 40 milligrams (mg) every day (qd) for 1 year

Locations

Country	Name	City	State
United States	FutureSearch Trials	Austin	Texas
United States	North Coast Clinical Trials	Beachwood	Ohio
United States	Paramount Clinical Research	Bridgeville	Pennsylvania
United States	Chicago Research Center	Chicago	Illinois
United States	Patient Priority Clinical Sites, LLC	Cincinnati	Ohio
United States	Introspect of Buxmont	Colmar	Pennsylvania
United States	CNS Clinical Research Group	Coral Springs	Florida
United States	FutureSearch Trials	Dallas	Texas
United States	Radiant Research	Denver	Colorado
United States	Summit Research Network	Farmington	Michigan
United States	Gulfcoast Clinical Research	Fort Myers	Florida
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Collaborative Neuroscience Network, Inc.	Garden Grove	California
United States	Neuroscience, Inc.	Herndon	Virginia
United States	Davis Clinic	Indianapolis	Indiana
United States	Clinical Neuroscience Solutions, Inc	Jacksonville	Florida
United States	Florida Clinical Research Center, LLC	Lady Lake	Florida
United States	Radiant Research	Las Vegas	Nevada
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Suburban Research Associates	Media	Pennsylvania
United States	Clinical Neuroscience Solutions	Memphis	Tennessee
United States	North Star Medical Research, LLC	Middleburg Heights	Ohio
United States	Dominion Clinical Research	Midlothian	Virginia
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	IPS Research Company	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, PA	Orlando	Florida
United States	Vince and Associates Clinical Research	Overland Park	Kansas
United States	Capital Clinical Research Associates	Rockville	Maryland
United States	Radiant Research	Saint Louis	Missouri
United States	Croft Group Research Center	San Antonio	Texas
United States	Affiliated Research Institute	San Diego	California
United States	Carman Research	Smyrna	Georgia
United States	Stedman Clinical Trials	Tampa	Florida
United States	Collaborative Neuroscience Network, Inc	Torrance	California
United States	Pacific Clinical Research	Upland	California
United States	Neuropsychiatric Associates	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	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).	From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Secondary	Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score	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.	Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination
Secondary	Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score	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.	Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination
Secondary	Clinical Global Impression - Improvement (CGI-I) Score	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.	Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination