A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-23)

September 10, 2019 updated by: Forest Laboratories

An Open-label Long-term Safety Study of Vilazodone in Pediatric Patients With Major Depressive Disorder

The purpose of this study is to evaluate the long-term safety and tolerability of vilazodone for the treatment of MDD in pediatric outpatients (7-17 years).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y1Z9
        • Okanagan Clinical Trials Inc.
    • Ontario
      • Toronto, Ontario, Canada, M6J3S3
        • Paediatric Sleep Research Inc
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Alliance Clinical Research
      • Dothan, Alabama, United States, 36303
        • Harmonex Neuroscience Research
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Group, Inc
    • California
      • Bellflower, California, United States, 90706
        • CITrials - Bellflower
      • Costa Mesa, California, United States, 92626
        • ATP Clinical Research
      • Glendale, California, United States, 91206
        • Behavioral Research Specialists, LLC
      • San Diego, California, United States, 92108
        • PCSD - Feighner Research
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Pacific Clinical Research Medical Group
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Florida
      • Hialeah, Florida, United States, 33012
        • Palm Springs Research, LLC
      • Homestead, Florida, United States, 33030
        • IMIC Inc.
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc.
      • Lauderhill, Florida, United States, 33319
        • Innovative Clinical Research, Inc.
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc.
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Institute for Advanced Medical Research
      • Atlanta, Georgia, United States, 30331
        • Atlantic Center for Medical Research
      • Marietta, Georgia, United States, 30060
        • Northwest Behavioral Research Center
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Capstone Clinical Research
      • Naperville, Illinois, United States, 60563
        • Baber Research Group
      • Oak Park, Illinois, United States, 60301
        • Neuroscience Research Institute Inc.
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Psychiatric Associates
    • Louisiana
      • Lake Charles, Louisiana, United States, 70629
        • Lake Charles Clinical Trials
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Hugo W Moser Research Institute at Kennedy Krieger, Inc.
      • Baltimore, Maryland, United States, 21208
        • Pharmsite Research Inc.
      • Rockville, Maryland, United States, 20852
        • Neuroscientific Insights
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
      • Watertown, Massachusetts, United States, 02472
        • Adams Clinical Trials, LLC
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Millennium Psychiatric Associates
      • Saint Charles, Missouri, United States, 63304
        • St. Charles Psychiatric Associates - Midwest Research Group
    • New York
      • Buffalo, New York, United States, 14215
        • Erie County Medical Center/State University of New York of Buffalo Affiliate
      • Mount Kisco, New York, United States, 10549
        • Bioscience Research LLC
      • New York, New York, United States, 10022
        • Manhattan Behavioral Medicine
      • Rochester, New York, United States, 14618
        • Finger Lakes Clinical Research
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
    • Ohio
      • Avon Lake, Ohio, United States, 44012
        • Haidar Almhana Nieding LLC
      • Canton, Ohio, United States, 44718
        • Neuro-Behavioral Clinical Research, Inc
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center, Psychiatr
      • Columbus, Ohio, United States, 43210
        • Ohio State Univ. Dept of Psychiatry
      • Mason, Ohio, United States, 45040
        • Professional Psychiatric Services
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research Company
      • Oklahoma City, Oklahoma, United States, 73116
        • Cutting Edge Research Group
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Research Strategies of Memphis LLC
    • Texas
      • Austin, Texas, United States, 78759
        • BioBehavioral Research of Austin, PC
      • Houston, Texas, United States, 77054
        • UT Health Science Center at Houston
      • Houston, Texas, United States, 77079
        • Houston Endoscopy and Research Ctr
      • Plano, Texas, United States, 75093
        • Research Across America
      • San Antonio, Texas, United States, 78229
        • Focus and Balance
      • The Woodlands, Texas, United States, 77381
        • Family Psychiatry of The Woodlands
    • Utah
      • Clinton, Utah, United States, 84015
        • Ericksen Research and Development
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • UVA Center for Psychopharmacology Research in Youth
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
      • Kirkland, Washington, United States, 98033
        • Core Clinical Research

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or Female outpatients betw een 7-17 years of age
  • Primary diagnosis of major depressive disorder (MDD)
  • Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater
  • Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

Exclusion Criteria:

  • Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision based diagnosis of an Axis I disorder other than MDD that is the primary focus of treatment (de novo patients only)
  • History of suicidal behavior, or requires precaution against suicide
  • Not generally healthy medical condition
  • Seizure disorder

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vilazodone
Drug: Vilazodone
Vilazodone tablets, once daily, oral administration
Other Names:
  • Viibryd

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE)
Time Frame: Visit 1 (Week -1) to up to Visit 16 (Week 26)
The number of Participants who experienced a treatment emergent adverse events during the 27 week period from screening to the end of the open-label treatment period
Visit 1 (Week -1) to up to Visit 16 (Week 26)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the CDRS-R Total Score
Time Frame: Baseline (Week 0) to Week 26
The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.
Baseline (Week 0) to Week 26
Change From Baseline in the CGI-S Score
Time Frame: Baseline (Week 0) to Week 26
The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients.
Baseline (Week 0) to Week 26
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I)
Time Frame: Baseline (Week 0) to Week 26
The Clinical Global Impressions-Improvement is a clinician-rated instrument that was used to rate total improvement or worsening of mental illness, regardless of whether the Investigator considered it to be a result of treatment with the investigational product. The CGI-I was used to rate the patient's improvement on a scale from 1 to 7, with 1 indicating that the patient was very much improved (with a score of 4 indicating no change) and 7 indicating the patient was very much worse.
Baseline (Week 0) to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Forest Laboratories

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Emily McCusker, PhD, Forest Research Institute, Inc., an affiliate of Allergan, plc

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 23, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 23, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VLZ-MD-23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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