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

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ClinicalTrials.gov Identifier: NCT02436239
Recruitment Status : Active, not recruiting
First Posted : May 6, 2015
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Vilazodone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 331 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Long-term Safety Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
Actual Study Start Date : May 2, 2015
Estimated Primary Completion Date : July 17, 2018
Estimated Study Completion Date : July 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vilazodone Drug: Vilazodone
Vilazodone tablets, once daily, oral administration
Other Name: Viibryd




Primary Outcome Measures :
  1. Number of patients to experience a Treatment Emergent Adverse Event (TEAE) [ Time Frame: Baseline to Week 26 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436239


  Show 56 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Emily McCusker, PhD Forest Research Institute, Inc., an affiliate of Allergan, plc

Additional Information:
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT02436239     History of Changes
Other Study ID Numbers: VLZ-MD-23
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Vilazodone Hydrochloride
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists