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Trial record 1 of 1 for:    NCT02436239
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A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-23)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02436239
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : October 23, 2018
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

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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
Actual Primary Completion Date : July 23, 2018
Actual Study Completion Date : July 23, 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

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 identifier (NCT number): NCT02436239

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

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

Additional relevant MeSH terms:
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Depressive Disorder
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