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Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder (VLZ-MD-21)

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.
 
ClinicalTrials.gov Identifier: NCT01878292
Recruitment Status : Completed
First Posted : June 14, 2013
Results First Posted : December 24, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in adolescent outpatients (12-17) with major depressive disorder.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 529 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
Actual Study Start Date : July 11, 2013
Actual Primary Completion Date : March 17, 2016
Actual Study Completion Date : October 5, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Dose-matched placebo tablets, once per day, oral administration
Drug: Placebo
Dose matched placebo tablets, once per day, oral administration.

Experimental: Vilazodone 15 mg
15 mg vilazodone tablets, once per day, oral administration
Drug: Vilazodone
Vilazodone tablets, 15 mg per day, oral administration
Other Name: Viibryd

Experimental: vilazodone 30 mg
30 mg vilazodone tablets, once per day, oral administration
Drug: Vilazodone
Vilazodone tablets, 30 mg once per day, oral administration
Other Name: Viibryd




Primary Outcome Measures :
  1. Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score [ Time Frame: From Baseline to week 8 ]
    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.


Secondary Outcome Measures :
  1. Change in Clinical Global Impressions-Severity (CGI-S) Score [ Time Frame: From Baseline to Week 8 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female outpatients between 12-17 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, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder other than major depressive disorder (MDD) that is the primary focus of treatment.
  • 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): NCT01878292


Locations
Show Show 52 study locations
Sponsors and Collaborators
Forest Laboratories
Investigators
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Study Director: Chandran Prakash Allergan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01878292    
Other Study ID Numbers: VLZ-MD-21
First Posted: June 14, 2013    Key Record Dates
Results First Posted: December 24, 2019
Last Update Posted: December 24, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
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