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Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22) (VLZ-MD-22)

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ClinicalTrials.gov Identifier: NCT02372799
Recruitment Status : Recruiting
First Posted : February 26, 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 efficacy, safety, and tolerability of vilazodone compared with placebo in pediatric outpatients (7-17 years of age) with major depressive disorder.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Placebo- and Active-Controlled Parallel-Group Evaluation of the Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder
Actual Study Start Date : February 28, 2015
Estimated Primary Completion Date : September 8, 2018
Estimated Study Completion Date : September 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vilazodone
Vilazodone tablets, 5mg, 10mg and 20mg. Oral administration, once per day.
Drug: Vilazodone
Other Name: Viibryd

Placebo Comparator: Placebo
Dose-matched placebo tablets or capsules, oral administration, once per day.
Drug: Placebo
Active Comparator: Fluoxetine
Fluoxetine capsules, 10mg and 20 mg. Oral administration, once per day.
Drug: Fluoxetine
Other Name: Prozac




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

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


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 between 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, 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): NCT02372799


Contacts
Contact: Clinical Trial Registries Team 866-369-5227 IR-CTRegistration@allergan.com

  Show 64 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Emily McCusker, PhD Forest Research Institute, an affiliate of Allergan plc.

Additional Information:
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT02372799     History of Changes
Other Study ID Numbers: VLZ-MD-22
First Posted: February 26, 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
Fluoxetine
Vilazodone Hydrochloride
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists