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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)

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ClinicalTrials.gov Identifier: NCT02436239
Recruitment Status : Completed
First Posted : May 6, 2015
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: N/A
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

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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Forest Laboratories
Investigators
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Study Director: Emily McCusker, PhD Forest Research Institute, Inc., an affiliate of Allergan, plc
  Study Documents (Full-Text)

Documents provided by Forest Laboratories:
Study Protocol  [PDF] November 2, 2016
Statistical Analysis Plan  [PDF] February 10, 2016

More Information
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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT02436239    
Other Study ID Numbers: VLZ-MD-23
First Posted: May 6, 2015    Key Record Dates
Results First Posted: September 11, 2019
Last Update Posted: September 11, 2019
Last Verified: September 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