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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

Tracking Information
First Submitted Date  ICMJE April 28, 2015
First Posted Date  ICMJE May 6, 2015
Results First Submitted Date  ICMJE July 23, 2019
Results First Posted Date  ICMJE September 11, 2019
Last Update Posted Date September 11, 2019
Actual Study Start Date  ICMJE May 2, 2015
Actual Primary Completion Date July 23, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2015)
Number of patients to experience a Treatment Emergent Adverse Event (TEAE) [ Time Frame: Baseline to Week 26 ]
Change History Complete list of historical versions of study NCT02436239 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
Official Title  ICMJE An Open-label Long-term Safety Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: Vilazodone
Vilazodone tablets, once daily, oral administration
Other Name: Viibryd
Study Arms  ICMJE Experimental: Vilazodone
Intervention: Drug: Vilazodone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2019)
330
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2015)
250
Actual Study Completion Date  ICMJE July 23, 2018
Actual Primary Completion Date July 23, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02436239
Other Study ID Numbers  ICMJE VLZ-MD-23
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Forest Laboratories
Study Sponsor  ICMJE Forest Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Emily McCusker, PhD Forest Research Institute, Inc., an affiliate of Allergan, plc
PRS Account Forest Laboratories
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP