A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-23)

• 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: Forest Laboratories
• Information provided by (Responsible Party): Forest Laboratories

Tracking Information

• First Submitted Date: April 28, 2015
• First Posted Date: May 6, 2015
• Results First Submitted Date: July 23, 2019
• Results First Posted Date: September 11, 2019
• Last Update Posted Date: September 11, 2019
• Actual Study Start Date: May 2, 2015
• Actual Primary Completion Date: July 23, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: May 1, 2015): Number of patients to experience a Treatment Emergent Adverse Event (TEAE) [ Time Frame: Baseline to Week 26 ]

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Major Depressive Disorder

Intervention

Drug: Vilazodone

Vilazodone tablets, once daily, oral administration

Other Name: Viibryd

Study Arms

Experimental: Vilazodone

Intervention: Drug: Vilazodone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 10, 2019): 330
• Original Estimated Enrollment (submitted: May 1, 2015): 250
• Actual Study Completion Date: July 23, 2018
• Actual Primary Completion Date: July 23, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 7 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT02436239
• Other Study ID Numbers: VLZ-MD-23
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Forest Laboratories
• Study Sponsor: Forest Laboratories
• Collaborators: Not Provided

Investigators

• Study Director: Emily McCusker, PhD; Forest Research Institute, Inc., an affiliate of Allergan, plc

• PRS Account: Forest Laboratories
• Verification Date: September 2019