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Completed

NCT Number: NCT02436239

A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder

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).

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Okanagan Clinical Trials Inc., Kelowna, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vilazodone

Drug

Vilazodone tablets, once daily, oral administration

Other names: Viibryd

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

An Open-label Long-term Safety Study of Vilazodone in Pediatric Patients With Major Depressive Disorder

Acronym: VLZ-MD-23

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 6, 2015
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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