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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
330
Vilazodone tablets, once daily, oral administration
Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE)
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
Time frame: Visit 1 (Week -1) to up to Visit 16 (Week 26)
Change From Baseline in the CDRS-R Total Score
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.
Time frame: Baseline (Week 0) to Week 26
Change From Baseline in the CGI-S Score
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.
Time frame: Baseline (Week 0) to Week 26
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I)
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.
Time frame: Baseline (Week 0) to Week 26
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Alliance Clinical Research
Birmingham, Alabama, United States
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Dothan, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Woodland International Research Group, INC
Little Rock, Arkansas, United States
CITrials - Bellflower
Bellflower, California, United States
ATP Clinical Research
Costa Mesa, California, United States
Behavioral Research Specialists, LLC
Glendale, California, United States
PCSD - Feighner Research
San Diego, California, United States
Pacific Clinical Research Medical Group
Hartford, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
...and 46 more locations