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
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Vilazodone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||330 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Vilazodone tablets, once daily, oral administration
Other Name: Viibryd
- 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
- 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.
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
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|Study Director:||Emily McCusker, PhD||Forest Research Institute, Inc., an affiliate of Allergan, plc|