Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder (VLZ-MD-21)
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|ClinicalTrials.gov Identifier: NCT01878292|
Recruitment Status : Completed
First Posted : June 14, 2013
Results First Posted : December 24, 2019
Last Update Posted : December 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Placebo Drug: Vilazodone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||529 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder|
|Actual Study Start Date :||July 11, 2013|
|Actual Primary Completion Date :||March 17, 2016|
|Actual Study Completion Date :||October 5, 2016|
Placebo Comparator: Placebo
Dose-matched placebo tablets, once per day, oral administration
Dose matched placebo tablets, once per day, oral administration.
Experimental: Vilazodone 15 mg
15 mg vilazodone tablets, once per day, oral administration
Vilazodone tablets, 15 mg per day, oral administration
Other Name: Viibryd
Experimental: vilazodone 30 mg
30 mg vilazodone tablets, once per day, oral administration
Vilazodone tablets, 30 mg once per day, oral administration
Other Name: Viibryd
- Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score [ Time Frame: From Baseline to week 8 ]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 in Clinical Global Impressions-Severity (CGI-S) Score [ Time Frame: From Baseline to Week 8 ]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.
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): NCT01878292
|Study Director:||Chandran Prakash||Allergan|