Vilazodone in Adolescents with Major Depression
This study is a double-blind, randomized, placebo-controlled, parallel group, fixed-dose study in adolescent patients, ages 12-17 years. The study will be 10 weeks in duration; a 1-week screening period, followed by an 8-week double-blind treatment period, and a 1-week double-blind down-taper period. The study will include a total of 9 visits.
Patients meeting eligibility criteria at the end of Visit 2 will be randomized in a ratio of 1:1:1 to one of three treatment groups: placebo, vilazodone 15 mg/day, or vilazodone 30 mg/day. Patients in all three treatment groups will participate in the one-week down-taper period, either upon completion of the study or following early termination from the study.
a total of 495 patients from 55 study centers will be enrolled in the study.
1. Patients must provide assent to participation and their legally appointed guardian (LAR) and caregiver (even if the same as the LAR) must provide written informed consent prior to the conduct of any study-specific procedures.
2. Male or female outpatients between 12-17 years of age, inclusive, at Visit 1
3. Patients must meet DSM-IV-TR criteria for MDD, confirmed by K-SADS-PL, with a minimum duration of 6 weeks at Visit 1
4. Patients must have a score of 40 or greater on the CDRS-R at Visits 1 and 2
5. Patients must have a Clinical Global Impressions-Severity (CGI-S) score of 4 or greater at Visits 1 and 2
6. Patients must have a caregiver who can and is wiling to be responsible for safety monitoring of the patients, provide information about the patient's condition, oversee the administration of investigational product and accompany the patient to all study visits
7. Normal physical examination findings, vital sign values, clinical laboratory test results and ECG results or abnormal results that are judged not clinically significant by the investigator
8. Negative serum hCG pregnancy test result in female patients