A Randomized, Double-blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once-Daily Oral Administration of Vortioxetine in Japanese Pediatric Patients 12 to 17 Years of Age With Major Depressive Disorder (MDD)
The main aim of the study is to check how well vortioxetine 10 mg/day or 20 mg/day works and to check for side effects compared to a placebo on depression symptoms in Japanese teenagers aged 12 to 17 years with a diagnosis of Major Depressive Disorder (MDD). The overall time each participant will be in the study is about 20 weeks. This includes up to 15 days (about 2 weeks) to check who can take part, a 14-week period where everyone receives vortioxetine or a placebo, and after that, a 4-week period to check for any side effects after treatment. During the study, participants will visit their clinic 13 times.
• The Japanese participant is a male or female, aged 12 to 17 years at the time of informed consent (patients who turn 18 years during the trial will be allowed to continue in the trial).
• The participant is capable of communicating with the site personnel.
• The participant is able to understand the informed assent form or the ICF and parent(s)/legal guardian(s) are able to read and understand the ICF. The participant is able and willing to accept video recording at the assessment by the trial site and evaluation by third party evaluators (Central Evaluating Committee).
• The participant has provided the written informed assent as much as possible to participation and parent(s)/legal guardian(s) signed the ICF.
• The participant and parent(s)/legal guardian(s) are willing and able to attend trial appointments within the specified time windows.
• The participant is an outpatient consulting a clinician.
• The participant has a primary diagnosis of MDD or persistent depressive disorder and fully meet the criteria for major depressive episodes according to DSM-5-TR without psychotic features although co-morbid anxiety disorders will be permitted. The diagnoses will be confirmed using the MINI-KID.
• The participant has a CDRS-R total score greater than or equal to 45 at the Screening Visit and at the Baseline A Visit (Week 0).
• The participant has a CGI-S score greater than or equal to4 at the Screening Visit and at the Baseline A Visit (Week 0).
⁃ The participant has a PHQ-A score of greater than or equal to10 at the Baseline A Visit (Week 0).
⁃ The participant, if a female and is capable of producing viable ova, agrees to the following, for the period from the signing of ICF until 30 days after the last dose of trial intervention.
∙ To use a highly effective or acceptable contraceptive method
‣ To avoid donating ova
⁃ The participant, if a female, must have a confirmed negative urine pregnancy test at the Screening Visit