A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Sponsored by Takeda
About this trial
Last updated 24 days ago
Study ID
Vortioxetine-3023
Status
Recruiting
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
12 to 17 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Started 6 months ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
Must be a Japanese aged 12 to 17 years.
Must be capable of communicating with the trial staff.
Must be willing to accept video recording for assessment.
Must have a primary diagnosis of Major Depressive Disorder (MDD) or persistent depressive disorder and fully meet the criteria for major depressive episodes according to DSM-5-TR.
Exclusion Criteria
Cannot have participated in another clinical trial within 30 days before the screening visit.
Cannot have been previously treated with vortioxetine.
Cannot have plans environmental changes (eg, hospitalization, change of residence) during the trial.
Cannot have any other psychiatric disorder according to DSM-5-TR criteria.
Cannot have a history of substance use disorder or alcohol use disorder within 6 months before the screening visit.
Additional entry criteria will be discussed with the study doctor.