A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-17
SponsorTakeda
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
The participant has previously been entered and moved to Phase A in this trial.
The participant has participated in a clinical trial less than 30 days before the Screening Visit.
The participant is a member of the trial personnel or of their immediate families or is a subordinate (or immediate family member of a subordinate) to any of the trial personnel.
The participant has been previously treated with vortioxetine.
Trial design
Treatments tested in this trial
- Vortioxetine tablets
- Placebo tablets
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov