Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
H. Lundbeck A/S
With
Takeda
Age
12–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
The patient is a male or female, aged ≥12 and ≤17 years at Screening (patients who turn 18 years during the study will be allowed to continue in the study).
The patient has Major depressive disorder (MDD), diagnosed according to DSM-5™.
The patient has a Children Depression Rating Scale - Revised (CDRS-R) total score ≥45 at the Screening Visit and at the Baseline.
The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≥4 at the Screening Visit and at the Baseline
The patient has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.
You may not be if
The patient has participated in a clinical study \<30 days prior to the Screening Visit.
Clareo Health | Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)
