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
7–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. The participant has MDD, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5™).
2. The participant has a CDRS-R total score ≥45 at the Screening Visit and the Baseline.
3. The participant has a CGI-S score ≥4 at the Screening Visit and the Baseline.
4. The participant is a boy or girl, aged ≥7 and \<12 years at Screening Visit
5. The participant has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.
You may not be if
1. The participant has participated in a clinical study \<30 days prior to the Screening Visit.
2. The participant has previously participated in a study with vortioxetine.
Clareo Health | Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)
