Last updated on June 2020

Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years With Major Depressive Disorder (MDD)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Major depression
  • Age: Between 7 - 11 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. The patient has Major depressive disorder (MDD), diagnosed according to DSM-5.
  2. The patient has a CDRS-R total score 45 at the Screening Visit and the Baseline.
  3. The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score 4 at the Screening Visit and the Baseline.
  4. The patient is a boy or girl, aged 7 and <12 years at Screening Visit
  5. The patient has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.

Exclusion Criteria:

  1. The patient has participated in a clinical study <30 days prior to the Screening Visit.
  2. The patient has previously participated in a study with vortioxetine.

Other protocol defined inclusion and exclusion criteria may apply

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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