Vortioxetine to Prevent Return of Symptoms in Children With Depression

• Status: Recruiting
• Trial end date: 2023-12-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out if vortioxetine is better than placebo (sugar pills) in preventing depression in children who improved when treated with vortioxetine.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Vortioxetine

Criteria

Inclusion Criteria:

De novo patients

• The patient has a primary diagnosis of MDD according to DSM-5™ although co-morbid anxiety disorders will be permitted (except Post Traumatic Stress Disorder (PTSD) and Obsessive Compulsive Disorder (OCD)).

• The patient has a CDRS-R total score ≥45 at the Screening and Baseline Visits.

• The patient has a Clinical Global Impression - Severity of Illness (CGI-S) ≥4 at the Screening and Baseline Visit

Exclusion Criteria:

• The patient receives ongoing current psychotherapy that is planned to be intensified. Interpersonal psychotherapy (IPT) or cognitive behavioural therapy (CBT) are not allowed.

• The patient presents with, or has a history of, an Axis I (DSM-5TM) diagnosis of Bipolar Disorder, PTSD, OCD, Autism, Pervasive Developmental Disorder (PDD), or Schizophrenia or Schizoaffective Disorder.

• The patient has a diagnosis of attention-deficit/hyperactivity disorder (ADHD) and is not maintained on a stable dose of a methylphenidate or amphetamine for a minimum of 4 weeks prior to the study treatment.

• The patient has attempted suicide or is at significant risk of suicide

Other inclusion and exclusion criteria may apply.