Vortioxetine to Prevent Return of Symptoms in Children With Depressio

Phase 1

• Conditions: Major Depressive Disoder; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2010-020493-42-BG
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-25
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

De novo patients and roll over patients from studies 12709A and 12712A
• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: N/A;Primary end point(s): Time to relapse<br>Relapse defined as either a total score =40 on the Children Depression Rating Scale Revised Version (CDRS-R) total score with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician;Timepoint(s) of evaluation of this end point: Baseline/Randomization to week 26 in the double-blind treatment period