A study to evaluate the effect of a product named vortioxetine (used in depression) in children. These effects will be compared to those induced by a marketed comparator and a placebo. Investigator and subjects will be blinded.

Phase 1

• Conditions: Major Depressive Disorder; MedDRA version: 19.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2008-005353-38-FR
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-03
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

- The patient is a boy or girl, aged =7 and <12 years at screening (patients who turn 12 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 CDRS-R total score =45 at the Screening Visit and the Baseline Visit.
- The patient has a CGI-S score =4 at the Screening Visit and the Baseline Visit.
- The patient has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.

Are the trial subjects under 18? yes
Number of subjects for this age range: 750
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

- The patient has participated in a clinical study <30 days prior to the Screening Visit.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in children with a DSM-5™ diagnosis of MDD.;Secondary Objective: To evaluate the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on:<br>- global clinical impression<br>- functionality <br>- health-related quality of life <br><br>To assess pharmacokinetics of vortioxetine in paediatric patients, aged 7 to 11 years using population pharmacokinetic approach<br><br>Exploratory objectives:<br>- to explore the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on co-morbid symptoms<br><br>Safety objectives:<br>- to evaluate the safety and tolerability of vortioxetine 10 mg/day and 20 mg/day versus placebo in children with a DSM-5™ diagnosis of MDD <br>;Primary end point(s): Change in Children Depression Rating Scale - Revised (CDRS-R) total score after treatment;Timepoint(s) of evaluation of this end point: Throughout the study