A study to evaluate the effect of a product named vortioxetine (used in depression) in adolescents. These effects will be compared to those induced by a marketed comparator and a placebo. Investigator and subjects will be blinded.
- Conditions
- Major Depressive DisorderMedDRA version: 18.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2008-005354-20-IT
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 784
- The patient is a male or female, aged =12 and =17 years at screening (patients who turn 18 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 at the Baseline Visit.
- The patient has a CGI-S score =4 at the Screening Visit and at 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
- 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 adolescents 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>- cognitive performance<br>- global clinical impression<br>- functionality <br>- health-related quality of life <br><br>To assess pharmacokinetics of vortioxetine in paediatric patients aged 12 to 17 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 adolescents 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
- Secondary Outcome Measures
Name Time Method