Major Depressive Disorder MedDRA version: 19.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Brintellix 5 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VORTIOXETINE
CAS Number: 508233-74-7
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - The patient has participated in a clinical study <30 days prior to the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Primary end point(s): Change in Children Depression Rating Scale - Revised (CDRS-R) total score after treatment; Secondary Objective: To evaluate the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on: - cognitive performance - global clinical impression - functionality - health-related quality of life To assess pharmacokinetics of vortioxetine in paediatric patients aged 12 to 17 years using population pharmacokinetic approach Exploratory objectives: - to explore the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on co-morbid symptoms Safety objectives: - 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 ;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in Children Depression Rating Scale - Revised (CDRS-R) total score during treatment - CDRS-R response (defined as >50% reduction in the CDRS-R total score (subtracted 17 points)) - Remission (defined as CDRS-R <28), at each visit assessed - Change in General Behavior Inventory (GBI), using the 10-item depression subscale - Change in Parent Global Assessment - global Improvement (PGA) score - Change in The Symbol Digit Modalities Test (SDMT) (number of correct numbers) - Change in Clinical Global Impression - Severity of Illness (CGI-S) score - Change in Clinical Global Impression - Global Improvement (CGI-I) score - Remission in the CGI-S score (defined as a CGI-S score of 1or 2) at each visit assessed - Response in the CGI-I score (defined as a CGI-I score of 1or 2) - Change in Children's Global Assessment Scale (CGAS) score - Change in PedsQL Present Functioning Visual Analogue Scales (PedsQL VAS) score - Change in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) score ;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Countries
Austria, Belgium, Bulgaria, Canada, Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Mexico, Netherlands, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Ukraine, United Kingdom, United States
Contacts
Public ContactLundbeck Clinical Trials
H. Lundbeck A/S
Outcome results
None listed