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.

Interventional, randomised, double-blind, placebo-controlled, active reference (fluoxetine), fixed-dose study of vortioxetine in paediatric patients aged 7 to 11 years, with Major depressive disorder (MDD)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005353-38-LV

Enrollment

750

Registered

2015-11-25

Start date

2016-04-11

Completion date

Unknown

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder MedDRA version: 19.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: Brintellix 5 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: VORTIOXETINE CAS Number: 508233-74-7 Current Sponsor code: Lu AA21004 Concentration unit: m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - The patient is a boy or girl, aged =7 and =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 children with a DSM-5™ diagnosis of MDD.;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 Objective: To evaluate the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on: - global clinical impression - functionality - health-related quality of life To assess pharmacokinetics of vortioxetine in paediatric patients, aged 7 to 11 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 children with a DSM-5™ diagnosis of MDD	—

Measure

Time frame

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.;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 Objective: To evaluate the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on: - global clinical impression - functionality - health-related quality of life To assess pharmacokinetics of vortioxetine in paediatric patients, aged 7 to 11 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 children with a DSM-5™ diagnosis of MDD

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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 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	—

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 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

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Countries

Austria, Belgium, Bulgaria, Canada, Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Mexico, Netherlands, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Ukraine, United Kingdom, United States

Contacts

Public ContactLundbeck Clinical Trials

H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com+4536 3013 11

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026