A study to evaluate the long-term safety and tolerability of a product named vortioxetine (used in depression) in children and adolescents.

Long-term, open-label, flexible-dose, extension study of vortioxetine in child and adolescent patients with Major Depressive Disorder (MDD) from 7 to 18 years of age

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005356-25-IT

Enrollment

850

Registered

2016-04-20

Start date

2016-07-20

Completion date

Unknown

Last updated

2024-03-12

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: 19.0 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 male or female child aged =7 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - The patient has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A or 12710A. - The patient has an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD.;Secondary Objective: Evaluation of the long-term effectiveness of flexible doses of vortioxetine in a range of 5 mg/day to 20 mg/day on: - depressive symptoms - clinical global impression - cognitive function - functionality ;Primary end point(s): Safety: Safety evaluation based on adverse events, paediatric adverse event rating scale (PAERS), clinical safety laboratory tests (including reproductive hormones), vital signs, weight, height, Tanner score, menstrual cycle, ECG, and C-SSRS.;Timepoint(s) of evaluation of this end point: Throughout the study	—

Measure

Time frame

Main Objective: Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD.;Secondary Objective: Evaluation of the long-term effectiveness of flexible doses of vortioxetine in a range of 5 mg/day to 20 mg/day on: - depressive symptoms - clinical global impression - cognitive function - functionality ;Primary end point(s): Safety: Safety evaluation based on adverse events, paediatric adverse event rating scale (PAERS), clinical safety laboratory tests (including reproductive hormones), vital signs, weight, height, Tanner score, menstrual cycle, ECG, and C-SSRS.;Timepoint(s) of evaluation of this end point: Throughout the study

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Secondary

Measure	Time frame
Secondary end point(s): - Change in Children Depression Rating Scale - Revised version (CDRS-R) total score - Number of relapses (CDRS-R =40 with a history of 2 weeks of clinical deterioration) - Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration) - Change in Clinical Global Impression - Severity of Illness (CGI-S) score - Clinical Global Impression - Global Improvement (CGI-I) score - Children (7-11 years): Change in Behaviour Rating Inventory of Executive Function (BRIEF) using the Global Executive Composite score - Children (7-11 years): Change in BRIEF using the Metacognition Index - Adolescents (12-18 years): Change in Behaviour Rating Inventory of Executive Function - Self-report version (BRIEF-SR) using the Global Executive Composite score - Adolescents (12-18 years): Change in BRIEF-SR using the Metacognition Index - Change in Children’s Global Assessment Scale (CGAS) score - Change in in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) 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 version (CDRS-R) total score - Number of relapses (CDRS-R =40 with a history of 2 weeks of clinical deterioration) - Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration) - Change in Clinical Global Impression - Severity of Illness (CGI-S) score - Clinical Global Impression - Global Improvement (CGI-I) score - Children (7-11 years): Change in Behaviour Rating Inventory of Executive Function (BRIEF) using the Global Executive Composite score - Children (7-11 years): Change in BRIEF using the Metacognition Index - Adolescents (12-18 years): Change in Behaviour Rating Inventory of Executive Function - Self-report version (BRIEF-SR) using the Global Executive Composite score - Adolescents (12-18 years): Change in BRIEF-SR using the Metacognition Index - Change in Children’s Global Assessment Scale (CGAS) score - Change in in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) 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