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.

• Register: EUCTR
• Last refreshed on: 2 March 2022
• Main ID: EUCTR2008-005353-38-EE
• Date of registration: 09/12/2015
• Prospective Registration: Yes
• Primary sponsor: H. Lundbeck A/S
• Public title: 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.
• Scientific title: 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)
• Date of first enrolment: 18/01/2016
• Target sample size: 750
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005353-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: yes; Other: no; Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Lundbeck Clinical Trials
• Affiliation: H. Lundbeck A/S

• Name: Lundbeck Clinical Trials
• Affiliation: H. Lundbeck A/S

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Major Depressive Disorder
MedDRA version: 20.0 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders

Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Intervention(s)

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: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Brintellix 10 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: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Brintellix 15 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: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Brintellix 20 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: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Fluoxetin HEXAL 10 mg Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Fluoxetine
Other descriptive name: FLUOXETINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Fluoxetin HEXAL 10 m

Primary Outcome(s)

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

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

Timepoint(s) of evaluation of this end point: Throughout the study

Secondary Outcome(s)

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

Secondary ID(s)

12709A

2008-005353-38-LV

Source(s) of Monetary Support

H. Lundbeck A/S

Ethics review

Status: Approved
Approval date: 12/01/2016
Contact: