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Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vortioxetine
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring children, adolescent

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient is a male or female child aged ≥7 and <12 years or an adolescent aged ≥12 and ≤17 years at Baseline in Study 12712B.
  • The patient must have completed extension Study 12712A immediately prior to enrolment into this extension study.
  • The patient had a primary diagnosis of a MDD at entry in Study 12709A or 12710A, diagnosed according to DSM-5™.
  • The patient is still indicated for long-term treatment with vortioxetine according to the clinical opinion of the investigator.

Exclusion Criteria:

  • The patient has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12712A.
  • The patient has an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication.

Other protocol-defined inclusion and exclusion criteria may apply

Sites / Locations

  • MHAT "Targovishte" AD
  • DCC Mladost-M
  • Marienthal Center of Psychiatry and Psychology
  • CHU de Nantes - Hopital Hotel Dieu
  • Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri
  • Vadaskert Alapitvany
  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  • Scientific Institute Fondazione Stella Maris
  • Universita degli Studi di Messina - Facolta di Medicina e Chirurgia
  • Linda Keruze's Psychiatric Center, LLC
  • Prywatne Gabinety Lekarskie ¿Promedicus¿ Anna Agnieszka Tomczak
  • Centrum Badan Klinicznych PI-House Sp. z o.o.
  • Przychodnia Syntonia Poradnia Zdrowia Psychicznego
  • SPECTRUM Centrum Neurologii i Psychiatrii
  • Filip Rybakowski Specjalistyczna Praktyka Lekarska
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej (SPZOZ) - Centrum Neuropsychiatrii "NEUROMED"
  • State Budgetary Healthcare Institution of Sverdlovsk Region
  • Specialized Clinical Psychiatric Hospital 1 of the Ministry of Health
  • Lipetsk Regional Psychoneurological Hospital
  • Nizhny Novgorod Region State Institution Of Healthcare
  • Medicorehabilitation Research Center "Phoenix"
  • Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
  • Guz "Saratov Regional Psychiatric Hospital St. Sofii"
  • Saratov State Medical University
  • State Budgetary Healthcare Institution
  • Clinic of Neurology and Psychiatry for Children and Adolescents
  • Clinical Center of Vojvodina - Clinic of Psychiatry
  • Cape Trial Centre
  • Hospital General Universitario Gregorio Maranon
  • Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo
  • Alder Hey Childrens Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vortioxetine

Arm Description

Once daily dosing of vortioxetine (oral tablets) for 78 weeks.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events (Safety)
Based on safety assessments (e.g. 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

Secondary Outcome Measures

Change in CDRS-R total score
Children Depression Rating Scale, revised version
Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration)
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)
Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration)
Change in CGI-S score
Clinical Global Impression - Severity of Illness
CGI-I score
Clinical Global Impression - Global Improvement
Children (7-11 years): change in BRIEF using the Global Executive Composite score
Behaviour Rating Inventory of Executive Function
Children (7-11 years): change in BRIEF using the Megacognition Index
Behaviour Rating Inventory of Executive Function
Adolescents (12-17 years): change in BRIEF-SR using the Global Executive Composite score
Behaviour Rating Inventory of Executive Function, Self-report version
Adolescents (12-17 years): change in BRIEF-SR using the Megacognition Index
Behaviour Rating Inventory of Executive Function, Self-report version
Change in CGAS score
Children's Global Assessment Scale
Change in PedsQL VAS score
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales

Full Information

First Posted
March 10, 2017
Last Updated
June 22, 2021
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT03108625
Brief Title
Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age
Official Title
Long-term, Open-label, Flexible-dose, Continuation Extension Study With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
April 16, 2020 (Actual)
Study Completion Date
April 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
children, adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vortioxetine
Arm Type
Experimental
Arm Description
Once daily dosing of vortioxetine (oral tablets) for 78 weeks.
Intervention Type
Drug
Intervention Name(s)
Vortioxetine
Other Intervention Name(s)
Brintellix, Lu AA21004
Intervention Description
Target dose is 10 mg/day; the dose can be down- or uptitrated to 5, 15, or 20 mg/day.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events (Safety)
Description
Based on safety assessments (e.g. 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
Time Frame
Up to Week 104
Secondary Outcome Measure Information:
Title
Change in CDRS-R total score
Description
Children Depression Rating Scale, revised version
Time Frame
Change from study 12712A baseline to Week 104
Title
Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration)
Description
Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration)
Time Frame
Up to Week 104
Title
Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration)
Description
Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration)
Time Frame
Up to Week 104
Title
Change in CGI-S score
Description
Clinical Global Impression - Severity of Illness
Time Frame
Change from study 12712A baseline to Week 104
Title
CGI-I score
Description
Clinical Global Impression - Global Improvement
Time Frame
Week 104
Title
Children (7-11 years): change in BRIEF using the Global Executive Composite score
Description
Behaviour Rating Inventory of Executive Function
Time Frame
Change from study 12712A baseline to Week 104
Title
Children (7-11 years): change in BRIEF using the Megacognition Index
Description
Behaviour Rating Inventory of Executive Function
Time Frame
Change from study 12712A baseline to Week 104
Title
Adolescents (12-17 years): change in BRIEF-SR using the Global Executive Composite score
Description
Behaviour Rating Inventory of Executive Function, Self-report version
Time Frame
Change from study 12712A baseline to Week 104
Title
Adolescents (12-17 years): change in BRIEF-SR using the Megacognition Index
Description
Behaviour Rating Inventory of Executive Function, Self-report version
Time Frame
Change from study 12712A baseline to Week 104
Title
Change in CGAS score
Description
Children's Global Assessment Scale
Time Frame
Change from study 12712A baseline to Week 104
Title
Change in PedsQL VAS score
Description
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales
Time Frame
Change from study 12712A baseline to Week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient is a male or female child aged ≥7 and <12 years or an adolescent aged ≥12 and ≤17 years at Baseline in Study 12712B. The patient must have completed extension Study 12712A immediately prior to enrolment into this extension study. The patient had a primary diagnosis of a MDD at entry in Study 12709A or 12710A, diagnosed according to DSM-5™. The patient is still indicated for long-term treatment with vortioxetine according to the clinical opinion of the investigator. Exclusion Criteria: The patient has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12712A. The patient has an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication. Other protocol-defined inclusion and exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
MHAT "Targovishte" AD
City
Targovishte
Country
Bulgaria
Facility Name
DCC Mladost-M
City
Varna
Country
Bulgaria
Facility Name
Marienthal Center of Psychiatry and Psychology
City
Tallinn
Country
Estonia
Facility Name
CHU de Nantes - Hopital Hotel Dieu
City
Nantes
Country
France
Facility Name
Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri
City
Mainz
Country
Germany
Facility Name
Vadaskert Alapitvany
City
Budapest
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
City
Gyula
Country
Hungary
Facility Name
Scientific Institute Fondazione Stella Maris
City
Calambrone
Country
Italy
Facility Name
Universita degli Studi di Messina - Facolta di Medicina e Chirurgia
City
Messina
Country
Italy
Facility Name
Linda Keruze's Psychiatric Center, LLC
City
Liepāja
Country
Latvia
Facility Name
Prywatne Gabinety Lekarskie ¿Promedicus¿ Anna Agnieszka Tomczak
City
Białystok
Country
Poland
Facility Name
Centrum Badan Klinicznych PI-House Sp. z o.o.
City
Gdańsk
Country
Poland
Facility Name
Przychodnia Syntonia Poradnia Zdrowia Psychicznego
City
Kielce
Country
Poland
Facility Name
SPECTRUM Centrum Neurologii i Psychiatrii
City
Lublin
Country
Poland
Facility Name
Filip Rybakowski Specjalistyczna Praktyka Lekarska
City
Poznań
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej (SPZOZ) - Centrum Neuropsychiatrii "NEUROMED"
City
Wrocław
Country
Poland
Facility Name
State Budgetary Healthcare Institution of Sverdlovsk Region
City
Ekaterinburg
Country
Russian Federation
Facility Name
Specialized Clinical Psychiatric Hospital 1 of the Ministry of Health
City
Krasnodar
Country
Russian Federation
Facility Name
Lipetsk Regional Psychoneurological Hospital
City
Lipetsk
Country
Russian Federation
Facility Name
Nizhny Novgorod Region State Institution Of Healthcare
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Medicorehabilitation Research Center "Phoenix"
City
Rostov-on-Don
Country
Russian Federation
Facility Name
Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
City
Rostov-on-Don
Country
Russian Federation
Facility Name
Guz "Saratov Regional Psychiatric Hospital St. Sofii"
City
Saratov
Country
Russian Federation
Facility Name
Saratov State Medical University
City
Saratov
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution
City
Tonnel'nyy
Country
Russian Federation
Facility Name
Clinic of Neurology and Psychiatry for Children and Adolescents
City
Belgrade
Country
Serbia
Facility Name
Clinical Center of Vojvodina - Clinic of Psychiatry
City
Novi Sad
Country
Serbia
Facility Name
Cape Trial Centre
City
Bellville
Country
South Africa
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
Country
Spain
Facility Name
Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo
City
Torremolinos
Country
Spain
Facility Name
Alder Hey Childrens Hospital
City
Liverpool
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age

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