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Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age

Primary Purpose

Depressive Disorder, Major

Status
Terminated
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 adolescent, children

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The participant is a male or female child aged ≥7 and <12 years or adolescent aged ≥12 and ≤18 years in the lead-in study (12709A and 12710A).
  • The participant must have completed Study 12709A or 12710A (Visit 12, Completion Visit) immediately prior to enrolment into this extension study.
  • The participant had a primary diagnosis of MDD at entry in study 12709A or 12710A, diagnosed according to DSM-5™.
  • The participant is indicated for long-term treatment with vortioxetine according to the clinical opinion of the Investigator.
  • For participants aged ≥7 and ≤17 years at the Baseline visit; the participant is able to understand the Informed Assent Form, and parent(s)/legal representative(s) are able to read and understand the Informed Consent Form.
  • For participants who turned 18 years during the lead-in study 12710A; the participant has signed the Informed Consent Form.

Exclusion Criteria:

  • The participant has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A or 12710A.
  • The participant 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

  • The University of Arizona Sarver Heart Center (SHC)
  • Kansas University School of Medicine-Wichita
  • University of Cincinnati Medical Center
  • University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry
  • MHAT Targovishte AD
  • Diagnostic Consultative Center Mladost-M Varna OOD
  • Paediatric Sleep Research Inc.
  • E.S.E. Hospital Mental de Antioquia HOMO
  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.
  • Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS
  • Psynapsis Salud Mental S.A.
  • Marienthali Kliinik
  • Cabinet Psyche
  • Centre Medical Ambroise Pare
  • CHU de Nantes - Hopital Hotel Dieu
  • Univ. Freiburg
  • Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri
  • Klinik fur Kinderneurologie und Sozialpadiatrie Kinderzentrum Maulbronn gGmbH
  • University Hospital Tuebingen -
  • Vadaskert Child Psychiatric Hospital and Outpatient
  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  • Ramat Chen - Mental Health Clinic
  • Scientific Institute Fondazione Stella Maris
  • Sciaf Ulss 16 Padova
  • Hospital Trust-University of Cagliari
  • U.O.C. Neuropsichiatria Infantile - IRCCS Istituto Giannina Gaslini
  • Dip.Sc.Biomediche, Odont. e Imm.Funz.li, AOU Policlinico G. Martino
  • University Federico II Of Naples
  • Soon Chun Hyang University Hospital Cheonan
  • Asan Medical Center
  • Hospital Gintermuiza
  • Linda Keruze's Psychiatric Center, LLC
  • Children Hospilal -Gailezers
  • Sigulda Hospital Outpatient Clinic
  • Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)
  • Clinica Cemelli
  • Roberto Zepeda Sanchez
  • CRI Centro Regiomontano de Investigacion SC
  • Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C
  • B & B Investigaciones Medicas, SC
  • BIND Investigaciones S.C
  • Prywatne Gabinety Lekarskie Promedicus
  • Centrum Badan Klinicznych PI-House Sp. z o.o.
  • Przychodnia Syntonia Poradnia Zdrowia Psychicznego
  • Spectrum Centrum Psychiatrii Specjalistyczny Gabinet Psychiatryczny
  • Filip Rybakowski Specjalistyczna Praktyka Lekarska
  • Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu
  • Centrum Neuropsychiatrii Neuromed
  • Medicorehabilitation Research Center Phoenix
  • Stavropol Region Psychiatric Hospital No.2
  • Arkhangelsk Regional Clinical Mental Hospital
  • State Budgetary Healthcare Institution of Sverdlovsk Region ¿Sverdlovsk Regional Clinical Psychi...
  • GUZ Engels Psychiatric Hospital
  • State Budgetary Healthcare Institution (SBHI) Specialized Clinical Psychiatric Hospital 1 of the ...
  • Lipetsk Regional Psychoneurological Hospital
  • Nizhny Novgorod Region State Institution Of Healthcare Clinical Psychiatric Hospital 1 Of Nizhny ...
  • LLC City Neurological Center Sibneuromed
  • Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
  • Saratov State Medical University
  • Guz Saratov Regional Psychiatric Hospital St. Sofii
  • City Psychiatric Hospital No.3 named after I.I. Skvortsov-Stepanov
  • Nebbiolo LLC
  • Yaroslavl Regional Clinical Psychiatry Hospital
  • Child and Adolescent Neurology and Psychiatry Clinic
  • Institute of Mental Health
  • University Clinical Center Kragujevac
  • Clinical Center of Vojvodina - Clinic of Psychiatry
  • Daily Hospital for Children and Adolescents
  • Cape Trial Centre
  • Hospital Universitario Fundacion Alcorcon
  • Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo
  • Hospital General Universitario Gregorio Maranon
  • Ukrainian Research Institute Of Social, Forensic Psychiatry And Drug Abuse, Kiev City Psychoneuro...
  • Odessa Regional Medical Centre of Mental Health
  • Maltsev Poltava Regional Clinical Psychiatric Hospital, Higher State Educational Institution Of U...
  • Ternopil Regional Clinical Municipal Psycho-Neurological Hospital, Ternopil State Medical Univers...
  • NHS Greater Glasgow and Clyde Glasgow Clinical Research Facility-Queen Elizabeth University Hospi...
  • Alder Hey Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vortioxetine

Arm Description

Vortioxetine tablets for 26 weeks. Single dose of vortioxetine oral drops (only a subset of participants).

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAE was defined as an AE that started or increased in intensity on or after the date of first dose of study drug in this study 12712A. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.

Secondary Outcome Measures

Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 26
CDRS-R consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. Total score ranged from 17 (normal) to 113 (severe depression). Least square (LS) mean was calculated using a restricted maximum likelihood-based mixed model for repeated measurements (MMRM) approach.
Time to First Relapse
Relapse was defined as a total score ≥40 on the CDRS-R. CDRS-R consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. Total score ranged from 17 (normal) to 113 (severe depression).
Time to First Loss of Remission
Remission was defined as a total score ≤28 on the CDRS-R. CDRS-R consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. Total score ranged from 17 (normal) to 113 (severe depression).
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26
The CGI-S provides the clinician's impression of the participant's current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill participants). LS mean was calculated using a restricted maximum likelihood-based MMRM approach.
Clinical Global Impression - Global Improvement (CGI-I) Score
The CGI-I provides the clinician's impression of the participant's improvement (or worsening). The clinician assesses the participant's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). LS mean was calculated using a restricted maximum likelihood-based MMRM approach.
Children (7-11 Years): Change From Baseline in Behaviour Rating Inventory of Executive Function - Preschool (BRIEF-P) Using the Global Executive Composite (GEC) Score at Week 26
BRIEF form is an 86-item measure with symptoms rated on a 3-point likert scale of 1 "never", 2 "sometimes" or 3 "often". These items cover 8 non-overlapping clinical scales. For BRIEF-P form, only the first 72 items (Inhibit [10], Shift [8], Emotional Control [10], Initiate [8], Working Memory [10], Plan/Organize [12], Organization of Materials [6], Monitor [8]) were included in clinical scales. Clinical scales combined to form 2 indexes, Behavioural Regulation Index (BRI) and Metacognition Index (MI), and 1 composite summary score, the GEC, that incorporates all 8 clinical scales. GEC score was calculated as the sum of index scores ranging from 72-216; higher scores indicating greater impairment in executive functions. Raw scores converted to T-scores as detailed in T-score conversion tables for BRIEF-P. Conversion was based on gender and age group. T-scores ranged between 30 to 101, with a lower score indicating better functioning.
Adolescents (12-18 Years): Change From Baseline in Behaviour Rating Inventory of Executive Function - Self-report (BRIEF-SR) Using the GEC Score at Week 26
BRIEF form is an 86-item measure that assesses impairment in executive function with symptoms rated on a 3-point likert scale of 1 "never", 2 "sometimes" or 3 "often". These items cover 8 non-overlapping clinical scales. For BRIEF-SR form, only 80 items (Inhibit [13], Shift [10], Emotional Control [10], Initiate [5], Working Memory [12], Plan/Organize [13], Organization of Materials [7], Monitor [10]) were included in clinical scales. Clinical scales combined to form 2 indexes, the BRI and the MI, and 1 composite summary score, the GEC, that incorporates all 8 clinical scales. GEC score was calculated as the sum of index scores and ranges from 80-240 with higher scores indicating greater impairment in functions. Raw scores converted to T-scores as detailed in T-score conversion tables for BRIEF-SR. The conversion was based on gender and the age group. T-scores ranged between 29 to 104, with a lower score indicating better functioning.
Children (7-11 Years): Change From Baseline in BRIEF-P Using the MI Score at Week 26
BRIEF form is an 86-item measure that assesses impairment in executive function with symptoms rated on a 3-point likert scale of 1 "never", 2 "sometimes" or 3 "often". These items cover 8 non-overlapping clinical scales. Clinical scales combined to form 2 indexes, the BRI and the MI. For BRIEF-P, MI is comprised of Initiate (8), Working Memory (10), Plan/Organize (12), Organization of Materials (6), and Monitor (8) scales. The MI scores are calculated as the sum of the total 44 items ranging from 44 to 132 with lower scores reflecting better functioning. Raw scores converted to T-scores as detailed in T-score conversion tables for BRIEF-P. The conversion was based on gender and the age group. T-scores ranged between 30 to 98, with a lower score indicating better functioning.
Adolescents (12-18 Years): Change From Baseline in BRIEF-SR Using the MI Score at Week 26
BRIEF form is an 86-item measure that assesses impairment in executive function with symptoms rated on a 3-point likert scale of 1 "never", 2 "sometimes" or 3 "often". These items cover 8 non-overlapping clinical scales. Clinical scales combined to form 2 indexes, the BRI and the MI. For BRIEF-SR, MI is comprised of Working Memory (12), Plan/Organize (13), Organization of Materials (7), and Task Completion (10) scales. The MI scores are calculated as the sum of the total 42 items ranging from 42 to 126 with lower scores reflecting better functioning. Raw scores converted to T-scores as detailed in T-score conversion tables for BRIEF-SR. The conversion was based on gender and the age group. T-scores ranged between 31 to 100, with a lower score indicating better functioning.
Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Week 26
The CGAS is a clinician-rated global scale to measure the lowest level of functioning for a child (4 to 16 years) during a specified time period. The CGAS contains behaviourally-oriented descriptors at each anchor point that depict behaviours and life situations applicable to a child. The score ranges from 1 (most functionally impaired child) to 100 (the healthiest). A score greater than 70 indicates normal function.
Change From Baseline in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scale (PedsQL VAS) Total Score at Week 26
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL™ VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue, and pain using VAS. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. The total score is the average of all 6 items ranging from 0 to 10, where a lower value represents a better outcome.
Number of Participants With Response to the Palatability Questionnaire
The palatability of vortioxetine oral drops was assessed after intake of a single dose (5 to 20 mg) corresponding to the participant's current vortioxetine dose (replacing the vortioxetine tablet on that day). The palatability assessment included 4 questions on the overall appreciation of a medicinal product in relation to its taste (What do you think of the taste), mouthfeel (How does medicine feel in your mouth), aftertaste (What do you think of the after taste), and smell (What do you think of the smell). The items were rated on a 5-point hedonic scale; really bad, bad, neither good or bad, good, or very good. The oral drops were considered acceptable if the mean hedonic scores were ≤3 for each aspect of palatability (taste, aftertaste, smell, and mouthfeel).
Number of Participants With Response to the Acceptability Questionnaire
The acceptability of vortioxetine oral drops was assessed after intake of a single dose (5 to 20 mg) corresponding to the participant's current vortioxetine dose (replacing the vortioxetine tablet on that day). The acceptability assessment was based on 3 items; acceptability of the taste, whether the drops were perceived as easy to take, willingness to take the drops every day (provided it was the only available formulation). For each item the response options were no, not sure, and yes. The oral drops were considered acceptable if <60% of participants responded "no" to each of the 3 questions regarding acceptability.

Full Information

First Posted
August 15, 2016
Last Updated
November 22, 2022
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02871297
Brief Title
Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated based on new efficacy data from another study.
Study Start Date
August 17, 2016 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
April 19, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent participants 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
adolescent, children

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Vortioxetine
Arm Type
Experimental
Arm Description
Vortioxetine tablets for 26 weeks. Single dose of vortioxetine oral drops (only a subset of participants).
Intervention Type
Drug
Intervention Name(s)
Vortioxetine
Other Intervention Name(s)
Brintellix (R), Lu AA21004
Intervention Description
Target dose is 10 mg/day, however, the dose can be down- or uptitrated to 5, 15, or 20 mg/day.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAE was defined as an AE that started or increased in intensity on or after the date of first dose of study drug in this study 12712A. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Time Frame
Baseline up to Week 30
Secondary Outcome Measure Information:
Title
Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 26
Description
CDRS-R consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. Total score ranged from 17 (normal) to 113 (severe depression). Least square (LS) mean was calculated using a restricted maximum likelihood-based mixed model for repeated measurements (MMRM) approach.
Time Frame
Baseline, Week 26
Title
Time to First Relapse
Description
Relapse was defined as a total score ≥40 on the CDRS-R. CDRS-R consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. Total score ranged from 17 (normal) to 113 (severe depression).
Time Frame
Baseline up to Week 26
Title
Time to First Loss of Remission
Description
Remission was defined as a total score ≤28 on the CDRS-R. CDRS-R consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. Total score ranged from 17 (normal) to 113 (severe depression).
Time Frame
Baseline up to Week 26
Title
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26
Description
The CGI-S provides the clinician's impression of the participant's current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill participants). LS mean was calculated using a restricted maximum likelihood-based MMRM approach.
Time Frame
Baseline, Week 26
Title
Clinical Global Impression - Global Improvement (CGI-I) Score
Description
The CGI-I provides the clinician's impression of the participant's improvement (or worsening). The clinician assesses the participant's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). LS mean was calculated using a restricted maximum likelihood-based MMRM approach.
Time Frame
Week 26
Title
Children (7-11 Years): Change From Baseline in Behaviour Rating Inventory of Executive Function - Preschool (BRIEF-P) Using the Global Executive Composite (GEC) Score at Week 26
Description
BRIEF form is an 86-item measure with symptoms rated on a 3-point likert scale of 1 "never", 2 "sometimes" or 3 "often". These items cover 8 non-overlapping clinical scales. For BRIEF-P form, only the first 72 items (Inhibit [10], Shift [8], Emotional Control [10], Initiate [8], Working Memory [10], Plan/Organize [12], Organization of Materials [6], Monitor [8]) were included in clinical scales. Clinical scales combined to form 2 indexes, Behavioural Regulation Index (BRI) and Metacognition Index (MI), and 1 composite summary score, the GEC, that incorporates all 8 clinical scales. GEC score was calculated as the sum of index scores ranging from 72-216; higher scores indicating greater impairment in executive functions. Raw scores converted to T-scores as detailed in T-score conversion tables for BRIEF-P. Conversion was based on gender and age group. T-scores ranged between 30 to 101, with a lower score indicating better functioning.
Time Frame
Baseline, Week 26
Title
Adolescents (12-18 Years): Change From Baseline in Behaviour Rating Inventory of Executive Function - Self-report (BRIEF-SR) Using the GEC Score at Week 26
Description
BRIEF form is an 86-item measure that assesses impairment in executive function with symptoms rated on a 3-point likert scale of 1 "never", 2 "sometimes" or 3 "often". These items cover 8 non-overlapping clinical scales. For BRIEF-SR form, only 80 items (Inhibit [13], Shift [10], Emotional Control [10], Initiate [5], Working Memory [12], Plan/Organize [13], Organization of Materials [7], Monitor [10]) were included in clinical scales. Clinical scales combined to form 2 indexes, the BRI and the MI, and 1 composite summary score, the GEC, that incorporates all 8 clinical scales. GEC score was calculated as the sum of index scores and ranges from 80-240 with higher scores indicating greater impairment in functions. Raw scores converted to T-scores as detailed in T-score conversion tables for BRIEF-SR. The conversion was based on gender and the age group. T-scores ranged between 29 to 104, with a lower score indicating better functioning.
Time Frame
Baseline, Week 26
Title
Children (7-11 Years): Change From Baseline in BRIEF-P Using the MI Score at Week 26
Description
BRIEF form is an 86-item measure that assesses impairment in executive function with symptoms rated on a 3-point likert scale of 1 "never", 2 "sometimes" or 3 "often". These items cover 8 non-overlapping clinical scales. Clinical scales combined to form 2 indexes, the BRI and the MI. For BRIEF-P, MI is comprised of Initiate (8), Working Memory (10), Plan/Organize (12), Organization of Materials (6), and Monitor (8) scales. The MI scores are calculated as the sum of the total 44 items ranging from 44 to 132 with lower scores reflecting better functioning. Raw scores converted to T-scores as detailed in T-score conversion tables for BRIEF-P. The conversion was based on gender and the age group. T-scores ranged between 30 to 98, with a lower score indicating better functioning.
Time Frame
Baseline, Week 26
Title
Adolescents (12-18 Years): Change From Baseline in BRIEF-SR Using the MI Score at Week 26
Description
BRIEF form is an 86-item measure that assesses impairment in executive function with symptoms rated on a 3-point likert scale of 1 "never", 2 "sometimes" or 3 "often". These items cover 8 non-overlapping clinical scales. Clinical scales combined to form 2 indexes, the BRI and the MI. For BRIEF-SR, MI is comprised of Working Memory (12), Plan/Organize (13), Organization of Materials (7), and Task Completion (10) scales. The MI scores are calculated as the sum of the total 42 items ranging from 42 to 126 with lower scores reflecting better functioning. Raw scores converted to T-scores as detailed in T-score conversion tables for BRIEF-SR. The conversion was based on gender and the age group. T-scores ranged between 31 to 100, with a lower score indicating better functioning.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Week 26
Description
The CGAS is a clinician-rated global scale to measure the lowest level of functioning for a child (4 to 16 years) during a specified time period. The CGAS contains behaviourally-oriented descriptors at each anchor point that depict behaviours and life situations applicable to a child. The score ranges from 1 (most functionally impaired child) to 100 (the healthiest). A score greater than 70 indicates normal function.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scale (PedsQL VAS) Total Score at Week 26
Description
The PedsQL™ VAS is designed to measure at-that-moment functioning in children and adolescents. The PedsQL™ VAS consists of 6 domains: anxiety, sadness, anger, worry, fatigue, and pain using VAS. The functionality for each domain is measured on a 10 cm line with a happy face at one end and a sad face at the other (0-10 points). The participants are asked to mark on the line how they feel. The total score is the average of all 6 items ranging from 0 to 10, where a lower value represents a better outcome.
Time Frame
Baseline, Week 26
Title
Number of Participants With Response to the Palatability Questionnaire
Description
The palatability of vortioxetine oral drops was assessed after intake of a single dose (5 to 20 mg) corresponding to the participant's current vortioxetine dose (replacing the vortioxetine tablet on that day). The palatability assessment included 4 questions on the overall appreciation of a medicinal product in relation to its taste (What do you think of the taste), mouthfeel (How does medicine feel in your mouth), aftertaste (What do you think of the after taste), and smell (What do you think of the smell). The items were rated on a 5-point hedonic scale; really bad, bad, neither good or bad, good, or very good. The oral drops were considered acceptable if the mean hedonic scores were ≤3 for each aspect of palatability (taste, aftertaste, smell, and mouthfeel).
Time Frame
assessed at Baseline up to Week 26, Week 26 reported
Title
Number of Participants With Response to the Acceptability Questionnaire
Description
The acceptability of vortioxetine oral drops was assessed after intake of a single dose (5 to 20 mg) corresponding to the participant's current vortioxetine dose (replacing the vortioxetine tablet on that day). The acceptability assessment was based on 3 items; acceptability of the taste, whether the drops were perceived as easy to take, willingness to take the drops every day (provided it was the only available formulation). For each item the response options were no, not sure, and yes. The oral drops were considered acceptable if <60% of participants responded "no" to each of the 3 questions regarding acceptability.
Time Frame
assessed at Baseline up to Week 26, Week 26 reported

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participant is a male or female child aged ≥7 and <12 years or adolescent aged ≥12 and ≤18 years in the lead-in study (12709A and 12710A). The participant must have completed Study 12709A or 12710A (Visit 12, Completion Visit) immediately prior to enrolment into this extension study. The participant had a primary diagnosis of MDD at entry in study 12709A or 12710A, diagnosed according to DSM-5™. The participant is indicated for long-term treatment with vortioxetine according to the clinical opinion of the Investigator. For participants aged ≥7 and ≤17 years at the Baseline visit; the participant is able to understand the Informed Assent Form, and parent(s)/legal representative(s) are able to read and understand the Informed Consent Form. For participants who turned 18 years during the lead-in study 12710A; the participant has signed the Informed Consent Form. Exclusion Criteria: The participant has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A or 12710A. The participant 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
The University of Arizona Sarver Heart Center (SHC)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Kansas University School of Medicine-Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44012
Country
United States
Facility Name
MHAT Targovishte AD
City
Targovishte
ZIP/Postal Code
7700
Country
Bulgaria
Facility Name
Diagnostic Consultative Center Mladost-M Varna OOD
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Facility Name
Paediatric Sleep Research Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 3A3
Country
Canada
Facility Name
E.S.E. Hospital Mental de Antioquia HOMO
City
Bello
State/Province
Antioquia
ZIP/Postal Code
51050
Country
Colombia
Facility Name
Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
80020
Country
Colombia
Facility Name
Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS
City
Bogota
State/Province
DC
ZIP/Postal Code
111166
Country
Colombia
Facility Name
Psynapsis Salud Mental S.A.
City
Pereira
State/Province
Risaralda
Country
Colombia
Facility Name
Marienthali Kliinik
City
Tallinn
ZIP/Postal Code
11315
Country
Estonia
Facility Name
Cabinet Psyche
City
Douai
State/Province
Nord
ZIP/Postal Code
59500
Country
France
Facility Name
Centre Medical Ambroise Pare
City
Elancourt
ZIP/Postal Code
78990
Country
France
Facility Name
CHU de Nantes - Hopital Hotel Dieu
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Univ. Freiburg
City
Freiburg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
79104
Country
Germany
Facility Name
Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri
City
Mainz
ZIP/Postal Code
55122
Country
Germany
Facility Name
Klinik fur Kinderneurologie und Sozialpadiatrie Kinderzentrum Maulbronn gGmbH
City
Maulbronn
ZIP/Postal Code
75433
Country
Germany
Facility Name
University Hospital Tuebingen -
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Vadaskert Child Psychiatric Hospital and Outpatient
City
Budapest
ZIP/Postal Code
1021
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Ramat Chen - Mental Health Clinic
City
Tel Aviv
ZIP/Postal Code
6435807
Country
Israel
Facility Name
Scientific Institute Fondazione Stella Maris
City
Calambrone
State/Province
Pisa
ZIP/Postal Code
56026
Country
Italy
Facility Name
Sciaf Ulss 16 Padova
City
Padova
State/Province
Regione Veneto
ZIP/Postal Code
35143
Country
Italy
Facility Name
Hospital Trust-University of Cagliari
City
Cagliari
ZIP/Postal Code
09121
Country
Italy
Facility Name
U.O.C. Neuropsichiatria Infantile - IRCCS Istituto Giannina Gaslini
City
Genova
ZIP/Postal Code
16147
Country
Italy
Facility Name
Dip.Sc.Biomediche, Odont. e Imm.Funz.li, AOU Policlinico G. Martino
City
Messina
ZIP/Postal Code
98125
Country
Italy
Facility Name
University Federico II Of Naples
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Soon Chun Hyang University Hospital Cheonan
City
Cheonan-si
State/Province
Chungcheongnam-do
ZIP/Postal Code
31151
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Hospital Gintermuiza
City
Jelgava
ZIP/Postal Code
3008
Country
Latvia
Facility Name
Linda Keruze's Psychiatric Center, LLC
City
Liepaja
ZIP/Postal Code
LV-3401
Country
Latvia
Facility Name
Children Hospilal -Gailezers
City
Riga
ZIP/Postal Code
1079
Country
Latvia
Facility Name
Sigulda Hospital Outpatient Clinic
City
Sigulda
ZIP/Postal Code
LV-2150
Country
Latvia
Facility Name
Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)
City
Ciudad de Mexico
State/Province
Distrito Federal
ZIP/Postal Code
04530
Country
Mexico
Facility Name
Clinica Cemelli
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44200
Country
Mexico
Facility Name
Roberto Zepeda Sanchez
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44690
Country
Mexico
Facility Name
CRI Centro Regiomontano de Investigacion SC
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C
City
Culiacan De Rosales
State/Province
Sinaloa
ZIP/Postal Code
80230
Country
Mexico
Facility Name
B & B Investigaciones Medicas, SC
City
Mazatlan
State/Province
Sinaloa
ZIP/Postal Code
82140
Country
Mexico
Facility Name
BIND Investigaciones S.C
City
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Prywatne Gabinety Lekarskie Promedicus
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15879
Country
Poland
Facility Name
Centrum Badan Klinicznych PI-House Sp. z o.o.
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Przychodnia Syntonia Poradnia Zdrowia Psychicznego
City
Kielce
ZIP/Postal Code
25-103
Country
Poland
Facility Name
Spectrum Centrum Psychiatrii Specjalistyczny Gabinet Psychiatryczny
City
Lublin
ZIP/Postal Code
20-884
Country
Poland
Facility Name
Filip Rybakowski Specjalistyczna Praktyka Lekarska
City
Poznan
ZIP/Postal Code
60-744
Country
Poland
Facility Name
Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu
City
Walbrzych
ZIP/Postal Code
58300
Country
Poland
Facility Name
Centrum Neuropsychiatrii Neuromed
City
Wroclaw
ZIP/Postal Code
54-235
Country
Poland
Facility Name
Medicorehabilitation Research Center Phoenix
City
Rostov-On-Don
State/Province
Rostov State
ZIP/Postal Code
344010
Country
Russian Federation
Facility Name
Stavropol Region Psychiatric Hospital No.2
City
Stavropol
State/Province
Stavropol Region
ZIP/Postal Code
357034
Country
Russian Federation
Facility Name
Arkhangelsk Regional Clinical Mental Hospital
City
Arkhangelsk
ZIP/Postal Code
163530
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Sverdlovsk Region ¿Sverdlovsk Regional Clinical Psychi...
City
Ekaterinburg
ZIP/Postal Code
620030
Country
Russian Federation
Facility Name
GUZ Engels Psychiatric Hospital
City
Engels
ZIP/Postal Code
413124
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution (SBHI) Specialized Clinical Psychiatric Hospital 1 of the ...
City
Krasnodar
ZIP/Postal Code
350007
Country
Russian Federation
Facility Name
Lipetsk Regional Psychoneurological Hospital
City
Lipetsk
ZIP/Postal Code
398007
Country
Russian Federation
Facility Name
Nizhny Novgorod Region State Institution Of Healthcare Clinical Psychiatric Hospital 1 Of Nizhny ...
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
LLC City Neurological Center Sibneuromed
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Saratov State Medical University
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Guz Saratov Regional Psychiatric Hospital St. Sofii
City
Saratov
ZIP/Postal Code
410060
Country
Russian Federation
Facility Name
City Psychiatric Hospital No.3 named after I.I. Skvortsov-Stepanov
City
St-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Nebbiolo LLC
City
Tomsk
ZIP/Postal Code
634009
Country
Russian Federation
Facility Name
Yaroslavl Regional Clinical Psychiatry Hospital
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Child and Adolescent Neurology and Psychiatry Clinic
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute of Mental Health
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center of Vojvodina - Clinic of Psychiatry
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Daily Hospital for Children and Adolescents
City
Pantelej-Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Cape Trial Centre
City
Bellville
State/Province
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Hospital Universitario Fundacion Alcorcon
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo
City
Torremolinos
State/Province
Malaga
ZIP/Postal Code
29620
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Ukrainian Research Institute Of Social, Forensic Psychiatry And Drug Abuse, Kiev City Psychoneuro...
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Odessa Regional Medical Centre of Mental Health
City
Odessa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
Maltsev Poltava Regional Clinical Psychiatric Hospital, Higher State Educational Institution Of U...
City
Poltava
ZIP/Postal Code
36013
Country
Ukraine
Facility Name
Ternopil Regional Clinical Municipal Psycho-Neurological Hospital, Ternopil State Medical Univers...
City
Ternopil
ZIP/Postal Code
46000
Country
Ukraine
Facility Name
NHS Greater Glasgow and Clyde Glasgow Clinical Research Facility-Queen Elizabeth University Hospi...
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Alder Hey Hospital
City
Liverpool
ZIP/Postal Code
L12 2AP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age

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