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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

Sponsor
H. Lundbeck A/S (Industry)
Overall Status
Terminated
CT.gov ID
NCT02871297
Collaborator
(none)
663
Enrollment
78
Locations
2
Arms
68
Actual Duration (Months)
8.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
663 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 17, 2016
Actual Primary Completion Date :
Mar 25, 2022
Actual Study Completion Date :
Apr 19, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vortioxetine tablets

Vortioxetine tablets for 26 weeks

Drug: Vortioxetine
Target dose is 10 mg/day, however, the dose can be down- or uptitrated to 5, 15, or 20 mg/day.
Other Names:
  • Brintellix (R)
  • Lu AA21004

    		•
    Experimental: Vortioxetine

    Single dose of vortioxetine oral drops (only a subset of patients)

    Drug: Vortioxetine
    5, 10, 15 or 20 mg
    Other Names:
  • Brintellix (R)
  • Lu AA21004

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with Treatment-Emergent Adverse Events [Baseline to Week 26]

      Safety based on paediatric adverse event rating scale (PAERS), safety assessments (clinical safety laboratory tests, vital signs, weight, height, Tanner score, menstrual cycle, ECG parameters)

    Secondary Outcome Measures

    1. Change in CDRS-R total score [from baseline to Week 26]

      Children Depression Rating Scale - Revised version

    2. Time to first relapse (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration) [Up to Week 26]

      Children Depression Rating Scale - Revised version

    3. Time to first loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration) [Up to Week 26]

      Children Depression Rating Scale - Revised version

    4. Change in Clinical Global Impression - Severity of Illness (CGI-S) score [from baseline to Week 26]

      Clinical Global Impression - Severity of Illness

    5. Clinical Global Impression - Global Improvement (CGI-I) score [Week 26]

      Clinical Global Impression - Global Improvement

    6. Children (7-11 years): Change in Behaviour Rating Inventory of Executive Function (BRIEF) using the Global Executive Composite score [from baseline to Week 26]

      Behaviour Rating Inventory of Executive Function

    7. Children (7-11 years): Change in BRIEF using the Metacognition Index [from baseline to Week 26]

      Behaviour Rating Inventory of Executive Function

    8. Adolescents (12-18 years): Change in BRIEF-Self-report (SR) using the Global Executive Composite score [from baseline to Week 26]

      Behaviour Rating Inventory of Executive Function - Self-report version

    9. Adolescents (12-18 years): Change in BRIEF-SR using the Metacognition Index [from baseline to Week 26]

      Behaviour Rating Inventory of Executive Function - Self-report version

    10. Change in Children's Global Assessment Scale (CGAS) score [from baseline to Week 26]

      Children's Global Assessment Scale

    11. Change in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) score [from baseline to Week 26]

      Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales

    12. Absolute value of palatability scores [At Visit 5, 7, 9 or 11]

      Palatability is evaluated using 5-point facial hedonic scales (FHS) for 4 different attributes: taste, mouthfeel, aftertaste and smell. Palatability item scores will be summarized using descriptive statistics. That is, the item scores will be summarized for each of the four palatability assessments.

    13. Absolute value of acceptability item scores in number of percentage [At Visit 5, 7, 9 or 11]

      Acceptability assessment is based on 3 items: acceptability of the taste, whether the formulation was perceived as easy to take and willingness to take the formulation every day. Acceptability item scores will be summarized using descriptive statistics'. Number with percentage will be presented for each item of 'acceptability'.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • The patient 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 patient must have completed Study 12709A or 12710A (Visit 12, Completion Visit) immediately prior to enrolment into this extension study.

    • The patient had a primary diagnosis of MDD at entry in study 12709A or 12710A, diagnosed according to DSM-5™.

    • The patient is indicated for long-term treatment with vortioxetine according to the clinical opinion of the Investigator.

    • For patients aged ≥7 and ≤17 years at the Baseline visit; the patient 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 patients who turned 18 years during the lead-in study 12710A; the patient has signed the Informed Consent Form.

    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.

    Other protocol-defined inclusion and exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Arizona Sarver Heart Center (SHC) Tucson Arizona United States 85724
    2 Kansas University School of Medicine-Wichita Wichita Kansas United States 67214
    3 University of Cincinnati Medical Center Cincinnati Ohio United States 45219
    4 University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry Cleveland Ohio United States 44012
    5 MHAT Targovishte AD Targovishte Bulgaria 7700
    6 Diagnostic Consultative Center Mladost-M Varna OOD Varna Bulgaria 9020
    7 Paediatric Sleep Research Inc. Toronto Ontario Canada M5S 3A3
    8 E.S.E. Hospital Mental de Antioquia HOMO Bello Antioquia Colombia 51050
    9 Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS. Barranquilla Atlantico Colombia 80020
    10 Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS Bogota DC Colombia 111166
    11 Psynapsis Salud Mental S.A. Pereira Risaralda Colombia
    12 Marienthali Kliinik Tallinn Estonia 11315
    13 Cabinet Psyche Douai Nord France 59500
    14 Centre Medical Ambroise Pare Elancourt France 78990
    15 CHU de Nantes - Hopital Hotel Dieu Nantes Cedex 1 France 44093
    16 Univ. Freiburg Freiburg Baden-Wurttemberg Germany 79104
    17 Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri Mainz Germany 55122
    18 Klinik fur Kinderneurologie und Sozialpadiatrie Kinderzentrum Maulbronn gGmbH Maulbronn Germany 75433
    19 University Hospital Tuebingen - Tuebingen Germany 72076
    20 Vadaskert Child Psychiatric Hospital and Outpatient Budapest Hungary 1021
    21 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza Gyula Hungary 5700
    22 Ramat Chen - Mental Health Clinic Tel Aviv Israel 6435807
    23 Scientific Institute Fondazione Stella Maris Calambrone Pisa Italy 56026
    24 Sciaf Ulss 16 Padova Padova Regione Veneto Italy 35143
    25 Hospital Trust-University of Cagliari Cagliari Italy 09121
    26 U.O.C. Neuropsichiatria Infantile - IRCCS Istituto Giannina Gaslini Genova Italy 16147
    27 Dip.Sc.Biomediche, Odont. e Imm.Funz.li, AOU Policlinico G. Martino Messina Italy 98125
    28 University Federico II Of Naples Napoli Italy 80131
    29 Soon Chun Hyang University Hospital Cheonan Cheonan-si Chungcheongnam-do Korea, Republic of 31151
    30 Asan Medical Center Seoul Korea, Republic of 05505
    31 Hospital Gintermuiza Jelgava Latvia 3008
    32 Linda Keruze's Psychiatric Center, LLC Liepaja Latvia LV-3401
    33 Children Hospilal -Gailezers Riga Latvia 1079
    34 Sigulda Hospital Outpatient Clinic Sigulda Latvia LV-2150
    35 Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics) Ciudad de Mexico Distrito Federal Mexico 04530
    36 Clinica Cemelli Guadalajara Jalisco Mexico 44200
    37 Roberto Zepeda Sanchez Guadalajara Jalisco Mexico 44690
    38 CRI Centro Regiomontano de Investigacion SC Monterrey Nuevo Leon Mexico 64000
    39 Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C Culiacan De Rosales Sinaloa Mexico 80230
    40 B & B Investigaciones Medicas, SC Mazatlan Sinaloa Mexico 82140
    41 BIND Investigaciones S.C San Luis Potosi Mexico 78213
    42 Prywatne Gabinety Lekarskie Promedicus Bialystok Podlaskie Poland 15879
    43 Centrum Badan Klinicznych PI-House Sp. z o.o. Gdansk Poland 80-546
    44 Przychodnia Syntonia Poradnia Zdrowia Psychicznego Kielce Poland 25-103
    45 Spectrum Centrum Psychiatrii Specjalistyczny Gabinet Psychiatryczny Lublin Poland 20-884
    46 Filip Rybakowski Specjalistyczna Praktyka Lekarska Poznan Poland 60-744
    47 Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu Walbrzych Poland 58300
    48 Centrum Neuropsychiatrii Neuromed Wroclaw Poland 54-235
    49 Medicorehabilitation Research Center Phoenix Rostov-On-Don Rostov State Russian Federation 344010
    50 Stavropol Region Psychiatric Hospital No.2 Stavropol Stavropol Region Russian Federation 357034
    51 Arkhangelsk Regional Clinical Mental Hospital Arkhangelsk Russian Federation 163530
    52 State Budgetary Healthcare Institution of Sverdlovsk Region ¿Sverdlovsk Regional Clinical Psychi... Ekaterinburg Russian Federation 620030
    53 GUZ Engels Psychiatric Hospital Engels Russian Federation 413124
    54 State Budgetary Healthcare Institution (SBHI) Specialized Clinical Psychiatric Hospital 1 of the ... Krasnodar Russian Federation 350007
    55 Lipetsk Regional Psychoneurological Hospital Lipetsk Russian Federation 398007
    56 Nizhny Novgorod Region State Institution Of Healthcare Clinical Psychiatric Hospital 1 Of Nizhny ... Nizhny Novgorod Russian Federation 603155
    57 LLC City Neurological Center Sibneuromed Novosibirsk Russian Federation 630091
    58 Rostov State Medical University of the Minzdravsotsrazvitiya of Russia Rostov-on-Don Russian Federation 344022
    59 Saratov State Medical University Saratov Russian Federation 410028
    60 Guz Saratov Regional Psychiatric Hospital St. Sofii Saratov Russian Federation 410060
    61 City Psychiatric Hospital No.3 named after I.I. Skvortsov-Stepanov St-Petersburg Russian Federation 197341
    62 Nebbiolo LLC Tomsk Russian Federation 634009
    63 Yaroslavl Regional Clinical Psychiatry Hospital Yaroslavl Russian Federation 150003
    64 Child and Adolescent Neurology and Psychiatry Clinic Belgrade Serbia 11000
    65 Institute of Mental Health Belgrade Serbia 11000
    66 University Clinical Center Kragujevac Kragujevac Serbia 34000
    67 Clinical Center of Vojvodina - Clinic of Psychiatry Novi Sad Serbia 21000
    68 Daily Hospital for Children and Adolescents Pantelej-Nis Serbia 18000
    69 Cape Trial Centre Bellville Cape Town South Africa 7530
    70 Hospital Universitario Fundacion Alcorcon Alcorcon Madrid Spain 28922
    71 Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo Torremolinos Malaga Spain 29620
    72 Hospital General Universitario Gregorio Maranon Madrid Spain 28009
    73 Ukrainian Research Institute Of Social, Forensic Psychiatry And Drug Abuse, Kiev City Psychoneuro... Kyiv Ukraine 04080
    74 Odessa Regional Medical Centre of Mental Health Odessa Ukraine 65006
    75 Maltsev Poltava Regional Clinical Psychiatric Hospital, Higher State Educational Institution Of U... Poltava Ukraine 36013
    76 Ternopil Regional Clinical Municipal Psycho-Neurological Hospital, Ternopil State Medical Univers... Ternopil Ukraine 46000
    77 NHS Greater Glasgow and Clyde Glasgow Clinical Research Facility-Queen Elizabeth University Hospi... Glasgow United Kingdom G51 4TF
    78 Alder Hey Hospital Liverpool United Kingdom L12 2AP

    Sponsors and Collaborators

    • H. Lundbeck A/S

    Investigators

    • Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    H. Lundbeck A/S
    ClinicalTrials.gov Identifier:
    NCT02871297
    Other Study ID Numbers:
    • 12712A
    • 2008-005356-25
    First Posted:
    Aug 18, 2016
    Last Update Posted:
    May 24, 2022
    Last Verified:
    May 1, 2022
    Keywords provided by H. Lundbeck A/S
    adolescent
    children
    Additional relevant MeSH terms:
    Depressive Disorder
    Depression
    Depressive Disorder, Major
    Vortioxetine

    Study Results

    No Results Posted as of May 24, 2022