Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)
NCT ID: NCT02709655
Last Updated: 2022-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
683 participants
INTERVENTIONAL
2016-05-18
2022-01-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vortioxetine 10 mg/day
Vortioxetine 10 mg/day
10 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed
Vortioxetine 20 mg/day
Vortioxetine 20 mg/day
20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed
Fluoxetine 20 mg/day,
A decision has been taken to stop recruitment into this treatment arm.
Fluoxetine 20mg/day
20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed
Placebo
Placebo
Encapsulated tablet, orally
Interventions
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Vortioxetine 10 mg/day
10 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed
Vortioxetine 20 mg/day
20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed
Fluoxetine 20mg/day
20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed
Placebo
Encapsulated tablet, orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The participant has a CDRS-R total score ≥45 at the Screening Visit and the Baseline.
3. The participant has a CGI-S score ≥4 at the Screening Visit and the Baseline.
4. The participant is a boy or girl, aged ≥7 and \<12 years at Screening Visit
5. The participant has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.
Exclusion Criteria
2. The participant has previously participated in a study with vortioxetine.
7 Years
11 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Woodland International Research Group
Little Rock, Arkansas, United States
Sun Valley Research Center
Imperial, California, United States
Synergy Clinical Research Center
Lemon Grove, California, United States
Alliance for Wellness dba Alliance for Research
Long Beach, California, United States
NRC Research Institute
Orange, California, United States
Asclepes Research Center
Panorama City, California, United States
Children's National Medical Center Merge
Washington D.C., District of Columbia, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Northwest Behavioral Research Center
Marietta, Georgia, United States
American Medical Research, Inc.
Chicago, Illinois, United States
AMR- Baber Research, Inc.
Naperville, Illinois, United States
AMR Conventions Research
Warrenville, Illinois, United States
Kansas University School of Medicine-Wichita
Wichita, Kansas, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
Kennedy Krieger Institute
Baltimore, Maryland, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, United States
Millennium Psychiatric Associates, LLC
St Louis, Missouri, United States
Princeton Medical Institute
Princeton, New Jersey, United States
Manhattan Behavioral Medicine
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry
Cleveland, Ohio, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Paradigm Research Professionals, LLC
Oklahoma City, Oklahoma, United States
Research Strategies Of Memphis, Llc
Memphis, Tennessee, United States
BioBehavioral Research of Austin
Austin, Texas, United States
AIM Trials, LLC
Plano, Texas, United States
Research Across America
Plano, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Westside Medical
Clinton, Utah, United States
Aspen Clinical Research, LLC
Orem, Utah, United States
MHAT Targovishte AD
Targovisthe, , Bulgaria
Diagnostic Consultative Center Mladost-M Varna OOD
Varna, , Bulgaria
Paediatric Sleep Research Inc.
Toronto, Ontario, Canada
E.S.E. Hospital Mental de Antioquia HOMO
Bello, Antioquia, Colombia
Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.
Barranquilla, Atlántico, Colombia
Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS
Bogotá, DC, Colombia
Psynapsis Salud Mental S.A.
Pereira, Risaralda Department, Colombia
Marienthali Kliinik
Tallinn, , Estonia
Cabinet Psyche
Douai, Nord, France
Centre Medical Ambroise Pare
Élancourt, , France
CHU de Nantes - Hopital Hotel Dieu
Nantes, , France
Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri
Mainz, , Germany
Vadaskert Alapitvany
Budapest, , Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Gyula, , Hungary
Shalvata Mental Health Center
Hod HaSharon, , Israel
Ramat Chen - Mental Health Clinic
Tel Aviv, , Israel
The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
Tel Litwinsky, , Israel
Scientific Institute Fondazione Stella Maris
Calambrone Pisa, Pisa, Italy
Sciaf Ulss 16 Padova
Padua, Regione Veneto, Italy
University Federico II Of Naples
Napoli, , Italy
Linda Keruze's Psychiatric Center, LLC
Liepāja, , Latvia
Children Hospilal -Gailezers
Riga, , Latvia
Centro Investigacion Medico Biologica Y Terapia Avanzada
Guadalajara, Jalisco, Mexico
Clinica Cemelli
Guadalajara, Jalisco, Mexico
Roberto Zepeda Sanchez
Guadalajara, Jalisco, Mexico
Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)
Mexico City, Mexico City, Mexico
CRI Centro Regiomontano de Investigacion SC
Monterrey, Nuevo León, Mexico
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C
Culiacan de Rosales, Sinaloa, Mexico
B & B Investigaciones Medicas, SC
Mazatlán, Sinaloa, Mexico
ICARO Investigaciones en Medicina S.A. de C.V.
Chihuahua City, , Mexico
BIND Investigaciones S.C
San Luis Potosí City, , Mexico
Prywatne Gabinety Lekarskie Promedicus
Bialystok, Podlaskie Voivodeship, Poland
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, , Poland
Przychodnia Syntonia Poradnia Zdrowia Psychicznego
Kielce, , Poland
Spectrum Centrum Psychiatrii Specjalistyczny Gabinet Psychiatryczny
Lublin, , Poland
Filip Rybakowski Specjalistyczna Praktyka Lekarska
Poznan, , Poland
Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu
Wałbrzych, , Poland
Medicorehabilitation Research Center Phoenix
Rostov-on-Don, Rostov State, Russia
Stavropol Region Psychiatric Hospital No.2
Stavropol, Stavropol Kray, Russia
Arkhangelsk Regional Clinical Mental Hospital
Arkhangelsk, , Russia
GUZ Engels Psychiatric Hospital
Engel's, , Russia
State Budgetary Healthcare Institution (SBHI) Specialized Clinical Psychiatric Hospital 1 of the ...
Krasnodar, , Russia
LLC City Neurological Center Sibneuromed
Novosibirsk, , Russia
Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
Rostov-on-Don, , Russia
City Psychiatric Hospital No.3 named after I.I. Skvortsov-Stepanov
Saint Petersburg, , Russia
Saratov State Medical University
Saratov, , Russia
Guz Saratov Regional Psychiatric Hospital St. Sofii
Saratov, , Russia
Nebbiolo LLC
Tomsk, , Russia
Yaroslavl Regional Clinical Psychiatry Hospital
Yaroslavl, , Russia
State Budgetary Healthcare Institution of Sverdlovsk Region ¿Sverdlovsk Regional Clinical Psychi...
Yekaterinburg, , Russia
Child and Adolescent Neurology and Psychiatry Clinic
Belgrade, , Serbia
Institute of Mental Health
Belgrade, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
Clinical Center of Vojvodina - Clinic of Psychiatry
Novi Sad, , Serbia
Daily Hospital for Children and Adolescents
Pantelej-Nis, , Serbia
Cape Trial Centre
Bellville, Cape Town, South Africa
Tara Hospital
Sandhurst, Gauteng, South Africa
Seoul National University Hospital
Seoul, , South Korea
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, Spain
Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo
Torremolinos, Malaga, Spain
Ukrainian Research Institute Of Social, Forensic Psychiatry And Drug Abuse, Kiev City Psychoneuro...
Kyiv, , Ukraine
Odessa Regional Medical Centre of Mental Health
Odesa, , Ukraine
Maltsev Poltava Regional Clinical Psychiatric Hospital, Higher State Educational Institution Of U...
Poltava, , Ukraine
Ternopil Regional Clinical Municipal Psycho-Neurological Hospital, Ternopil State Medical Univers...
Ternopil, , Ukraine
Countries
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References
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Huss M, Findling RL, DelBello MP, Necking O, Petersen ML, Schmidt SN, Rosen M. Vortioxetine for Major Depressive Disorder in Children: 12-Week Randomized, Placebo-Controlled Study. JAACAP Open. 2024 Nov 22;3(3):736-748. doi: 10.1016/j.jaacop.2024.11.002. eCollection 2025 Sep.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2008-005353-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12709A
Identifier Type: -
Identifier Source: org_study_id
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