Clinical trial NCT02709655: Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)
Official title: Interventional, Randomized, 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Keywords: paediatric
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: Takeda
First posted: 2016-03-16
Enrollment: 683
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric participants (age 7 to 11 years).


Eligibility criteria: Inclusion Criteria:

1. The participant has MDD, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5™).
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:

1. The participant has participated in a clinical study \<30 days prior to the Screening Visit.
2. The participant has previously participated in a study with vortioxetine.

Other protocol defined inclusion and exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 8 of Phase B
timeFrame: Baseline (Week 4 of Phase A), Week 8 of Phase B
Secondary outcomes:
measure: Change From Baseline in CDRS-R Total Score at Weeks 2, 4, and 6 of Phase B
timeFrame: Baseline (Week 4 of Phase A), Weeks 2, 4, and 6 of Phase B
measure: Change From Baseline in CDRS-R Subscores (Mood, Somatic, Subjective, and Behaviour) at Weeks 2, 4, 6, and 8 of Phase B
timeFrame: Baseline (Week 4 of Phase A), Weeks 2, 4, 6, and 8 of Phase B
measure: Percentage of Participants With CDRS-R Response
timeFrame: Weeks 2, 4, 6, and 8 of Phase B
measure: Percentage of Participants With CDRS-R Remission
timeFrame: Weeks 2, 4, 6, and 8 of Phase B
measure: Change From Baseline in General Behaviour Inventory (GBI) Depression Subscale Score, Using the 10-Item Depression Subscale Assessed by Parent (PGBI-10D) and Child (CGBI-10D) at Weeks 2, 4, 6, and 8 of Phase B
timeFrame: Baseline (Week 4 of Phase A), Weeks 2, 4, 6, and 8 of Phase B
measure: Parent Global Assessment (PGA) Score
timeFrame: Weeks 2, 4, 6, and 8 of Phase B
measure: Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 3, 4, 6, and 8 of Phase B
timeFrame: Baseline (Week 4 of Phase A), Weeks 1, 2, 3, 4, 6, and 8 of Phase B
measure: Clinical Global Impression - Global Improvement (CGI-I) Score
timeFrame: Weeks 1, 2, 3, 4, 6, and 8 of Phase B
measure: Percentage of Participants With CGI-S Remission
timeFrame: Weeks 1, 2, 3, 4, 6, and 8 of Phase B
measure: Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Weeks 4 and 8 of Phase B
timeFrame: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
measure: Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Visual Analogue Scales (VAS): Afraid or Scared (Anxiety) Score at Weeks 4 and 8 of Phase B
timeFrame: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
measure: Change From Baseline in PedsQL VAS: Sad or Blue (Sadness) Score at Weeks 4 and 8 of Phase B
timeFrame: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
measure: Change From Baseline in PedsQL VAS: Angry Score at Weeks 4 and 8 of Phase B
timeFrame: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
measure: Change From Baseline in PedsQL VAS: Worry Score at Weeks 4 and 8 of Phase B
timeFrame: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
measure: Change From Baseline in PedsQL VAS: Tired (Fatigue) Score at Weeks 4 and 8 of Phase B
timeFrame: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
measure: Change From Baseline in PedsQL VAS: Pain or Hurt Score at Weeks 4 and 8 of Phase B
timeFrame: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
measure: Change From Baseline in PedsQL VAS Total Average Score at Weeks 4 and 8 of Phase B
timeFrame: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
measure: Change From Baseline in PedsQL Emotional Distress Summary Average Score at Weeks 4 and 8 of Phase B
timeFrame: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
measure: Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Weeks 4 and 8 of Phase B
timeFrame: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
measure: Change From Baseline in PQ-LES-Q Overall Evaluation Score (Item 15) at Weeks 4 and 8 of Phase B
timeFrame: Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Lemon Grove
country: United States
facility: Synergy Clinical Research Center
state: California
city: Long Beach
country: United States
facility: Alliance for Wellness dba Alliance for Research
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Panorama City
country: United States
facility: Asclepes Research Center
state: California
city: Washington
country: United States
facility: Children's National Medical Center Merge
state: District of Columbia
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Marietta
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Chicago
country: United States
facility: American Medical Research, Inc.
state: Illinois
city: Naperville
country: United States
facility: AMR- Baber Research, Inc.
state: Illinois
city: Warrenville
country: United States
facility: AMR Conventions Research
state: Illinois
city: Wichita
country: United States
facility: Kansas University School of Medicine-Wichita
state: Kansas
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates - Midwest Research Group
state: Missouri
city: Saint Louis
country: United States
facility: Millennium Psychiatric Associates, LLC
state: Missouri
city: Princeton
country: United States
facility: Princeton Medical Institute
state: New Jersey
city: New York
country: United States
facility: Manhattan Behavioral Medicine
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Paradigm Research Professionals, LLC
state: Oklahoma
city: Memphis
country: United States
facility: Research Strategies Of Memphis, Llc
state: Tennessee
city: Austin
country: United States
facility: BioBehavioral Research of Austin
state: Texas
city: Plano
country: United States
facility: AIM Trials, LLC
state: Texas
city: Plano
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Clinton
country: United States
facility: Westside Medical
state: Utah
city: Orem
country: United States
facility: Aspen Clinical Research, LLC
state: Utah
city: Targovisthe
country: Bulgaria
facility: MHAT Targovishte AD
city: Varna
country: Bulgaria
facility: Diagnostic Consultative Center Mladost-M Varna OOD
city: Toronto
country: Canada
facility: Paediatric Sleep Research Inc.
state: Ontario
city: Bello
country: Colombia
facility: E.S.E. Hospital Mental de Antioquia HOMO
state: Antioquia
city: Barranquilla
country: Colombia
facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.
state: Atlantico
city: Bogota
country: Colombia
facility: Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS
state: DC
city: Pereira
country: Colombia
facility: Psynapsis Salud Mental S.A.
state: Risaralda
city: Tallinn
country: Estonia
facility: Marienthali Kliinik
city: Douai
country: France
facility: Cabinet Psyche
state: Nord
city: Elancourt
country: France
facility: Centre Medical Ambroise Pare
city: Nantes Cedex 1
country: France
facility: CHU de Nantes - Hopital Hotel Dieu
city: Mainz
country: Germany
facility: Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri
city: Budapest
country: Hungary
facility: Vadaskert Alapitvany
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
city: Hod Hasharon
country: Israel
facility: Shalvata Mental Health Center
city: Tel Aviv
country: Israel
facility: Ramat Chen - Mental Health Clinic
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
city: Calambrone Pisa
country: Italy
facility: Scientific Institute Fondazione Stella Maris
state: Pisa
city: Padova
country: Italy
facility: Sciaf Ulss 16 Padova
state: Regione Veneto
city: Napoli
country: Italy
facility: University Federico II Of Naples
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Liepaja
country: Latvia
facility: Linda Keruze's Psychiatric Center, LLC
city: Riga
country: Latvia
facility: Children Hospilal -Gailezers
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro Investigacion Medico Biologica Y Terapia Avanzada
state: Jalisco
city: Guadalajara
country: Mexico
facility: Clinica Cemelli
state: Jalisco
city: Guadalajara
country: Mexico
facility: Roberto Zepeda Sanchez
state: Jalisco
city: Monterrey
country: Mexico
facility: CRI Centro Regiomontano de Investigacion SC
state: Nuevo Leon
city: Culiacan De Rosales
country: Mexico
facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C
state: Sinaloa
city: Mazatlan
country: Mexico
facility: B & B Investigaciones Medicas, SC
state: Sinaloa
city: Chihuahua
country: Mexico
facility: ICARO Investigaciones en Medicina S.A. de C.V.
city: San Luis Potosi
country: Mexico
facility: BIND Investigaciones S.C
city: Bialystok
country: Poland
facility: Prywatne Gabinety Lekarskie Promedicus
state: Podlaskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House Sp. z o.o.
city: Kielce
country: Poland
facility: Przychodnia Syntonia Poradnia Zdrowia Psychicznego
city: Lublin
country: Poland
facility: Spectrum Centrum Psychiatrii Specjalistyczny Gabinet Psychiatryczny
city: Poznan
country: Poland
facility: Filip Rybakowski Specjalistyczna Praktyka Lekarska
city: Walbrzych
country: Poland
facility: Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu
city: Rostov-On-Don
country: Russian Federation
facility: Medicorehabilitation Research Center Phoenix
state: Rostov State
city: Stavropol
country: Russian Federation
facility: Stavropol Region Psychiatric Hospital No.2
state: Stavropol Region
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Mental Hospital
city: Ekaterinburg
country: Russian Federation
facility: State Budgetary Healthcare Institution of Sverdlovsk Region Â¿Sverdlovsk Regional Clinical Psychi...
city: Engels
country: Russian Federation
facility: GUZ Engels Psychiatric Hospital
city: Krasnodar
country: Russian Federation
facility: State Budgetary Healthcare Institution (SBHI) Specialized Clinical Psychiatric Hospital 1 of the ...
city: Novosibirsk
country: Russian Federation
facility: LLC City Neurological Center Sibneuromed
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
city: Saratov
country: Russian Federation
facility: Saratov State Medical University
city: Saratov
country: Russian Federation
facility: Guz Saratov Regional Psychiatric Hospital St. Sofii
city: St-Petersburg
country: Russian Federation
facility: City Psychiatric Hospital No.3 named after I.I. Skvortsov-Stepanov
city: Tomsk
country: Russian Federation
facility: Nebbiolo LLC
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinical Psychiatry Hospital
city: Belgrade
country: Serbia
facility: Child and Adolescent Neurology and Psychiatry Clinic
city: Belgrade
country: Serbia
facility: Institute of Mental Health
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina - Clinic of Psychiatry
city: Pantelej-Nis
country: Serbia
facility: Daily Hospital for Children and Adolescents
city: Bellville
country: South Africa
facility: Cape Trial Centre
state: Cape Town
city: Sandhurst
country: South Africa
facility: Tara Hospital
state: Gauteng
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
state: Madrid
city: Torremolinos
country: Spain
facility: Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo
state: Malaga
city: Kyiv
country: Ukraine
facility: Ukrainian Research Institute Of Social, Forensic Psychiatry And Drug Abuse, Kiev City Psychoneuro...
city: Odessa
country: Ukraine
facility: Odessa Regional Medical Centre of Mental Health
city: Poltava
country: Ukraine
facility: Maltsev Poltava Regional Clinical Psychiatric Hospital, Higher State Educational Institution Of U...
city: Ternopil
country: Ukraine
facility: Ternopil Regional Clinical Municipal Psycho-Neurological Hospital, Ternopil State Medical Univers...
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via Lundbeck A/S
role: STUDY_DIRECTOR
References: