Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)

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)

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

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Vortioxetine 10 mg/day; Drug: Vortioxetine 20 mg/day; Drug: Fluoxetine 20mg/day; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 683
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Targovisthe, Bulgaria, 7700
    • MHAT Targovishte AD
  • Varna, Bulgaria, 9020
    • Diagnostic Consultative Center Mladost-M Varna OOD
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 3A3
      • Paediatric Sleep Research Inc.
• Colombia
  • Antioquia
    • Bello, Antioquia, Colombia, 51050
      • E.S.E. Hospital Mental de Antioquia HOMO
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 80020
      • Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.
  • DC
    • Bogota, DC, Colombia, 111166
      • Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS
  • Risaralda
    • Pereira, Risaralda, Colombia
      • Psynapsis Salud Mental S.A.
• Estonia
  • Tallinn, Estonia, 11315
    • Marienthali Kliinik
• France
  • Elancourt, France, 78990
    • Centre Medical Ambroise Pare
  • Nantes Cedex 1, France, 44093
    • CHU de Nantes - Hôpital Hôtel Dieu
  • Nord
    • Douai, Nord, France, 59500
      • Cabinet Psyche
• Germany
  • Mainz, Germany, 55122
    • Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri
• Hungary
  • Budapest, Hungary, 1021
    • Vadaskert Alapitvany
  • Gyula, Hungary, 5700
    • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
• Israel
  • Hod Hasharon, Israel, 4534708
    • Shalvata Mental health Center
  • Tel Aviv, Israel, 6435807
    • Ramat Chen - Mental Health Clinic
  • Tel Hashomer, Israel, 5262000
    • The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
• Italy
  • Napoli, Italy, 80131
    • University Federico II of Naples
  • Pisa
    • Calambrone Pisa, Pisa, Italy, 56026
      • Scientific Institute Fondazione Stella Maris
  • Regione Veneto
    • Padova, Regione Veneto, Italy, 35143
      • Sciaf Ulss 16 Padova
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
• Latvia
  • Liepaja, Latvia, LV-3401
    • Linda Keruze's Psychiatric Center, LLC
  • Riga, Latvia, 1079
    • Children Hospilal -Gailezers
• Mexico
  • Chihuahua, Mexico, 31000
    • Icaro Investigaciones en Medicina S.A. de C.V.
  • San Luis Potosi, Mexico, 78213
    • BIND Investigaciones S.C
  • Distrito Federal
    • Ciudad de Mexico, Distrito Federal, Mexico, 04530
      • Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44200
      • Clinica Cemelli
    • Guadalajara, Jalisco, Mexico, 44690
      • Roberto Zepeda Sanchez
    • Guadalajara, Jalisco, Mexico, 44130
      • Centro Investigacion Medico Biologica y Terapia Avanzada
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64060
      • CRI Centro Regiomontano de Investigacion SC
  • Sinaloa
    • Culiacan De Rosales, Sinaloa, Mexico, 80230
      • Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C
    • Mazatlan, Sinaloa, Mexico, 82140
      • B & B Investigaciones Medicas, SC
• Poland
  • Gdansk, Poland, 80-546
    • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Kielce, Poland, 25-103
    • Przychodnia Syntonia Poradnia Zdrowia Psychicznego
  • Lublin, Poland, 20-884
    • Spectrum Centrum Psychiatrii Specjalistyczny Gabinet Psychiatryczny
  • Poznan, Poland, 60-744
    • Filip Rybakowski Specjalistyczna Praktyka Lekarska
  • Walbrzych, Poland, 58300
    • Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15879
      • Prywatne Gabinety Lekarskie PROMEDICUS
• Russian Federation
  • Arkhangelsk, Russian Federation, 163530
    • Arkhangelsk Regional Clinical Mental Hospital
  • Ekaterinburg, Russian Federation, 620030
    • State Budgetary Healthcare Institution of Sverdlovsk Region ¿Sverdlovsk Regional Clinical Psychi...
  • Engels, Russian Federation, 413124
    • GUZ Engels Psychiatric Hospital
  • Krasnodar, Russian Federation, 350007
    • State Budgetary Healthcare Institution (SBHI) Specialized Clinical Psychiatric Hospital 1 of the ...
  • Novosibirsk, Russian Federation, 630091
    • LLC City Neurological Center Sibneuromed
  • Rostov-on-Don, Russian Federation, 344022
    • Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
  • Saratov, Russian Federation, 410028
    • Saratov State Medical University
  • Saratov, Russian Federation, 410060
    • Guz Saratov Regional Psychiatric Hospital St. Sofii
  • St-Petersburg, Russian Federation, 197341
    • City Psychiatric Hospital No.3 named after I.I. Skvortsov-Stepanov
  • Tomsk, Russian Federation, 634009
    • Nebbiolo LLC
  • Yaroslavl, Russian Federation, 150003
    • Yaroslavl Regional Clinical Psychiatry Hospital
  • Rostov State
    • Rostov-On-Don, Rostov State, Russian Federation, 344010
      • Medicorehabilitation Research Center Phoenix
  • Stavropol Region
    • Stavropol, Stavropol Region, Russian Federation, 357034
      • Stavropol Region Psychiatric Hospital No.2
• Serbia
  • Belgrade, Serbia, 11000
    • Institute of Mental Health
  • Belgrade, Serbia, 11000
    • Child and Adolescent Neurology and Psychiatry Clinic
  • Kragujevac, Serbia, 34000
    • University Clinical Center Kragujevac
  • Novi Sad, Serbia, 21000
    • Clinical Center of Vojvodina - Clinic of Psychiatry
  • Pantelej-Nis, Serbia, 18000
    • Daily Hospital for Children and Adolescents
• South Africa
  • Cape Town
    • Bellville, Cape Town, South Africa, 7530
      • Cape Trial Centre
  • Gauteng
    • Sandhurst, Gauteng, South Africa, 2196
      • Tara Hospital
• Spain
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Hospital Universitario Fundacion Alcorcon
  • Malaga
    • Torremolinos, Malaga, Spain, 29620
      • Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo
• Ukraine
  • Kyiv, Ukraine, 04080
    • Ukrainian Research Institute Of Social, Forensic Psychiatry And Drug Abuse, Kiev City Psychoneuro...
  • Odessa, Ukraine, 65006
    • Odessa Regional Medical Centre of Mental Health
  • Poltava, Ukraine, 36013
    • Maltsev Poltava Regional Clinical Psychiatric Hospital, Higher State Educational Institution Of U...
  • Ternopil, Ukraine, 46000
    • Ternopil Regional Clinical Municipal Psycho-Neurological Hospital, Ternopil State Medical Univers...
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group
  • California
    • Imperial, California, United States, 92251
      • Sun Valley Research Center
    • Lemon Grove, California, United States, 91945
      • Synergy Clinical Research Center
    • Long Beach, California, United States, 90807
      • Alliance for Wellness dba Alliance for Research
    • Orange, California, United States, 92868
      • NRC Research Institute
    • Panorama City, California, United States, 91402
      • ASCLEPES Research Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center Merge
  • Florida
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Orange City, Florida, United States, 32763
      • Medical Research Group of Central Florida
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Marietta, Georgia, United States, 30060
      • Northwest Behavioral Research Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • American Medical Research, Inc.
    • Naperville, Illinois, United States, 60563
      • AMR- Baber Research, Inc.
    • Warrenville, Illinois, United States, 60555
      • AMR Conventions Research
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Kansas University School of Medicine-Wichita
  • Louisiana
    • Lake Charles, Louisiana, United States, 70629
      • Lake Charles Clinical Trials
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Kennedy Krieger Institute
  • Missouri
    • Saint Charles, Missouri, United States, 63304
      • St. Charles Psychiatric Associates - Midwest Research Group
    • Saint Louis, Missouri, United States, 63132
      • Millennium Psychiatric Associates, LLC
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Princeton Medical Institute
  • New York
    • New York, New York, United States, 10036
      • Manhattan Behavioral Medicine
    • Rochester, New York, United States, 14618
      • Finger Lakes Clinical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center
    • Cleveland, Ohio, United States, 44012
      • University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry
    • Middleburg Heights, Ohio, United States, 44130
      • North Star Medical Research, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73106
      • IPS Research Company
    • Oklahoma City, Oklahoma, United States, 73118
      • Paradigm Research Professionals, LLC
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Research Strategies of Memphis, LLC
  • Texas
    • Austin, Texas, United States, 78759
      • BioBehavioral Research of Austin
    • Plano, Texas, United States, 75093
      • Research Across America
    • Plano, Texas, United States, 75093
      • AIM Trials, LLC
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
  • Utah
    • Clinton, Utah, United States, 84015
      • WestSide Medical
    • Orem, Utah, United States, 84058
      • Aspen Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Encapsulated tablet, orally
Experimental: Vortioxetine 10 mg/day	Drug: 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; Other Names: Lu AA21004; Brintellix ®
Experimental: Vortioxetine 20 mg/day	Drug: 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; Other Names: Lu AA21004; Brintellix ®
Active Comparator: Fluoxetine 20 mg/day,; A decision has been taken to stop recruitment into this treatment arm.	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 8 of Phase B	The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and 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. The total score ranged from 17 (normal) to 113 (severe depression). Least square (LS) mean was estimated using a restricted maximum likelihood (REML)-based Mixed Model Repeated Measurements (MMRM) approach.	Baseline (Week 4 of Phase A), Week 8 of Phase B

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in CDRS-R Total Score at Weeks 2, 4, and 6 of Phase B	The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and 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. The total score ranged from 17 (normal) to 113 (severe depression).	Baseline (Week 4 of Phase A), Weeks 2, 4, and 6 of Phase B
Change From Baseline in CDRS-R Subscores (Mood, Somatic, Subjective, and Behaviour) at Weeks 2, 4, 6, and 8 of Phase B	The CDRS-R was rated by a clinician following interviews with the child and parent and 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. The total score ranged from 17 (normal) to 113 (severe depression). Four subscores were defined based on the CDRS-R: Mood: sum of items 8, 11, 14, 15; score range 4 to 28, Somatic: sum of items 4, 5, 6, 7, 16, 17; score range 6 to 36, Subjective: sum of items 9, 10, 12, 13; score range 4 to 28, and Behaviour: sum of items 1, 2, 3; score range 3 to 21. Higher scores indicated the most severe measure of depression.	Baseline (Week 4 of Phase A), Weeks 2, 4, 6, and 8 of Phase B
Percentage of Participants With CDRS-R Response	CDRS-R response was defined as a ≥50% decrease in CDRS-R total score, calculated as: (change from baseline [Randomization])/(baseline value - 17). The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and 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. The total score ranged from 17 (normal) to 113 (severe depression).	Weeks 2, 4, 6, and 8 of Phase B
Percentage of Participants With CDRS-R Remission	CDRS-R remission was defined as a CDRS-R total score ≤28. The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and 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. The total score ranged from 17 (normal) to 113 (severe depression).	Weeks 2, 4, 6, and 8 of Phase B
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	The GBI 10-item depression scale was developed to screen for depressive symptoms in children and adolescents. Two versions of the GBI 10-item depression scale were used, the child rated version (CGBI) and the parent rated version (PGBI). The 10 depression items were rated on a 4-point scale from 0 (never or hardly ever) to 3 (very often or almost constantly). The total score ranged from 0 to 30, with higher scores indicating greater pathology.	Baseline (Week 4 of Phase A), Weeks 2, 4, 6, and 8 of Phase B
Parent Global Assessment (PGA) Score	The PGA is a parent-rated variation of the CGI-I to evaluate the severity of the child's symptoms. The PGA reflects assessments of symptoms using a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).	Weeks 2, 4, 6, and 8 of Phase B
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	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).	Baseline (Week 4 of Phase A), Weeks 1, 2, 3, 4, 6, and 8 of Phase B
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).	Weeks 1, 2, 3, 4, 6, and 8 of Phase B
Percentage of Participants With CGI-S Remission	CGI-S remission was defined as a CGI-S score of 1 or 2. 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).	Weeks 1, 2, 3, 4, 6, and 8 of Phase B
Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Weeks 4 and 8 of Phase B	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.	Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
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	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 visual analogue scales. 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. A lower value represents a better outcome.	Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Change From Baseline in PedsQL VAS: Sad or Blue (Sadness) Score at Weeks 4 and 8 of Phase B	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 visual analogue scales. 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. A lower value represents a better outcome.	Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Change From Baseline in PedsQL VAS: Angry Score at Weeks 4 and 8 of Phase B	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 visual analogue scales. 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. A lower value represents a better outcome.	Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Change From Baseline in PedsQL VAS: Worry Score at Weeks 4 and 8 of Phase B	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 visual analogue scales. 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. A lower value represents a better outcome.	Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Change From Baseline in PedsQL VAS: Tired (Fatigue) Score at Weeks 4 and 8 of Phase B	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 visual analogue scales. 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. A lower value represents a better outcome.	Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Change From Baseline in PedsQL VAS: Pain or Hurt Score at Weeks 4 and 8 of Phase B	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 visual analogue scales. 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. A lower value represents a better outcome.	Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Change From Baseline in PedsQL VAS Total Average Score at Weeks 4 and 8 of Phase B	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 visual analogue scales. The functionality for each domain is measured on a 10cm 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. A lower value represents a better outcome.	Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Change From Baseline in PedsQL Emotional Distress Summary Average Score at Weeks 4 and 8 of Phase B	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 visual analogue scales. 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 average emotional distress summary score is the mean of the anxiety, sadness, anger, and worry items. A lower value represents a better outcome.	Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
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	The PQ-LES-Q is a patient-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire, which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1 to 14 assess the degree of satisfaction experienced by participants in various areas of daily functioning, and item 15 allows subjects to summarise their experience in a global rating. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total score range of item 1 to 14 is 14 to 70, with higher scores indicating greater satisfaction.	Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Change From Baseline in PQ-LES-Q Overall Evaluation Score (Item 15) at Weeks 4 and 8 of Phase B	The PQ-LES-Q is a patient-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire, which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1 to 14 assess the degree of satisfaction experienced by participants in various areas of daily functioning, and item 15 allows subjects to summarize their experience in a global rating. Item 15 is rated on a 5-point scale from 1 (very poor) to 5 (very good).	Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2016
• Primary Completion (Actual): January 21, 2022
• Study Completion (Actual): January 21, 2022

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: March 15, 2016
• First Posted (Estimate): March 16, 2016

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: paediatric
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Antagonists; Anti-Anxiety Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Serotonin 5-HT3 Receptor Antagonists; Vortioxetine; Fluoxetine
• Other Study ID Numbers: 12709A; 2008-005353-38 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No