Back to resultsActive Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)
Primary Purpose
Depressive Disorder, Major
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vortioxetine 10 mg/day
Vortioxetine 20 mg/day
Fluoxetine 20mg/day
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring paediatric
Eligibility Criteria
Inclusion Criteria:
- The participant has MDD, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5™).
- The participant has a CDRS-R total score ≥45 at the Screening Visit and the Baseline.
- The participant has a CGI-S score ≥4 at the Screening Visit and the Baseline.
- The participant is a boy or girl, aged ≥7 and <12 years at Screening Visit
- The participant has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.
Exclusion Criteria:
- The participant has participated in a clinical study <30 days prior to the Screening Visit.
- The participant has previously participated in a study with vortioxetine.
Other protocol defined inclusion and exclusion criteria may apply
Sites / Locations
- Woodland International Research Group
- Sun Valley Research Center
- Synergy Clinical Research Center
- Alliance for Wellness dba Alliance for Research
- NRC Research Institute
- Asclepes Research Center
- Children's National Medical Center Merge
- Sarkis Clinical Trials
- Medical Research Group of Central Florida
- Atlanta Center for Medical Research
- Northwest Behavioral Research Center
- American Medical Research, Inc.
- AMR- Baber Research, Inc.
- AMR Conventions Research
- Kansas University School of Medicine-Wichita
- Lake Charles Clinical Trials
- Kennedy Krieger Institute
- St. Charles Psychiatric Associates - Midwest Research Group
- Millennium Psychiatric Associates, LLC
- Princeton Medical Institute
- Manhattan Behavioral Medicine
- Finger Lakes Clinical Research
- University of Cincinnati Medical Center
- University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry
- North Star Medical Research, LLC
- IPS Research Company
- Paradigm Research Professionals, LLC
- Research Strategies Of Memphis, Llc
- BioBehavioral Research of Austin
- AIM Trials, LLC
- Research Across America
- Clinical Trials of Texas, Inc.
- Westside Medical
- Aspen Clinical Research, LLC
- 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
- Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri
- Vadaskert Alapitvany
- Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
- Shalvata Mental Health Center
- Ramat Chen - Mental Health Clinic
- The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
- Scientific Institute Fondazione Stella Maris
- Sciaf Ulss 16 Padova
- University Federico II Of Naples
- Seoul National University Hospital
- Linda Keruze's Psychiatric Center, LLC
- Children Hospilal -Gailezers
- Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)
- Centro Investigacion Medico Biologica Y Terapia Avanzada
- 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
- ICARO Investigaciones en Medicina S.A. de C.V.
- 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
- 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 ...
- 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
- Tara Hospital
- Hospital Universitario Fundacion Alcorcon
- Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo
- 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...
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
Vortioxetine 10 mg/day
Vortioxetine 20 mg/day
Fluoxetine 20 mg/day,
Placebo
Arm Description
A decision has been taken to stop recruitment into this treatment arm.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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).
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).
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.
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
Full Information
NCT ID
NCT02709655
First Posted
March 11, 2016
Last Updated
August 29, 2022
Sponsor
H. Lundbeck A/S
Collaborators
Takeda
1. Study Identification
Unique Protocol Identification Number
NCT02709655
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 18, 2016 (Actual)
Primary Completion Date
January 21, 2022 (Actual)
Study Completion Date
January 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
Collaborators
Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
paediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
683 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vortioxetine 10 mg/day
Arm Type
Experimental
Arm Title
Vortioxetine 20 mg/day
Arm Type
Experimental
Arm Title
Fluoxetine 20 mg/day,
Arm Type
Active Comparator
Arm Description
A decision has been taken to stop recruitment into this treatment arm.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Vortioxetine 10 mg/day
Other Intervention Name(s)
Brintellix ®, Lu AA21004
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Vortioxetine 20 mg/day
Other Intervention Name(s)
Brintellix ®, Lu AA21004
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Fluoxetine 20mg/day
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Encapsulated tablet, orally
Primary Outcome Measure Information:
Title
Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 8 of Phase B
Description
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.
Time Frame
Baseline (Week 4 of Phase A), Week 8 of Phase B
Secondary Outcome Measure Information:
Title
Change From Baseline in CDRS-R Total Score at Weeks 2, 4, and 6 of Phase B
Description
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).
Time Frame
Baseline (Week 4 of Phase A), Weeks 2, 4, and 6 of Phase B
Title
Change From Baseline in CDRS-R Subscores (Mood, Somatic, Subjective, and Behaviour) at Weeks 2, 4, 6, and 8 of Phase B
Description
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.
Time Frame
Baseline (Week 4 of Phase A), Weeks 2, 4, 6, and 8 of Phase B
Title
Percentage of Participants With CDRS-R Response
Description
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).
Time Frame
Weeks 2, 4, 6, and 8 of Phase B
Title
Percentage of Participants With CDRS-R Remission
Description
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).
Time Frame
Weeks 2, 4, 6, and 8 of Phase B
Title
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
Description
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.
Time Frame
Baseline (Week 4 of Phase A), Weeks 2, 4, 6, and 8 of Phase B
Title
Parent Global Assessment (PGA) Score
Description
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).
Time Frame
Weeks 2, 4, 6, and 8 of Phase B
Title
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
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).
Time Frame
Baseline (Week 4 of Phase A), Weeks 1, 2, 3, 4, 6, and 8 of Phase B
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).
Time Frame
Weeks 1, 2, 3, 4, 6, and 8 of Phase B
Title
Percentage of Participants With CGI-S Remission
Description
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).
Time Frame
Weeks 1, 2, 3, 4, 6, and 8 of Phase B
Title
Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Weeks 4 and 8 of Phase B
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 4 of Phase A), Weeks 4 and 8 of Phase B
Title
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
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 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.
Time Frame
Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Title
Change From Baseline in PedsQL VAS: Sad or Blue (Sadness) Score at Weeks 4 and 8 of Phase B
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 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.
Time Frame
Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Title
Change From Baseline in PedsQL VAS: Angry Score at Weeks 4 and 8 of Phase B
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 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.
Time Frame
Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Title
Change From Baseline in PedsQL VAS: Worry Score at Weeks 4 and 8 of Phase B
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 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.
Time Frame
Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Title
Change From Baseline in PedsQL VAS: Tired (Fatigue) Score at Weeks 4 and 8 of Phase B
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 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.
Time Frame
Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Title
Change From Baseline in PedsQL VAS: Pain or Hurt Score at Weeks 4 and 8 of Phase B
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 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.
Time Frame
Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Title
Change From Baseline in PedsQL VAS Total Average Score at Weeks 4 and 8 of Phase B
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 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.
Time Frame
Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Title
Change From Baseline in PedsQL Emotional Distress Summary Average Score at Weeks 4 and 8 of Phase B
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 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.
Time Frame
Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Title
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
Description
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.
Time Frame
Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
Title
Change From Baseline in PQ-LES-Q Overall Evaluation Score (Item 15) at Weeks 4 and 8 of Phase B
Description
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).
Time Frame
Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The participant has MDD, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5™).
The participant has a CDRS-R total score ≥45 at the Screening Visit and the Baseline.
The participant has a CGI-S score ≥4 at the Screening Visit and the Baseline.
The participant is a boy or girl, aged ≥7 and <12 years at Screening Visit
The participant has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.
Exclusion Criteria:
The participant has participated in a clinical study <30 days prior to the Screening Visit.
The participant has previously participated in a study with vortioxetine.
Other protocol defined inclusion and exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Sun Valley Research Center
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Facility Name
Synergy Clinical Research Center
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Alliance for Wellness dba Alliance for Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Asclepes Research Center
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Children's National Medical Center Merge
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Medical Research Group of Central Florida
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Northwest Behavioral Research Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
American Medical Research, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
AMR- Baber Research, Inc.
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
AMR Conventions Research
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
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
Lake Charles Clinical Trials
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
St. Charles Psychiatric Associates - Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Millennium Psychiatric Associates, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63132
Country
United States
Facility Name
Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Manhattan Behavioral Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
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
North Star Medical Research, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
Paradigm Research Professionals, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Research Strategies Of Memphis, Llc
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
BioBehavioral Research of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
AIM Trials, LLC
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Research Across America
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Westside Medical
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Aspen Clinical Research, LLC
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
MHAT Targovishte AD
City
Targovisthe
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
Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri
City
Mainz
ZIP/Postal Code
55122
Country
Germany
Facility Name
Vadaskert Alapitvany
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
Shalvata Mental Health Center
City
Hod Hasharon
ZIP/Postal Code
4534708
Country
Israel
Facility Name
Ramat Chen - Mental Health Clinic
City
Tel Aviv
ZIP/Postal Code
6435807
Country
Israel
Facility Name
The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
City
Tel Hashomer
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Scientific Institute Fondazione Stella Maris
City
Calambrone Pisa
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
University Federico II Of Naples
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
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
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
Centro Investigacion Medico Biologica Y Terapia Avanzada
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
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
64060
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
ICARO Investigaciones en Medicina S.A. de C.V.
City
Chihuahua
ZIP/Postal Code
31000
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
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
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
Tara Hospital
City
Sandhurst
State/Province
Gauteng
ZIP/Postal Code
2196
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
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
12. IPD Sharing Statement
Learn more about this trial
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)
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