Back to resultsVortioxetine to Prevent Return of Symptoms in Children With Depression
Primary Purpose
Depression
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vortioxetine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria:
De novo patients
- The patient has a primary diagnosis of MDD according to DSM-5™ although co-morbid anxiety disorders will be permitted (except Post Traumatic Stress Disorder (PTSD) and Obsessive Compulsive Disorder (OCD)).
- The patient has a CDRS-R total score ≥45 at the Screening and Baseline Visits.
- The patient has a Clinical Global Impression - Severity of Illness (CGI-S) ≥4 at the Screening and Baseline Visit
Exclusion Criteria:
- The patient receives ongoing current psychotherapy that is planned to be intensified. Interpersonal psychotherapy (IPT) or cognitive behavioural therapy (CBT) are not allowed.
- The patient presents with, or has a history of, an Axis I (DSM-5TM) diagnosis of Bipolar Disorder, PTSD, OCD, Autism, Pervasive Developmental Disorder (PDD), or Schizophrenia or Schizoaffective Disorder.
- The patient has a diagnosis of attention-deficit/hyperactivity disorder (ADHD) and is not maintained on a stable dose of a methylphenidate or amphetamine for a minimum of 4 weeks prior to the study treatment.
- The patient has attempted suicide or is at significant risk of suicide
Other inclusion and exclusion criteria may apply.
Sites / Locations
- Alliance for Research
- Atlanta Center for Medical Research
- AIM Trials, LLC
- 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.
- Linda Keruze's Psychiatric Center, LLC
- CRI Centro Regiomontano de Investigacion SC
- BIND Investigaciones S.C
- SINACOR - Centro para el Desarrollo de la Medicina Y De Asistencia Medica Especializada S.C
- Przychodnia Syntonia Izabela Chojnowska-Cwiakala
- Indywidualna Specjalistyczna Praktyka Lekarska
- Medicorehabilitation Research Center Phoenix
- GUZ Engels Psychiatric Hospital
- Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
- Nebbiolo LLC
- Odessa Regional Psychiatry Hospital No. 2
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Vortioxetine -open label treatment period
Vortioxetine -double-blind relapse prevention period
Placebo -double-blind relapse prevention period
Arm Description
Vortioxetine - 5, 10, 15, and 20 mg/day, film-coated tablets, orally once daily. Patients will receive a targeted dose of 10 mg/day vortioxetine, however the investigator has the possibility to adjust the dose in case of unsatisfactory response or in case of dose-limiting adverse events.
Vortioxetine - 5, 10, 15, and 20 mg/day, encapsulated film-coated tables, orally once daily. In the double-blind period, the patients will continue on the same fixed dose as during the end of the open label period
Placebo - encapsulated tablets, orally once daily.
Outcomes
Primary Outcome Measures
Time to Relapse in the Double-blind Period
Relapse was defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
Secondary Outcome Measures
Relapse Rate in the Double-blind Period: Percentage of Participants With Relapse
Relapse was defined as either a total score ≥40 on the CDRS-R with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
Change From Baseline in Children's Depression Rating Scale - Revised Version (CDRS-R) Total Score at Week 26
The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26
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 at Week 26
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).
Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Week 26
The PQ-LES-Q is a participant-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 participants 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.
Plasma Concentration of Vortioxetine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05014919
Brief Title
Vortioxetine to Prevent Return of Symptoms in Children With Depression
Official Title
A Double-blind, Randomized, Placebo-controlled, Multicentre, Relapse-prevention Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated based on new efficacy data from another study.
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
April 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
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
The purpose of this study is to find out if vortioxetine is better than placebo (sugar pills) in preventing depression in children who improved when treated with vortioxetine.
Detailed Description
The study consists of a 12-week open-label, flexible-dose treatment period with vortioxetine, followed by a 26-week, randomized, double-blind, fixed-dose, placebo-controlled relapse-prevention period. There will be a safety follow up 4 weeks after the end of the 26-week double-blind treatment period.
The study population will include 'de novo' participants as well as 'rollover' participants from other paediatric vortioxetine studies 12709A (NCT02709655) and 12712A (NCT02871297), who, in the investigator's opinion, could benefit from continued treatment with vortioxetine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vortioxetine -open label treatment period
Arm Type
Experimental
Arm Description
Vortioxetine - 5, 10, 15, and 20 mg/day, film-coated tablets, orally once daily.
Patients will receive a targeted dose of 10 mg/day vortioxetine, however the investigator has the possibility to adjust the dose in case of unsatisfactory response or in case of dose-limiting adverse events.
Arm Title
Vortioxetine -double-blind relapse prevention period
Arm Type
Experimental
Arm Description
Vortioxetine - 5, 10, 15, and 20 mg/day, encapsulated film-coated tables, orally once daily.
In the double-blind period, the patients will continue on the same fixed dose as during the end of the open label period
Arm Title
Placebo -double-blind relapse prevention period
Arm Type
Placebo Comparator
Arm Description
Placebo - encapsulated tablets, orally once daily.
Intervention Type
Drug
Intervention Name(s)
Vortioxetine
Other Intervention Name(s)
Brintellix, Trintellix
Intervention Description
Tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets
Primary Outcome Measure Information:
Title
Time to Relapse in the Double-blind Period
Description
Relapse was defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
Time Frame
From randomization to Week 26 in the double-blind treatment period
Secondary Outcome Measure Information:
Title
Relapse Rate in the Double-blind Period: Percentage of Participants With Relapse
Description
Relapse was defined as either a total score ≥40 on the CDRS-R with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
Time Frame
From randomization to Week 26 in the double-blind treatment period
Title
Change From Baseline in Children's Depression Rating Scale - Revised Version (CDRS-R) Total Score at Week 26
Description
The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
Time Frame
Baseline, Week 26
Title
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26
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 26
Title
Clinical Global Impression - Global Improvement (CGI-I) Score at Week 26
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
Week 26
Title
Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Week 26
Description
The PQ-LES-Q is a participant-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 participants 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 26
Title
Plasma Concentration of Vortioxetine
Time Frame
From randomization to Week 26 in the double-blind treatment period
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:
De novo participants
The participant has a primary diagnosis of MDD according to DSM-5™ although co-morbid anxiety disorders will be permitted (except Post Traumatic Stress Disorder (PTSD) and Obsessive Compulsive Disorder (OCD)).
The participant has a CDRS-R total score ≥45 at the Screening and Baseline Visits.
The participant has a Clinical Global Impression - Severity of Illness (CGI-S) ≥4 at the Screening and Baseline Visit
Exclusion Criteria:
The participant receives ongoing current psychotherapy that is planned to be intensified. Interpersonal psychotherapy (IPT) or cognitive behavioural therapy (CBT) are not allowed.
The participant presents with, or has a history of, an Axis I (DSM-5TM) diagnosis of Bipolar Disorder, PTSD, OCD, Autism, Pervasive Developmental Disorder (PDD), or Schizophrenia or Schizoaffective Disorder.
The participant has a diagnosis of attention-deficit/hyperactivity disorder (ADHD) and is not maintained on a stable dose of a methylphenidate or amphetamine for a minimum of 4 weeks prior to the study treatment.
The participant has attempted suicide or is at significant risk of suicide
Other 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
Alliance for Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
AIM Trials, LLC
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
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
ZIP/Postal Code
660001
Country
Colombia
Facility Name
Linda Keruze's Psychiatric Center, LLC
City
Liepaja
ZIP/Postal Code
3401
Country
Latvia
Facility Name
CRI Centro Regiomontano de Investigacion SC
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64060
Country
Mexico
Facility Name
BIND Investigaciones S.C
City
San Luis Potosi
State/Province
San Luis Potosí
ZIP/Postal Code
78213
Country
Mexico
Facility Name
SINACOR - 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
Przychodnia Syntonia Izabela Chojnowska-Cwiakala
City
Kielce
ZIP/Postal Code
25-103
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska
City
Poznan
ZIP/Postal Code
60744
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
GUZ Engels Psychiatric Hospital
City
Engels
ZIP/Postal Code
413124
Country
Russian Federation
Facility Name
Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
City
Rostov-on-Don
ZIP/Postal Code
344002
Country
Russian Federation
Facility Name
Nebbiolo LLC
City
Tomsk
ZIP/Postal Code
634009
Country
Russian Federation
Facility Name
Odessa Regional Psychiatry Hospital No. 2
City
Odessa
ZIP/Postal Code
65128
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Vortioxetine to Prevent Return of Symptoms in Children With Depression
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