Clinical Trial Results:
Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 18 Years of Age
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Summary
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EudraCT number |
2008-005356-25 |
Trial protocol |
LV DE HU PL IT ES BG BE |
Global end of trial date |
19 Apr 2022
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Results information
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Results version number |
v1 |
This version publication date |
04 Oct 2022
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First version publication date |
04 Oct 2022
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Other versions |
v2 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
12712A
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02871297 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
H. Lundbeck A/S
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Sponsor organisation address |
Ottiliavej 9, Valby, Denmark, 2500
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Public contact |
LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@lundbeck.com
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Scientific contact |
LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@lundbeck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000455-PIP02-10 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Apr 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
25 Mar 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Apr 2022
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The primary objective of the trial was to evaluate the long-term safety and tolerability of vortioxetine in child and adolescent participants with a Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5®) diagnosis of MDD.
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Protection of trial subjects |
This study was conducted in compliance with Good Clinical Practice and in accordance with the ethical principles described in the Declaration of Helsinki.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
17 Aug 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Bulgaria: 43
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Country: Number of subjects enrolled |
Canada: 5
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Country: Number of subjects enrolled |
Colombia: 105
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Country: Number of subjects enrolled |
Germany: 12
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Country: Number of subjects enrolled |
Spain: 11
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Country: Number of subjects enrolled |
Estonia: 26
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Country: Number of subjects enrolled |
France: 14
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Country: Number of subjects enrolled |
United Kingdom: 5
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Country: Number of subjects enrolled |
Hungary: 8
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Country: Number of subjects enrolled |
Israel: 1
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Country: Number of subjects enrolled |
Italy: 15
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Country: Number of subjects enrolled |
Korea, Republic of: 4
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Country: Number of subjects enrolled |
Latvia: 31
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Country: Number of subjects enrolled |
Mexico: 104
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Country: Number of subjects enrolled |
Poland: 69
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Country: Number of subjects enrolled |
Russian Federation: 136
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Country: Number of subjects enrolled |
Serbia: 37
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Country: Number of subjects enrolled |
Ukraine: 20
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Country: Number of subjects enrolled |
United States: 14
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Country: Number of subjects enrolled |
South Africa: 2
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Worldwide total number of subjects |
662
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EEA total number of subjects |
229
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
300
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Adolescents (12-17 years) |
352
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Adults (18-64 years) |
10
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
This was a long-term extension study in child and adolescent participants with MDD who completed 1 of the double-blind, placebo-controlled, active-reference Study 12709A (NCT02709655) or 12710A (NCT02709746). | ||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||||
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Arms
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Arm title
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Vortioxetine | ||||||||||||||||||||||||||
Arm description |
Participants initiated treatment with vortioxetine 5 milligrams (mg)/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting adverse events (AEs), vortioxetine dose could be up- or down-titrated with 5 mg/day but the maximum dose did not exceed 20 mg/day. The total duration of treatment was 26 weeks. | ||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||
Investigational medicinal product name |
Vortioxetine
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Investigational medicinal product code |
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Other name |
Brintellix ®, Lu AA21004
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Pharmaceutical forms |
Oral drops, solution, Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Vortioxetine was administered per dose and schedule specified in the arm description.
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Baseline characteristics reporting groups
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Reporting group title |
Vortioxetine
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Reporting group description |
Participants initiated treatment with vortioxetine 5 milligrams (mg)/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting adverse events (AEs), vortioxetine dose could be up- or down-titrated with 5 mg/day but the maximum dose did not exceed 20 mg/day. The total duration of treatment was 26 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Vortioxetine
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Reporting group description |
Participants initiated treatment with vortioxetine 5 milligrams (mg)/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting adverse events (AEs), vortioxetine dose could be up- or down-titrated with 5 mg/day but the maximum dose did not exceed 20 mg/day. The total duration of treatment was 26 weeks. | ||
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End point title |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [1] | ||||||
End point description |
An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAE was defined as an AE that started or increased in intensity on or after the date of first dose of study drug in this study 12712A. A summary of serious and non-serious AEs regardless of causality is located in ‘Reported Adverse Events module’. All-patients-treated set (APTS) included all participants who took at least 1 dose of vortioxetine in this study 12712A.
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End point type |
Primary
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End point timeframe |
Baseline up to Week 30
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Analysis was descriptive in nature. |
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| No statistical analyses for this end point | |||||||
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End point title |
Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 26 | ||||||||
End point description |
CDRS-R 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. Total score ranged from 17 (normal) to 113 (severe depression). Least square (LS) mean was calculated using using a restricted maximum likelihood-based mixed model for repeated measurements (MMRM) approach. Full analysis set (FAS) included all participants who took at least 1 dose of vortioxetine in this study 12712A with valid open-label extension baseline (OLEXA) assessment and at least 1 valid post-OLEXA assessment of the CDRS-R total score. Here, 'overall number of participants analyzed' signifies participants evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 26
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to First Relapse | ||||||||
End point description |
Relapse was defined as a total score ≥40 on the CDRS-R. CDRS-R 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. Total score ranged from 17 (normal) to 113 (severe depression). Due to change in planned analysis, this endpoint was not analyzed; hence, data were not collected for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline up to Week 26
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| Notes [2] - Due to change in planned analysis, this endpoint was not analyzed. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to First Loss of Remission | ||||||||
End point description |
Remission was defined as a total score ≤28 on the CDRS-R. CDRS-R 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. Total score ranged from 17 (normal) to 113 (severe depression). Due to change in planned analysis, this endpoint was not analyzed; hence, data were not collected for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline up to Week 26
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| Notes [3] - Due to change in planned analysis, this endpoint was not analyzed. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26 | ||||||||
End point 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). LS mean was calculated using using a restricted maximum likelihood-based MMRM approach. FAS included all participants who took at least 1 dose of vortioxetine in this study 12712A with valid OLEXA assessment and at least 1 valid post-OLEXA assessment of the CDRS-R total score. Here, 'overall number of participants analyzed' signifies participants evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 26
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| No statistical analyses for this end point | |||||||||
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End point title |
Clinical Global Impression - Global Improvement (CGI-I) Score | ||||||||
End point 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). LS mean was calculated using using a restricted maximum likelihood-based MMRM approach. FAS included all participants who took at least 1 dose of vortioxetine in this study 12712A with valid OLEXA assessment and at least 1 valid post-OLEXA assessment of the CDRS-R total score. Here, 'overall number of participants analyzed' signifies participants evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Week 26
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| No statistical analyses for this end point | |||||||||
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End point title |
Children (7-11 Years): Change From Baseline in Behaviour Rating Inventory of Executive Function - Preschool (BRIEF-P) Using the Global Executive Composite Score at Week 26 | ||||||||
End point description |
The BRIEF-P is an 86 item measure that assesses impairment in executive function with symptoms rated on a 3-point likert scale of 1 "never", 2 "sometimes" or 3 "often". There are 8 clinical sub-scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor) and two validity scales (Inconsistency and Negativity). A Global Executive Composite score is obtained by summing all 8 clinical sub-scales. The Global Executive Composite ranges from 86-258 with higher scores indicating greater impairment in executive functions. The Global Executive Composite gets converted to a T-score with T-scores of 65 or above considered in the clinical range. FAS included all participants who took at least 1 dose of vortioxetine in this study 12712A with valid OLEXA assessment and at least 1 valid post-OLEXA assessment of the CDRS-R total score. Here, 'overall number of participants analyzed' signifies participants evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 26
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| No statistical analyses for this end point | |||||||||
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End point title |
Adolescents (12-18 Years): Change From Baseline in Behaviour Rating Inventory of Executive Function - Self-report (BRIEF-SR) Using the Global Executive Composite Score at Week 26 | ||||||||
End point description |
The BRIEF-SR is an 86 item measure that assesses impairment in executive function with symptoms rated on a 3-point likert scale of 1 "never", 2 "sometimes" or 3 "often". There are 8 clinical sub-scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor) and two validity scales (Inconsistency and Negativity). A Global Executive Composite score is obtained by summing all 8 clinical sub-scales. The Global Executive Composite ranges from 86-258 with higher scores indicating greater impairment in executive functions. The Global Executive Composite gets converted to a T-score with T-scores of 65 or above considered in the clinical range. FAS included all participants who took at least 1 dose of vortioxetine in this study 12712A with valid OLEXA assessment and at least 1 valid post-OLEXA assessment of the CDRS-R total score. Here, 'overall number of participants analyzed' signifies participants evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 26
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| No statistical analyses for this end point | |||||||||
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End point title |
Children (7-11 Years): Change From Baseline in BRIEF-P Using the Metacognition Index Score at Week 26 | ||||||||
End point description |
The BRIEF-P is an 86 item measure that assesses impairment in executive function with symptoms rated on a 3-point likert scale of 1 "never", 2 "sometimes" or 3 "often". There are 8 clinical sub-scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor) and two validity scales (Inconsistency and Negativity). The Metacognition Index (initiate, working memory, plan/organize, organisation of materials, and monitor) score is the total of 44 items and ranges from 44 to 132 with lower scores reflecting better functioning. FAS included all participants who took at least 1 dose of vortioxetine in this study 12712A with valid OLEXA assessment and at least 1 valid post-OLEXA assessment of the CDRS-R total score. Here, 'overall number of participants analyzed' signifies participants evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 26
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| No statistical analyses for this end point | |||||||||
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End point title |
Adolescents (12-18 Years): Change From Baseline in BRIEF-SR Using the Metacognition Index Score at Week 26 | ||||||||
End point description |
The BRIEF-SR is an 86 item measure that assesses impairment in executive function with symptoms rated on a 3-point likert scale of 1 "never", 2 "sometimes" or 3 "often". There are 8 clinical sub-scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor) and two validity scales (Inconsistency and Negativity). The Metacognition Index (initiate, working memory, plan/organize, organisation of materials, and monitor) score is the total of 44 items and ranges from 44 to 132 with lower scores reflecting better functioning. FAS included all participants who took at least 1 dose of vortioxetine in this study 12712A with valid OLEXA assessment and at least 1 valid post-OLEXA assessment of the CDRS-R total score. Here, 'overall number of participants analyzed' signifies participants evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 26
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Week 26 | ||||||||
End point 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. FAS included all participants who took at least 1 dose of vortioxetine in this study 12712A with valid OLEXA assessment and at least 1 valid post-OLEXA assessment of the CDRS-R total score. Here, 'overall number of participants analyzed' signifies participants evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 26
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scale (PedsQL VAS) Total Score at Week 26 | ||||||||
End point 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 VAS. 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 total score is the average of all 6 items. A lower value represents a better outcome. FAS included all participants who took at least 1 dose of vortioxetine in this study 12712A with valid OLEXA assessment and at least 1 valid post-OLEXA assessment of the CDRS-R total score. Here, 'overall number of participants analyzed' signifies participants evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 26
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Participants With Response to the Palatability Questionnaire | ||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The palatability of vortioxetine oral drops was assessed after intake of a single dose (5 to 20 mg) corresponding to the participant’s current vortioxetine dose (replacing the vortioxetine tablet on that day). The palatability assessment included 4 questions on the overall appreciation of a medicinal product in relation to its taste (What do you think of the taste), mouthfeel (How does medicine feel in your mouth), aftertaste (What do you think of the after taste), and smell (What do you think of the smell). The items were rated on a 5-point hedonic scale; really bad, bad, neither good or bad, good, or very good. The oral drops were considered acceptable if the mean hedonic scores were ≤3 for each aspect of palatability (taste, aftertaste, smell, and mouthfeel). APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A. Here, 'overall number of participants analyzed' signifies participants evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline up to Week 26
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of Participants With Response to the Acceptability Questionnaire | ||||||||||||||||||||||||
End point description |
The acceptability of vortioxetine oral drops was assessed after intake of a single dose (5 to 20 mg) corresponding to the participant’s current vortioxetine dose (replacing the vortioxetine tablet on that day). The acceptability assessment was based on 3 items; acceptability of the taste, whether the drops were perceived as easy to take, willingness to take the drops every day (provided it was the only available formulation). For each item the response options were no, not sure, and yes. The oral drops were considered acceptable if <60% of participants responded "no" to each of the 3 questions regarding acceptability. APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A. Here, 'overall number of participants analyzed' signifies participants evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline up to Week 26
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Baseline up to Week 30
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Adverse event reporting additional description |
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.0
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Reporting groups
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Reporting group title |
Vortioxetine
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Reporting group description |
Participants initiated treatment with vortioxetine 5 mg/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting AEs, vortioxetine dose could be up- or down-titrated with 5 mg/day but the maximum dose did not exceed 20 mg/day. The total duration of treatment was 26 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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16 Jan 2017 |
Addition of efficacy assessments of the depressive symptoms by using CDRS-R at all study visits, scheduled and unscheduled. Pharmacokinetic (PK) sampling was also added at visits where clinical laboratory samples were collected, in order to evaluate compliance using population PK analysis. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| The study was terminated early based on new efficacy data from another study. | |||
