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Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 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 20 mg/day
Placebo
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring paediatric patients

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient is a male or female, aged ≥12 and ≤17 years at Screening (patients who turn 18 years during the study will be allowed to continue in the study).
  • The patient has Major depressive disorder (MDD), diagnosed according to DSM-5™.
  • The patient has a Children Depression Rating Scale - Revised (CDRS-R) total score ≥45 at the Screening Visit and at the Baseline.
  • The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≥4 at the Screening Visit and at the Baseline
  • The patient has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.

Exclusion Criteria:

  • The patient has participated in a clinical study <30 days prior to the Screening Visit.

Other protocol defined inclusion and exclusion criteria may apply

Sites / Locations

  • US1369
  • US1333
  • US1310
  • US1062
  • US1387
  • US1114
  • US1118
  • US1123
  • US1160 Renew Behavioral Health, Inc.
  • US1368
  • US1370
  • US1351
  • US1133
  • US1217
  • US1229
  • US1009
  • US1313
  • US1311
  • US1315
  • US1103
  • US1386
  • US1261
  • US1015
  • US1385 Ericksen Research And Development
  • US1064
  • US1314
  • US1266
  • US1312
  • US1222
  • US1317
  • US1171
  • US1190
  • US1051
  • US1054
  • US1334
  • US1323
  • US1329
  • US1328
  • US1320
  • US1162
  • US1308
  • US1309
  • BG1023
  • BG1025
  • CA1036 University of Calgary
  • CA1038
  • CO1003
  • CO1001
  • CO1004
  • CO1002
  • EE1007
  • EE1015
  • FR1041
  • FR1017
  • FR1009
  • DE1078
  • DE1034
  • DE1077
  • DE1081
  • DE1076
  • HU1023
  • HU1020
  • IT1075
  • IT1073
  • IT1029
  • IT1068
  • IT1074
  • IT1070
  • IT1072 Osppedale Bambin gesu
  • KR1035
  • UA1037
  • KR1032
  • KR1038
  • LV1002
  • LV1008
  • LV1009
  • LV1007
  • MX1003
  • MX1014
  • MX1011
  • MX1013
  • MX1022
  • MX1023
  • MX1001
  • PL1002
  • PL1050
  • PL1068
  • PL1057
  • PL1052
  • PL1051
  • PL1054
  • RU1009
  • RU1016
  • RU1059
  • RU1046
  • RU1011
  • RU1004
  • RU1010
  • RU1012
  • RU1044
  • RU1013
  • RU1038
  • RU1030
  • RU1057
  • RU1048
  • RS1006 Clinic of Neurology and Psychiatry for Children and Adolescents
  • RS1010
  • RS1011
  • RS1003
  • RS1007
  • ZA1019
  • ZA1022
  • ZA1023
  • ES1041
  • ES1044
  • ES1043
  • ES1018 Hospital de Sabadell
  • ES1040
  • UA1002
  • UA1019
  • UA1001
  • UA1004
  • GB1051
  • GB1047

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

Outcomes

Primary Outcome Measures

Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment
The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression).

Secondary Outcome Measures

Change in CDRS-R Total Score During Treatment (at Week 2)
The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression).Children and parents answer separately. Rater judges and selects 'Best'.
Change in CDRS-R Total Score During Treatment (at Week 4)
The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression).
Change in CDRS-R Total Score During Treatment (at Week 6)
The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression).
Change in CDRS-R Mood Score
Change in Children Depression Rating Scale - Revised (CDRS-R) Mood. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. Mood is one of four subscores defined in the CDRS-R: sum of items 8, 11, 14, 15; score range 4 to 28. The highest possible score indicates the most severe measure of depression.
Change in CDRS-R Somatic Score
Change in Children Depression Rating Scale - Revised (CDRS-R): Somatic. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. Somatic is one of four subscores defined in the CDRS-R: sum of items 4, 5, 6, 7, 16, 17; score ranges from 6 to 36. The highest possible score indicates the most severe measure of depression.
Change in CDRS-R Subjective Score
Change in Children Depression Rating Scale - Revised (CDRS-R): Subjective. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. Subjective is one of four subscores defined in the CDRS-R: sum of items 9, 10, 12, 13; score ranges from 4 to 28. The highest possible score indicates the most severe measure of depression.
Change in CDRS-R Behaviour Score
Change in Children Depression Rating Scale - Revised (CDRS-R): Behaviour. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. behaviour is one of four subscores defined in the CDRS-R:sum of items 1, 2, 3; score ranges from 3 to 21. The highest possible score indicates the most severe measure of depression.
CDRS-R Response
Children Depression Rating Scale - Response: defined as a >= 50% decrease in CDRS-R total score, calculated as (change from baseline [Randomization])/(baseline value - 17).
CDRS-R Remission
Remission is defined as a CDRS-R total score <= 28.
Change in General Behaviour Inventory (GBI) Depression Sub Scale Score Assessed by the Parents
Using the 10-item depression subscale, assessed by parent (PGBI-10D). Change from randomization to Week 8 in GBI Total Parent/Guardian Version Depression score. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.
Change General Behaviour Inventory (GBI) Depression Subscale Score Assessed by the Child
The GBI 10-item mania scale is a parent- and subject-rated scale designed to screen for manic symptoms in children and adolescents. The 10 items are rated on a scale from 0 (never or hardly ever) to 3 (very often or almost constantly). The total score ranges from 0 to 30 points, with high scores indicating greater pathology.
Parent Global Assessment-Global Improvement (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 change from Baseline symptoms using a 7 point scale ranging from 1 (very much improved) to 7 (very much worse).
Change in Symbol Digit Modalities Test (SDMT)
The Symbol Digit Modalities Test (SDMT) is a cognitive test designed to assess speed of performance requiring visual perception, spatial decision-making and psychomotor skills. The SDMT consists of 110 geometric symbols that the patient has to substitute with a corresponding digit in a 90-second period. Each correct digit is counted, and the total score ranges from 0 (less than normal functioning) to 110 (greater than normal functioning).
Change in Clinical Global Impression Severity of Illness (CGI-S) Score
The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
Clinical Global Impression - Global Improvement (CGI-I) Score
The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not.
CGI-S Remission
Remission defined as CGI-S score of 1 or 2.
Change in Children's Global Assessment Scale (CGAS) Score
The Children's Global Assessment Score (CGAS) is a rating scale which measures psychological, social and school functioning for children. 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 items range in value from 1 (most functionally impaired child) to 100 (the healthiest). A total score above 70 indicates normal function.
Change in Pediatric Quality of Life Inventory (PedsQL) Visual Analogue Scales (VAS): Afraid or Scared (Anxiety) Score
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 patients are asked to mark on the line how they feel. A lower value represents a better outcome.
Change in PedsQL VAS: Sad or Blue (Sadness) Score
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 patients are asked to mark on the line how they feel. A lower value represents a better outcome.
Change in PedsQL VAS: Angry Score
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 patients are asked to mark on the line how they feel. A lower value represents a better outcome.
Change in PedsQL VAS: Worry Score
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 patients are asked to mark on the line how they feel. A lower value represents a better outcome.
Change in PedsQL VAS: Tired (Fatigue) Score
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 patients are asked to mark on the line how they feel. A lower value represents a better outcome.
Change in PedsQL VAS: Pain or Hurt Score
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 patients are asked to mark on the line how they feel. A lower value represents a better outcome.
Change in PedsQL VAS Total Average Score
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 patients 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 in PedsQL Emotional Distress Summary Average Score
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 patients 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 in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Scores
PQ-LES-Q total score (items 1 to 14). 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 (Q-LES-Q), which is used to measure quality of life in adults. The PQ LES Q consist of 15 items, item 1-14 assess the degree of satisfaction experienced by subjects in various areas of daily functioning (and item 15 allows subjects to summarize 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 1-14 (this outcome measurement) is 14 to 70, with higher scores indicating greater satisfaction.
Change in PQ-LES-Q Overall Score
PQ-LES-Q overall evaluation score (item 15). 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 (Q-LES-Q), which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1-14 assess the degree of satisfaction experienced by subjects in various areas of daily functioning and item 15 allows subjects to summarize their experience in a global rating (this outcome measurement). Item 15 is rated on a 5-point scale from 1 (very poor) to 5 (very good).

Full Information

First Posted
March 11, 2016
Last Updated
August 4, 2020
Sponsor
H. Lundbeck A/S
Collaborators
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT02709746
Brief Title
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)
Official Title
Interventional, Randomised, Double-blind, Placebo-controlled, Active Reference (Fluoxetine), Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years, With Major Depressive Disorder (MDD)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
July 2, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
Collaborators
Takeda

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
paediatric patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
784 (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 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 (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 (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 20 mg/day
Intervention Description
20 mg/day, encapsulated tablet (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
Primary Outcome Measure Information:
Title
Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment
Description
The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression).
Time Frame
From Randomization to Week 8
Secondary Outcome Measure Information:
Title
Change in CDRS-R Total Score During Treatment (at Week 2)
Description
The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression).Children and parents answer separately. Rater judges and selects 'Best'.
Time Frame
At week 2
Title
Change in CDRS-R Total Score During Treatment (at Week 4)
Description
The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression).
Time Frame
At week 4
Title
Change in CDRS-R Total Score During Treatment (at Week 6)
Description
The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression).
Time Frame
At week 6
Title
Change in CDRS-R Mood Score
Description
Change in Children Depression Rating Scale - Revised (CDRS-R) Mood. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. Mood is one of four subscores defined in the CDRS-R: sum of items 8, 11, 14, 15; score range 4 to 28. The highest possible score indicates the most severe measure of depression.
Time Frame
From randomization to Week 8
Title
Change in CDRS-R Somatic Score
Description
Change in Children Depression Rating Scale - Revised (CDRS-R): Somatic. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. Somatic is one of four subscores defined in the CDRS-R: sum of items 4, 5, 6, 7, 16, 17; score ranges from 6 to 36. The highest possible score indicates the most severe measure of depression.
Time Frame
From Randomization to Week 8
Title
Change in CDRS-R Subjective Score
Description
Change in Children Depression Rating Scale - Revised (CDRS-R): Subjective. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. Subjective is one of four subscores defined in the CDRS-R: sum of items 9, 10, 12, 13; score ranges from 4 to 28. The highest possible score indicates the most severe measure of depression.
Time Frame
From Randomization to Week 8
Title
Change in CDRS-R Behaviour Score
Description
Change in Children Depression Rating Scale - Revised (CDRS-R): Behaviour. The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 items. Each item is graded on a 5- or 7-point scale. behaviour is one of four subscores defined in the CDRS-R:sum of items 1, 2, 3; score ranges from 3 to 21. The highest possible score indicates the most severe measure of depression.
Time Frame
From Randomization to Week 8
Title
CDRS-R Response
Description
Children Depression Rating Scale - Response: defined as a >= 50% decrease in CDRS-R total score, calculated as (change from baseline [Randomization])/(baseline value - 17).
Time Frame
From Randomization to Week 8
Title
CDRS-R Remission
Description
Remission is defined as a CDRS-R total score <= 28.
Time Frame
From Randomization to Week 8
Title
Change in General Behaviour Inventory (GBI) Depression Sub Scale Score Assessed by the Parents
Description
Using the 10-item depression subscale, assessed by parent (PGBI-10D). Change from randomization to Week 8 in GBI Total Parent/Guardian Version Depression score. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.
Time Frame
From randomization to week 8
Title
Change General Behaviour Inventory (GBI) Depression Subscale Score Assessed by the Child
Description
The GBI 10-item mania scale is a parent- and subject-rated scale designed to screen for manic symptoms in children and adolescents. The 10 items are rated on a scale from 0 (never or hardly ever) to 3 (very often or almost constantly). The total score ranges from 0 to 30 points, with high scores indicating greater pathology.
Time Frame
From randomization to Week 8
Title
Parent Global Assessment-Global Improvement (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 change from Baseline symptoms using a 7 point scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
From Randomization to Week 8
Title
Change in Symbol Digit Modalities Test (SDMT)
Description
The Symbol Digit Modalities Test (SDMT) is a cognitive test designed to assess speed of performance requiring visual perception, spatial decision-making and psychomotor skills. The SDMT consists of 110 geometric symbols that the patient has to substitute with a corresponding digit in a 90-second period. Each correct digit is counted, and the total score ranges from 0 (less than normal functioning) to 110 (greater than normal functioning).
Time Frame
From Randomization to Week 8
Title
Change in Clinical Global Impression Severity of Illness (CGI-S) Score
Description
The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
Time Frame
From Randomization to Week 8
Title
Clinical Global Impression - Global Improvement (CGI-I) Score
Description
The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not.
Time Frame
From Randomization to Week 8
Title
CGI-S Remission
Description
Remission defined as CGI-S score of 1 or 2.
Time Frame
From Randomization to Week 8
Title
Change in Children's Global Assessment Scale (CGAS) Score
Description
The Children's Global Assessment Score (CGAS) is a rating scale which measures psychological, social and school functioning for children. 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 items range in value from 1 (most functionally impaired child) to 100 (the healthiest). A total score above 70 indicates normal function.
Time Frame
From Randomization to Week 8
Title
Change in Pediatric Quality of Life Inventory (PedsQL) Visual Analogue Scales (VAS): Afraid or Scared (Anxiety) Score
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 patients are asked to mark on the line how they feel. A lower value represents a better outcome.
Time Frame
From Randomization to Week 8
Title
Change in PedsQL VAS: Sad or Blue (Sadness) Score
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 patients are asked to mark on the line how they feel. A lower value represents a better outcome.
Time Frame
From Randomization to Week 8
Title
Change in PedsQL VAS: Angry Score
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 patients are asked to mark on the line how they feel. A lower value represents a better outcome.
Time Frame
From Randomization to Week 8
Title
Change in PedsQL VAS: Worry Score
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 patients are asked to mark on the line how they feel. A lower value represents a better outcome.
Time Frame
From Randomization to Week 8
Title
Change in PedsQL VAS: Tired (Fatigue) Score
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 patients are asked to mark on the line how they feel. A lower value represents a better outcome.
Time Frame
From Randomization to week 8
Title
Change in PedsQL VAS: Pain or Hurt Score
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 patients are asked to mark on the line how they feel. A lower value represents a better outcome.
Time Frame
From Randomization to Week 8
Title
Change in PedsQL VAS Total Average Score
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 patients 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
From Randomization to week 8
Title
Change in PedsQL Emotional Distress Summary Average Score
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 patients 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
From Randomization to week 8
Title
Change in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Scores
Description
PQ-LES-Q total score (items 1 to 14). 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 (Q-LES-Q), which is used to measure quality of life in adults. The PQ LES Q consist of 15 items, item 1-14 assess the degree of satisfaction experienced by subjects in various areas of daily functioning (and item 15 allows subjects to summarize 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 1-14 (this outcome measurement) is 14 to 70, with higher scores indicating greater satisfaction.
Time Frame
From Randomization to Week 8
Title
Change in PQ-LES-Q Overall Score
Description
PQ-LES-Q overall evaluation score (item 15). 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 (Q-LES-Q), which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1-14 assess the degree of satisfaction experienced by subjects in various areas of daily functioning and item 15 allows subjects to summarize their experience in a global rating (this outcome measurement). Item 15 is rated on a 5-point scale from 1 (very poor) to 5 (very good).
Time Frame
From Randomization to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient is a male or female, aged ≥12 and ≤17 years at Screening (patients who turn 18 years during the study will be allowed to continue in the study). The patient has Major depressive disorder (MDD), diagnosed according to DSM-5™. The patient has a Children Depression Rating Scale - Revised (CDRS-R) total score ≥45 at the Screening Visit and at the Baseline. The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≥4 at the Screening Visit and at the Baseline The patient has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form. Exclusion Criteria: The patient has participated in a clinical study <30 days prior to the Screening Visit. Other protocol defined inclusion and exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
US1369
City
Dothan
State/Province
Alabama
Country
United States
Facility Name
US1333
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
US1310
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
US1062
City
Costa Mesa
State/Province
California
Country
United States
Facility Name
US1387
City
Downey
State/Province
California
Country
United States
Facility Name
US1114
City
Escondido
State/Province
California
Country
United States
Facility Name
US1118
City
Glendale
State/Province
California
Country
United States
Facility Name
US1123
City
Imperial
State/Province
California
Country
United States
Facility Name
US1160 Renew Behavioral Health, Inc.
City
Long Beach
State/Province
California
Country
United States
Facility Name
US1368
City
Orange
State/Province
California
Country
United States
Facility Name
US1370
City
Panorama City
State/Province
California
Country
United States
Facility Name
US1351
City
Wildomar
State/Province
California
Country
United States
Facility Name
US1133
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
US1217
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
US1229
City
Orange City
State/Province
Florida
Country
United States
Facility Name
US1009
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
US1313
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
US1311
City
Naperville
State/Province
Illinois
Country
United States
Facility Name
US1315
City
Naperville
State/Province
Illinois
Country
United States
Facility Name
US1103
City
Oak Brook
State/Province
Illinois
Country
United States
Facility Name
US1386
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
US1261
City
Lake Charles
State/Province
Louisiana
Country
United States
Facility Name
US1015
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
US1385 Ericksen Research And Development
City
Clinton
State/Province
Mississippi
Country
United States
Facility Name
US1064
City
Creve Coeur
State/Province
Missouri
Country
United States
Facility Name
US1314
City
O'Fallon
State/Province
Missouri
Country
United States
Facility Name
US1266
City
Saint Charles
State/Province
Missouri
Country
United States
Facility Name
US1312
City
Berlin
State/Province
New Jersey
Country
United States
Facility Name
US1222
City
Princeton
State/Province
New Jersey
Country
United States
Facility Name
US1317
City
New York
State/Province
New York
Country
United States
Facility Name
US1171
City
Rochester
State/Province
New York
Country
United States
Facility Name
US1190
City
Staten Island
State/Province
New York
Country
United States
Facility Name
US1051
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
US1054
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
US1334
City
Middleburg Heights
State/Province
Ohio
Country
United States
Facility Name
US1323
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
US1329
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
US1328
City
Austin
State/Province
Texas
Country
United States
Facility Name
US1320
City
Plano
State/Province
Texas
Country
United States
Facility Name
US1162
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
US1308
City
Orem
State/Province
Utah
Country
United States
Facility Name
US1309
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
BG1023
City
Targovishte
Country
Bulgaria
Facility Name
BG1025
City
Varna
Country
Bulgaria
Facility Name
CA1036 University of Calgary
City
Calgary
Country
Canada
Facility Name
CA1038
City
Toronto
Country
Canada
Facility Name
CO1003
City
Barranquilla
Country
Colombia
Facility Name
CO1001
City
Bello
Country
Colombia
Facility Name
CO1004
City
Bogotá
Country
Colombia
Facility Name
CO1002
City
Pereira
Country
Colombia
Facility Name
EE1007
City
Tallinn
Country
Estonia
Facility Name
EE1015
City
Viljandi
Country
Estonia
Facility Name
FR1041
City
Douai
Country
France
Facility Name
FR1017
City
Elancourt
Country
France
Facility Name
FR1009
City
Nantes
Country
France
Facility Name
DE1078
City
Freiburg
Country
Germany
Facility Name
DE1034
City
Mainz
Country
Germany
Facility Name
DE1077
City
Mannheim
Country
Germany
Facility Name
DE1081
City
Maulbronn
Country
Germany
Facility Name
DE1076
City
Tübingen
Country
Germany
Facility Name
HU1023
City
Budapest
Country
Hungary
Facility Name
HU1020
City
Gyula
Country
Hungary
Facility Name
IT1075
City
Cagliari
Country
Italy
Facility Name
IT1073
City
Genova
Country
Italy
Facility Name
IT1029
City
Messina
Country
Italy
Facility Name
IT1068
City
Napoli
Country
Italy
Facility Name
IT1074
City
Padova
Country
Italy
Facility Name
IT1070
City
Pisa
Country
Italy
Facility Name
IT1072 Osppedale Bambin gesu
City
Rome
Country
Italy
Facility Name
KR1035
City
Cheonan
Country
Korea, Republic of
Facility Name
UA1037
City
Gyeongsang
Country
Korea, Republic of
Facility Name
KR1032
City
Seoul
Country
Korea, Republic of
Facility Name
KR1038
City
Seoul
Country
Korea, Republic of
Facility Name
LV1002
City
Jelgava
Country
Latvia
Facility Name
LV1008
City
Liepaja
Country
Latvia
Facility Name
LV1009
City
Riga
Country
Latvia
Facility Name
LV1007
City
Sigulda
Country
Latvia
Facility Name
MX1003
City
Ciudad de mexico
Country
Mexico
Facility Name
MX1014
City
Culiacán
Country
Mexico
Facility Name
MX1011
City
Guadalajara
Country
Mexico
Facility Name
MX1013
City
Guadalajara
Country
Mexico
Facility Name
MX1022
City
Guadalajara
Country
Mexico
Facility Name
MX1023
City
Mazatlán
Country
Mexico
Facility Name
MX1001
City
Nuevo León
Country
Mexico
Facility Name
PL1002
City
Bialystok
Country
Poland
Facility Name
PL1050
City
Gdansk
Country
Poland
Facility Name
PL1068
City
Kielce
Country
Poland
Facility Name
PL1057
City
Lublin
Country
Poland
Facility Name
PL1052
City
Poznan
Country
Poland
Facility Name
PL1051
City
Wroclaw
Country
Poland
Facility Name
PL1054
City
Wąbrzeźno
Country
Poland
Facility Name
RU1009
City
Arkhangel'sk
Country
Russian Federation
Facility Name
RU1016
City
Ekaterinburg
Country
Russian Federation
Facility Name
RU1059
City
Engel's
Country
Russian Federation
Facility Name
RU1046
City
Krasnodar
Country
Russian Federation
Facility Name
RU1011
City
Lipetsk
Country
Russian Federation
Facility Name
RU1004
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
RU1010
City
Novosibirsk
Country
Russian Federation
Facility Name
RU1012
City
Rostov on Don
Country
Russian Federation
Facility Name
RU1044
City
Rostov-na-Donu
Country
Russian Federation
Facility Name
RU1013
City
Saratov
Country
Russian Federation
Facility Name
RU1038
City
Saratov
Country
Russian Federation
Facility Name
RU1030
City
St.Petersburg
Country
Russian Federation
Facility Name
RU1057
City
Tomsk
Country
Russian Federation
Facility Name
RU1048
City
Tonnel'nyy
Country
Russian Federation
Facility Name
RS1006 Clinic of Neurology and Psychiatry for Children and Adolescents
City
Belgrade
Country
Serbia
Facility Name
RS1010
City
Belgrad
Country
Serbia
Facility Name
RS1011
City
Kragujevac
Country
Serbia
Facility Name
RS1003
City
Niš
Country
Serbia
Facility Name
RS1007
City
Novi Sad
Country
Serbia
Facility Name
ZA1019
City
Cape Town
Country
South Africa
Facility Name
ZA1022
City
Randburg
Country
South Africa
Facility Name
ZA1023
City
Sandton
Country
South Africa
Facility Name
ES1041
City
Alcorcon
Country
Spain
Facility Name
ES1044
City
Madrid
Country
Spain
Facility Name
ES1043
City
Pamplona
Country
Spain
Facility Name
ES1018 Hospital de Sabadell
City
Sabadell
Country
Spain
Facility Name
ES1040
City
Torremolinos
Country
Spain
Facility Name
UA1002
City
Kyiv
Country
Ukraine
Facility Name
UA1019
City
Odessa
Country
Ukraine
Facility Name
UA1001
City
Poltava
Country
Ukraine
Facility Name
UA1004
City
Ternopil'
Country
Ukraine
Facility Name
GB1051
City
Glasgow
Country
United Kingdom
Facility Name
GB1047
City
Liverpool
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35033635
Citation
Findling RL, DelBello MP, Zuddas A, Emslie GJ, Ettrup A, Petersen ML, Schmidt SN, Rosen M. Vortioxetine for Major Depressive Disorder in Adolescents: 12-Week Randomized, Placebo-Controlled, Fluoxetine-Referenced, Fixed-Dose Study. J Am Acad Child Adolesc Psychiatry. 2022 Sep;61(9):1106-1118.e2. doi: 10.1016/j.jaac.2022.01.004. Epub 2022 Jan 13.
Results Reference
derived

Learn more about this trial

Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)

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