Trial Outcomes & Findings for Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age (NCT NCT02871297)
NCT ID: NCT02871297
Last Updated: 2022-12-28
Results Overview
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'.
TERMINATED
PHASE3
662 participants
Baseline up to Week 30
2022-12-28
Participant Flow
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).
Participant milestones
| Measure |
Vortioxetine
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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|---|---|
|
Overall Study
STARTED
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662
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
662
|
|
Overall Study
COMPLETED
|
526
|
|
Overall Study
NOT COMPLETED
|
136
|
Reasons for withdrawal
| Measure |
Vortioxetine
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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|---|---|
|
Overall Study
Adverse Event
|
34
|
|
Overall Study
Lack of Efficacy
|
10
|
|
Overall Study
Non-compliance with study drug
|
15
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Withdrawal by Subject
|
20
|
|
Overall Study
Lost to Follow-up
|
13
|
|
Overall Study
Rolled over to 13546A
|
2
|
|
Overall Study
Other than specified
|
39
|
Baseline Characteristics
Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age
Baseline characteristics by cohort
| Measure |
Vortioxetine
n=662 Participants
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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|---|---|
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Age, Continuous
|
12.33 years
STANDARD_DEVIATION 3.07 • n=5 Participants
|
|
Age, Customized
Children (7-11 years)
|
300 Participants
n=5 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
352 Participants
n=5 Participants
|
|
Age, Customized
Adults (18-64 years)
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
361 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
301 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
447 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
188 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 30Population: APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
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'.
Outcome measures
| Measure |
Vortioxetine
n=662 Participants
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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|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
404 Participants
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SECONDARY outcome
Timeframe: Baseline, Week 26Population: 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 outcome measure.
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 a restricted maximum likelihood-based mixed model for repeated measurements (MMRM) approach.
Outcome measures
| Measure |
Vortioxetine
n=506 Participants
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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|---|---|
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Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 26
|
-16.05 units on a scale
Standard Error 0.63 • Interval 0.63 to
|
SECONDARY outcome
Timeframe: Baseline up to Week 26Population: Due to change in planned analysis, this endpoint was not analyzed; hence, data were not collected for this outcome measure.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 26Population: Due to change in planned analysis, this endpoint was not analyzed; hence, data were not collected for this outcome measure.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 26Population: 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 outcome measure.
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 a restricted maximum likelihood-based MMRM approach.
Outcome measures
| Measure |
Vortioxetine
n=506 Participants
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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|---|---|
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Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26
|
-1.48 units on a scale
Standard Error 0.06 • Interval 0.06 to
|
SECONDARY outcome
Timeframe: Week 26Population: 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 outcome measure.
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 a restricted maximum likelihood-based MMRM approach.
Outcome measures
| Measure |
Vortioxetine
n=506 Participants
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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|---|---|
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Clinical Global Impression - Global Improvement (CGI-I) Score
|
1.72 units on a scale
Standard Error 0.04 • Interval 0.04 to
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: 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 outcome measure.
BRIEF form is an 86-item measure with symptoms rated on a 3-point likert scale of 1 "never", 2 "sometimes" or 3 "often". These items cover 8 non-overlapping clinical scales. For BRIEF-P form, only the first 72 items (Inhibit \[10\], Shift \[8\], Emotional Control \[10\], Initiate \[8\], Working Memory \[10\], Plan/Organize \[12\], Organization of Materials \[6\], Monitor \[8\]) were included in clinical scales. Clinical scales combined to form 2 indexes, Behavioural Regulation Index (BRI) and Metacognition Index (MI), and 1 composite summary score, the GEC, that incorporates all 8 clinical scales. GEC score was calculated as the sum of index scores ranging from 72-216; higher scores indicating greater impairment in executive functions. Raw scores converted to T-scores as detailed in T-score conversion tables for BRIEF-P. Conversion was based on gender and age group. T-scores ranged between 30 to 101, with a lower score indicating better functioning.
Outcome measures
| Measure |
Vortioxetine
n=217 Participants
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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|---|---|
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Children (7-11 Years): Change From Baseline in Behaviour Rating Inventory of Executive Function - Preschool (BRIEF-P) Using the Global Executive Composite (GEC) Score at Week 26
|
-7.41 T score
Standard Deviation 11.70 • Interval 11.7 to
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: 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 outcome measure.
BRIEF form 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". These items cover 8 non-overlapping clinical scales. For BRIEF-SR form, only 80 items (Inhibit \[13\], Shift \[10\], Emotional Control \[10\], Initiate \[5\], Working Memory \[12\], Plan/Organize \[13\], Organization of Materials \[7\], Monitor \[10\]) were included in clinical scales. Clinical scales combined to form 2 indexes, the BRI and the MI, and 1 composite summary score, the GEC, that incorporates all 8 clinical scales. GEC score was calculated as the sum of index scores and ranges from 80-240 with higher scores indicating greater impairment in functions. Raw scores converted to T-scores as detailed in T-score conversion tables for BRIEF-SR. The conversion was based on gender and the age group. T-scores ranged between 29 to 104, with a lower score indicating better functioning.
Outcome measures
| Measure |
Vortioxetine
n=272 Participants
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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|---|---|
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Adolescents (12-18 Years): Change From Baseline in Behaviour Rating Inventory of Executive Function - Self-report (BRIEF-SR) Using the GEC Score at Week 26
|
-7.50 T score
Standard Deviation 13.82 • Interval 13.82 to
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: 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 outcome measure.
BRIEF form 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". These items cover 8 non-overlapping clinical scales. Clinical scales combined to form 2 indexes, the BRI and the MI. For BRIEF-P, MI is comprised of Initiate (8), Working Memory (10), Plan/Organize (12), Organization of Materials (6), and Monitor (8) scales. The MI scores are calculated as the sum of the total 44 items ranging from 44 to 132 with lower scores reflecting better functioning. Raw scores converted to T-scores as detailed in T-score conversion tables for BRIEF-P. The conversion was based on gender and the age group. T-scores ranged between 30 to 98, with a lower score indicating better functioning.
Outcome measures
| Measure |
Vortioxetine
n=217 Participants
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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|---|---|
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Children (7-11 Years): Change From Baseline in BRIEF-P Using the MI Score at Week 26
|
-7.36 T score
Standard Deviation 11.98 • Interval 11.98 to
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: 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 outcome measure.
BRIEF form 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". These items cover 8 non-overlapping clinical scales. Clinical scales combined to form 2 indexes, the BRI and the MI. For BRIEF-SR, MI is comprised of Working Memory (12), Plan/Organize (13), Organization of Materials (7), and Task Completion (10) scales. The MI scores are calculated as the sum of the total 42 items ranging from 42 to 126 with lower scores reflecting better functioning. Raw scores converted to T-scores as detailed in T-score conversion tables for BRIEF-SR. The conversion was based on gender and the age group. T-scores ranged between 31 to 100, with a lower score indicating better functioning.
Outcome measures
| Measure |
Vortioxetine
n=272 Participants
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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|---|---|
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Adolescents (12-18 Years): Change From Baseline in BRIEF-SR Using the MI Score at Week 26
|
-7.18 T score
Standard Deviation 13.71 • Interval 13.71 to
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: 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 outcome measure.
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.
Outcome measures
| Measure |
Vortioxetine
n=506 Participants
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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|---|---|
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Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Week 26
|
14.78 units on a scale
Standard Deviation 14.29 • Interval 14.29 to
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SECONDARY outcome
Timeframe: Baseline, Week 26Population: 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 outcome measure.
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 ranging from 0 to 10, where a lower value represents a better outcome.
Outcome measures
| Measure |
Vortioxetine
n=505 Participants
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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|---|---|
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Change From Baseline in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scale (PedsQL VAS) Total Score at Week 26
|
-1.50 units on a scale
Standard Deviation 1.87 • Interval 1.87 to
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SECONDARY outcome
Timeframe: assessed at Baseline up to Week 26, Week 26 reportedPopulation: 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 outcome measure.
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).
Outcome measures
| Measure |
Vortioxetine
n=153 Participants
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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|---|---|
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Number of Participants With Response to the Palatability Questionnaire
Mouthfeel · Really bad
|
11 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Mouthfeel · Bad
|
17 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Mouthfeel · Neither good or bad
|
38 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Mouthfeel · Good
|
55 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Mouthfeel · Very good
|
32 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Aftertaste · Really bad
|
13 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Aftertaste · Bad
|
26 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Aftertaste · Neither good or bad
|
54 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Aftertaste · Good
|
32 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Aftertaste · Very good
|
28 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Smell · Really bad
|
4 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Smell · Bad
|
4 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Smell · Neither good or bad
|
37 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Smell · Good
|
59 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Smell · Very good
|
49 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Taste · Really bad
|
13 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Taste · Bad
|
15 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Taste · Neither good or bad
|
33 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Taste · Good
|
60 Participants
|
|
Number of Participants With Response to the Palatability Questionnaire
Taste · Very good
|
32 Participants
|
SECONDARY outcome
Timeframe: assessed at Baseline up to Week 26, Week 26 reportedPopulation: 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 outcome measure.
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.
Outcome measures
| Measure |
Vortioxetine
n=153 Participants
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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|---|---|
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Number of Participants With Response to the Acceptability Questionnaire
Willingness to take the drops every day: No
|
27 participants
|
|
Number of Participants With Response to the Acceptability Questionnaire
Willingness to take the drops every day: Not sure
|
17 participants
|
|
Number of Participants With Response to the Acceptability Questionnaire
Willingness to take the drops every day: Yes
|
109 participants
|
|
Number of Participants With Response to the Acceptability Questionnaire
Easy to take medicine: No
|
8 participants
|
|
Number of Participants With Response to the Acceptability Questionnaire
Easy to take medicine: Neither easy or difficult
|
10 participants
|
|
Number of Participants With Response to the Acceptability Questionnaire
Easy to take medicine: Yes
|
135 participants
|
|
Number of Participants With Response to the Acceptability Questionnaire
Acceptability of the taste: No
|
31 participants
|
|
Number of Participants With Response to the Acceptability Questionnaire
Acceptability of the taste: Not sure
|
24 participants
|
|
Number of Participants With Response to the Acceptability Questionnaire
Acceptability of the taste: Yes
|
98 participants
|
Adverse Events
Vortioxetine
Serious adverse events
| Measure |
Vortioxetine
n=662 participants at risk
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.
|
|---|---|
|
Psychiatric disorders
Mania
|
0.15%
1/662 • Number of events 2 • Baseline up to Week 30
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
|
|
Psychiatric disorders
Psychogenic seizure
|
0.15%
1/662 • Number of events 1 • Baseline up to Week 30
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.15%
1/662 • Number of events 1 • Baseline up to Week 30
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
|
|
Psychiatric disorders
Suicidal ideation
|
0.60%
4/662 • Number of events 5 • Baseline up to Week 30
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
|
|
Psychiatric disorders
Suicide attempt
|
0.60%
4/662 • Number of events 5 • Baseline up to Week 30
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.45%
3/662 • Number of events 4 • Baseline up to Week 30
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.15%
1/662 • Number of events 2 • Baseline up to Week 30
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.15%
1/662 • Number of events 1 • Baseline up to Week 30
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.15%
1/662 • Number of events 1 • Baseline up to Week 30
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.15%
1/662 • Number of events 1 • Baseline up to Week 30
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
|
|
Psychiatric disorders
Major depression
|
0.15%
1/662 • Number of events 4 • Baseline up to Week 30
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
|
Other adverse events
| Measure |
Vortioxetine
n=662 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
46/662 • Number of events 58 • Baseline up to Week 30
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
|
|
Gastrointestinal disorders
Nausea
|
20.8%
138/662 • Number of events 212 • Baseline up to Week 30
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
|
|
Gastrointestinal disorders
Vomiting
|
10.4%
69/662 • Number of events 100 • Baseline up to Week 30
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
46/662 • Number of events 61 • Baseline up to Week 30
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
|
|
Nervous system disorders
Dizziness
|
5.7%
38/662 • Number of events 55 • Baseline up to Week 30
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
|
|
Nervous system disorders
Headache
|
17.5%
116/662 • Number of events 198 • Baseline up to Week 30
APTS included all participants who took at least 1 dose of vortioxetine in this study 12712A.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place