Clinical Trial Results:
Interventional, randomized, double-blind, placebo-controlled study of the efficacy and safety of initial administration of 25 mg vortioxetine intravenously with 10 mg/day vortioxetine orally in patients with Major Depressive Disorder
Summary
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EudraCT number |
2018-000992-34 |
Trial protocol |
LV EE BG |
Global end of trial date |
28 Aug 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
31 Jul 2020
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First version publication date |
31 Jul 2020
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Other versions |
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 |
17915A
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03766867 | ||
WHO universal trial number (UTN) |
- | ||
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 |
Lundbeck Clinical Trials, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@lundbeck.com
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Scientific contact |
Lundbeck Clinical Trials, 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) |
No
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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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Aug 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Jul 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Aug 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The purpose of this study is to evaluate the efficacy and safety of vortioxetine given as a single intravenous dose of 25 mg at initiation of an oral vortioxetine regimen of 10 mg/day for 7 days
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Protection of trial subjects |
The trial was conducted in accordance with the Declaration of Helsinki (2013) and ICH Good Clinical Practice (1996).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Nov 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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: 44
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Country: Number of subjects enrolled |
Estonia: 25
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Country: Number of subjects enrolled |
Latvia: 12
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Worldwide total number of subjects |
81
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EEA total number of subjects |
81
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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) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
79
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||
Pre-assignment
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Screening details |
Subjects who met each of the inclusion and none of the exclusion criteria were eligible to participate in the study. | |||||||||||||||
Period 1
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Period 1 title |
Placebo Lead-in
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Is this the baseline period? |
No | |||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Single blind | |||||||||||||||
Roles blinded |
Subject | |||||||||||||||
Arms
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Arm title
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Placebo | |||||||||||||||
Arm description |
one day single-blind treatment with placebo | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
film-coated tablet, oral administration. one day single-blind treatment with placebo
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Investigational medicinal product name |
Placebo infusion
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
concentrate for solution for infusion, 25 mL administered in 250 mL saline over 2 hours as single dose
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Period 2
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Period 2 title |
Double-blind Period (DBT)
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Is this the baseline period? |
Yes [1] | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Vortioxetine | |||||||||||||||
Arm description |
Double-blind Treatment (DBT) Period with vortioxetine | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Vortioxetine infusion 25 mg
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Investigational medicinal product code |
Lu AA21004
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Vortioxetine – 25mg, IV infusion of 25mL 1mg/mL concentrate for solution for infusion on Day 0
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Investigational medicinal product name |
Vortioxetine tablets 10 mg/day
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Investigational medicinal product code |
Lu AA21004
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Other name |
Brintellix ®
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
10 mg, tablets, oral administration once daily. 7 tablets for a duration of 7 days
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Arm title
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Placebo | |||||||||||||||
Arm description |
Double-blind Treatment (DBT) Period with placebo | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Placebo tablets
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
film-coated tablets, oral administration once daily. 7 tablets for a duration of 7 days
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Investigational medicinal product name |
Placebo infusion
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
concentrate for solution for infusion, 25 mL administered in 250 mL saline over 2 hours as single dose
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Notes [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period. Justification: Period 1 is the lead-in period of the study |
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Notes [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: It is correct that not all the patients that enrolled the study started the double bind treatment period which explains that the numbers are not the same. [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: It is correct that the number of subjects starting the DBT period is not consistent with the number completing the preceding lead-in period: not all the patients that enrolled the study started the double bind treatment period which explains that the numbers are not the same. |
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Baseline characteristics reporting groups
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Reporting group title |
Vortioxetine
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Reporting group description |
Double-blind Treatment (DBT) Period with vortioxetine | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Double-blind Treatment (DBT) Period with placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
one day single-blind treatment with placebo | ||
Reporting group title |
Vortioxetine
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Reporting group description |
Double-blind Treatment (DBT) Period with vortioxetine | ||
Reporting group title |
Placebo
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Reporting group description |
Double-blind Treatment (DBT) Period with placebo |
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End point title |
Change from Baseline (Day 0) to Day 1 (24hours post-infusion) in Montgomery and Åsberg Depression Rating Scale (MADRS)-6 subscale score | ||||||||||||
End point description |
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. This endpoint will be evaluated with MADRS-6 subscale score, calculated based on the scores on MADRS items 1, 2, 3, 7, 8, and 9 which cover core symptoms (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts) and is more sensitive to the effect of treatment.
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End point type |
Primary
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End point timeframe |
From baseline (Day 0) to Day 1 (24 h post-infusion)
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Statistical analysis title |
Ratio vortioxetine vs placebo | ||||||||||||
Statistical analysis description |
The primary efficacy analysis was a mixed model for repeated measures (MMRM) of the change from Baseline to Day 1 in MADRS-6 subscore scale. The model included the following fixed effects: site, Day (1,3, and 7), and treatment; the Baseline MADRS-6 subscale score as a continuous covariate; and the treatmentby-Day interaction; and the Baseline score-by-day interaction. The analysis was based on the missed at random (MAR) assumption including all available observations (observed cases [OC] )
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Comparison groups |
Vortioxetine v Placebo
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Number of subjects included in analysis |
80
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.2675 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (net) | ||||||||||||
Point estimate |
-0.97
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-2.19 | ||||||||||||
upper limit |
0.61 |
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End point title |
Change from Baseline (Day 0) to Day 3 in MADRS-6 subscale | ||||||||||||
End point description |
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. This endpoint will be evaluated with MADRS-6 subscale score, calculated based on the scores on MADRS items 1, 2, 3, 7, 8, and 9 which cover core symptoms (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts) and is more sensitive to the effect of treatment.
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End point type |
Secondary
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End point timeframe |
From baseline (Day 0) to Day 3
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Statistical analysis title |
Ratio vortioxetine vs placebo (Day 3) | ||||||||||||
Statistical analysis description |
The key secondary efficacy analysis of the continuous variables (change from Baseline in MADRS-6 subscale score), was performed using the same methodology (FAS, MMRM) as for the primary efficacy variable.
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Comparison groups |
Placebo v Vortioxetine
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Number of subjects included in analysis |
80
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
Method |
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Parameter type |
Mean difference (net) | ||||||||||||
Point estimate |
-0.06
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-2.08 | ||||||||||||
upper limit |
1.97 |
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End point title |
Change from Baseline (Day 0) to Day 7 in MADRS-6 subscale score | ||||||||||||
End point description |
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. This endpoint will be evaluated with MADRS-6 subscale score, calculated based on the scores on MADRS items 1, 2, 3, 7, 8, and 9 which cover core symptoms (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts) and is more sensitive to the effect of treatment.
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End point type |
Secondary
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End point timeframe |
From baseline to day 7
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No statistical analyses for this end point |
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End point title |
Change from Baseline in MADRS total score at Day 1 | ||||||||||||
End point description |
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. This endpoint will be evaluated with MADRS total score.
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End point type |
Secondary
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End point timeframe |
From Baseline to Day 1
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No statistical analyses for this end point |
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End point title |
Change from Baseline in MADRS total score at Day 3 | ||||||||||||
End point description |
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. This endpoint will be evaluated with MADRS total score.
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End point type |
Secondary
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End point timeframe |
From Baseline to Day 3
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No statistical analyses for this end point |
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End point title |
Change from Baseline in MADRS total score at Day 7 | ||||||||||||
End point description |
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. This endpoint will be evaluated with MADRS total score.
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End point type |
Secondary
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End point timeframe |
Change from Baseline in MADRS total score at Day 7
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No statistical analyses for this end point |
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End point title |
Response (defined as a >= 50% decrease in MADRS total score from Baseline) on Day 1 | |||||||||
End point description |
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. This endpoint will be evaluated with MADRS total score.
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End point type |
Secondary
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End point timeframe |
From baseline to Day 1
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No statistical analyses for this end point |
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End point title |
Response (defined as a >= 50% decrease in MADRS total score from Baseline) on Day 3 | |||||||||
End point description |
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. This endpoint will be evaluated with MADRS total score.
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End point type |
Secondary
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End point timeframe |
From baseline to Day 3
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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 relative to Baseline at Day 1 | ||||||||||||
End point description |
The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). 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.
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End point type |
Secondary
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End point timeframe |
From baseline to Day 1
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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 relative to Baseline at Day 3 | ||||||||||||
End point description |
The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). 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.
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End point type |
Secondary
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End point timeframe |
From baseline to Day 3
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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 relative to Baseline at Day 7 | ||||||||||||
End point description |
The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). 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.
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End point type |
Secondary
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End point timeframe |
From baseline to Day 7
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No statistical analyses for this end point |
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End point title |
CGI-I response (defined as CGI-I score <= 2) on Day 1 | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From baseline to Day 1
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No statistical analyses for this end point |
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End point title |
CGI-I response (defined as CGI-I score <= 2) on Day 3 | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From baseline to Day 3
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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 Day 1 | ||||||||||||
End point description |
The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). 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).
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End point type |
Secondary
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End point timeframe |
From baseline to Day 1
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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 Day 3 | ||||||||||||
End point description |
The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). 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).
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End point type |
Secondary
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End point timeframe |
From baseline to Day 3
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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 Day 7 | ||||||||||||
End point description |
The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). 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).
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End point type |
Secondary
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End point timeframe |
From baseline to Day 7
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No statistical analyses for this end point |
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End point title |
Cav Day 0 (2hrs post-IV) [1] | ||||||||
End point description |
Average plasma concentration during a steady-state day
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End point type |
Secondary
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End point timeframe |
Day 0
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Notes [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: No data available |
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No statistical analyses for this end point |
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End point title |
Cav Day 0 (bed time) [2] | ||||||||
End point description |
average plasma concentration during a steady-state day
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End point type |
Secondary
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End point timeframe |
Day 0
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Notes [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: No data available |
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No statistical analyses for this end point |
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End point title |
Cav Day 1 [3] | ||||||||
End point description |
average plasma concentration during a steady-state day
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End point type |
Secondary
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End point timeframe |
Day 1
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Notes [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: No data available |
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No statistical analyses for this end point |
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End point title |
Cav Day 7 [4] | ||||||||
End point description |
average plasma concentration during a steady-state day
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End point type |
Secondary
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End point timeframe |
Day 7
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Notes [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: No data available |
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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 |
35 days
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21.0
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Reporting groups
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Reporting group title |
DBT: Vortioxetine IV 25 mg + Vortioxetine Oral 10 mg
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
DBT: Placebo IV + Placebo Oral
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? No | |||
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. | |||
None reported |