Trial Outcomes & Findings for Vortioxetine for Post-COVID-19 Condition (NCT NCT05047952)
NCT ID: NCT05047952
Last Updated: 2025-01-16
Results Overview
This measures the least square mean change in baseline-to-end point on z-score on the combined DSST. Depicted is the least square (LS) mean \[standard error of mean (SEM)\] change in DSST z-scores from baseline to week 8 using an independent covariance matrix with time as a categorical variable, adjusted for the type of cognitive test (Pen/Paper versus Online CogState version). Larger least squares mean indicates a higher predicted or adjusted average outcome for that group or condition compared to others. In other words, if you have a higher least squares mean for a treatment group, it suggests that, after adjusting for the effects of other variables, that group tends to have a higher average outcome, indicating better performance. A least squares mean of 0 indicates that the groups has no difference in average outcome. There is no fixed maximum or minimum for LS Means. They are derived from the data and can, in principle, take any real value (positive, negative, or zero)
COMPLETED
PHASE2
149 participants
Weeks 0-8
2025-01-16
Participant Flow
Participant milestones
| Measure |
Vortioxetine
Participants aged 18-64 years: start at 10 mg vortioxetine once daily for the first 2 weeks, then dosed up to 20 mg vortioxetine once daily for weeks 2-8.
Participants aged 65+ years: start at 5 mg vortioxetine once daily for the first 2 weeks, then dosed up to 10 mg vortioxetine once daily for weeks 2-8.
Vortioxetine: Participants aged 18-64 years receiving vortioxetine will be provided 10 mg/day on days 1-14 of the treatment period, and will be titrated to 20 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 20 mg/day, unless adjudicated otherwise by a study clinician.
Per product monograph, participants aged 65+ years receiving vortioxetine will be provided 5 mg/day on days 1-14 of the treatment period, and will be titrated to 10 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 10 mg/day, unless adjudicated otherwise by a study clinician.
|
Placebo
Placebo capsule taken once daily for weeks 0-8.
Placebo: A placebo pill will be taken once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
74
|
|
Overall Study
COMPLETED
|
68
|
73
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vortioxetine for Post-COVID-19 Condition
Baseline characteristics by cohort
| Measure |
Vortioxetine
n=75 Participants
Participants aged 18-64 years: start at 10 mg vortioxetine once daily for the first 2 weeks, then dosed up to 20 mg vortioxetine once daily for weeks 2-8.
Participants aged 65+ years: start at 5 mg vortioxetine once daily for the first 2 weeks, then dosed up to 10 mg vortioxetine once daily for weeks 2-8.
Vortioxetine: Participants aged 18-64 years receiving vortioxetine will be provided 10 mg/day on days 1-14 of the treatment period, and will be titrated to 20 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 20 mg/day, unless adjudicated otherwise by a study clinician.
Per product monograph, participants aged 65+ years receiving vortioxetine will be provided 5 mg/day on days 1-14 of the treatment period, and will be titrated to 10 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 10 mg/day, unless adjudicated otherwise by a study clinician.
|
Placebo
n=74 Participants
Placebo capsule taken once daily for weeks 0-8.
Placebo: A placebo pill will be taken once daily.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.65 years
STANDARD_DEVIATION 12.26 • n=5 Participants
|
44.94 years
STANDARD_DEVIATION 12.03 • n=7 Participants
|
44.36 years
STANDARD_DEVIATION 12.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
58 participants
n=5 Participants
|
55 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Caucasian
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
75 participants
n=5 Participants
|
74 participants
n=7 Participants
|
149 participants
n=5 Participants
|
|
Confirmed COVID Diagnosis
|
59 participants
n=5 Participants
|
59 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
Lifetime Major Depressive Disorder Diagnosis
|
32 participants
n=5 Participants
|
25 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Highest Education = Highschool
|
18 participants
n=5 Participants
|
14 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Highest Education = College/University
|
47 participants
n=5 Participants
|
42 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Highest Education - Graduate School
|
10 participants
n=5 Participants
|
18 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Combined Digit Symbol Substitution Test
|
-0.02 units on a scale
STANDARD_DEVIATION 0.91 • n=5 Participants
|
-0.21 units on a scale
STANDARD_DEVIATION 0.96 • n=7 Participants
|
-0.07127 units on a scale
STANDARD_DEVIATION 1.002 • n=5 Participants
|
|
Computurized Digit Symbol Substitution Test (DSST)
|
48.40 Total Number of Symbols
STANDARD_DEVIATION 10.11 • n=5 Participants
|
46.35 Total Number of Symbols
STANDARD_DEVIATION 10.75 • n=7 Participants
|
47.36 Total Number of Symbols
STANDARD_DEVIATION 10.50 • n=5 Participants
|
|
Remote Participation in Trial, n (%)
|
38 participants
n=5 Participants
|
40 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
The Quick Inventory of Depressive Symptomatology-Self-report (QIDS-SR16)
|
10.03 Total Score
STANDARD_DEVIATION 4.33 • n=5 Participants
|
10.32 Total Score
STANDARD_DEVIATION 4.37 • n=7 Participants
|
10.18 Total Score
STANDARD_DEVIATION 4.33 • n=5 Participants
|
|
The 5-item World Health Organization Well-Being Index (WHO-5)
|
9.808 Total Score
STANDARD_DEVIATION 4.579 • n=5 Participants
|
9.757 Total Score
STANDARD_DEVIATION 9.808 • n=7 Participants
|
9.808 Total Score
STANDARD_DEVIATION 4.245 • n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 0-8This measures the least square mean change in baseline-to-end point on z-score on the combined DSST. Depicted is the least square (LS) mean \[standard error of mean (SEM)\] change in DSST z-scores from baseline to week 8 using an independent covariance matrix with time as a categorical variable, adjusted for the type of cognitive test (Pen/Paper versus Online CogState version). Larger least squares mean indicates a higher predicted or adjusted average outcome for that group or condition compared to others. In other words, if you have a higher least squares mean for a treatment group, it suggests that, after adjusting for the effects of other variables, that group tends to have a higher average outcome, indicating better performance. A least squares mean of 0 indicates that the groups has no difference in average outcome. There is no fixed maximum or minimum for LS Means. They are derived from the data and can, in principle, take any real value (positive, negative, or zero)
Outcome measures
| Measure |
Placebo
n=74 Participants
Placebo capsule taken once daily for weeks 0-8.
Placebo: A placebo pill will be taken once daily.
|
Vortioxetine
n=75 Participants
Participants aged 18-64 years: start at 10 mg vortioxetine once daily for the first 2 weeks, then dosed up to 20 mg vortioxetine once daily for weeks 2-8.
Participants aged 65+ years: start at 5 mg vortioxetine once daily for the first 2 weeks, then dosed up to 10 mg vortioxetine once daily for weeks 2-8.
Vortioxetine: Participants aged 18-64 years receiving vortioxetine will be provided 10 mg/day on days 1-14 of the treatment period, and will be titrated to 20 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 20 mg/day, unless adjudicated otherwise by a study clinician.
Per product monograph, participants aged 65+ years receiving vortioxetine will be provided 5 mg/day on days 1-14 of the treatment period, and will be titrated to 10 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 10 mg/day, unless adjudicated otherwise by a study clinician.
|
|---|---|---|
|
Least Square Mean Change in Baseline to Week 8 on Z-score in Combined Digit Symbol Substitution Test (DSST)
|
0.184 score on a scale
Standard Error 0.0934
|
0.332 score on a scale
Standard Error 0.0752
|
SECONDARY outcome
Timeframe: Weeks 0-8This measures the least square mean change in baseline-to-end point on scores on the WHO-5. Depicted is the least square (LS) mean \[standard error of mean (SEM)\] change in WHO-5 from baseline to week 8. Larger least squares mean indicates a higher predicted or adjusted average outcome for that group or condition compared to others. In other words, if you have a higher least squares mean for a treatment group, it suggests that, after adjusting for the effects of other variables, that group tends to have a higher average outcome, indicating better performance. A least squares mean of 0 indicates that the groups has no difference in average outcome. There is no fixed maximum or minimum for LS Means. They are derived from the data and can, in principle, take any real value (positive, negative, or zero)
Outcome measures
| Measure |
Placebo
n=73 Participants
Placebo capsule taken once daily for weeks 0-8.
Placebo: A placebo pill will be taken once daily.
|
Vortioxetine
n=67 Participants
Participants aged 18-64 years: start at 10 mg vortioxetine once daily for the first 2 weeks, then dosed up to 20 mg vortioxetine once daily for weeks 2-8.
Participants aged 65+ years: start at 5 mg vortioxetine once daily for the first 2 weeks, then dosed up to 10 mg vortioxetine once daily for weeks 2-8.
Vortioxetine: Participants aged 18-64 years receiving vortioxetine will be provided 10 mg/day on days 1-14 of the treatment period, and will be titrated to 20 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 20 mg/day, unless adjudicated otherwise by a study clinician.
Per product monograph, participants aged 65+ years receiving vortioxetine will be provided 5 mg/day on days 1-14 of the treatment period, and will be titrated to 10 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 10 mg/day, unless adjudicated otherwise by a study clinician.
|
|---|---|---|
|
Baseline to Endpoint Change in World Health Organization Wellbeing Scale, 5-item (WHO-5)
|
1.107 score on a scale
Standard Error 0.590
|
1.759 score on a scale
Standard Error 0.489
|
SECONDARY outcome
Timeframe: Week 0-8This measures the least square mean change in baseline-to-end point on the QIDS-SR-16. A negative least squares estimate for the QIDS-SR-16 score from baseline to week 8 indicates a reduction in depressive symptoms. Specifically, it implies that, on average, the QIDS-SR-16 scores have decreased over the 8-week period. Since lower QIDS-SR-16 scores correspond to less severe depressive symptoms, a negative change is a positive outcome, showing improvement. A least squares mean of 0 indicates that the groups has no difference in average outcome. There is no fixed maximum or minimum for LS Means. They are derived from the data and can, in principle, take any real value (positive, negative, or zero)
Outcome measures
| Measure |
Placebo
n=73 Participants
Placebo capsule taken once daily for weeks 0-8.
Placebo: A placebo pill will be taken once daily.
|
Vortioxetine
n=67 Participants
Participants aged 18-64 years: start at 10 mg vortioxetine once daily for the first 2 weeks, then dosed up to 20 mg vortioxetine once daily for weeks 2-8.
Participants aged 65+ years: start at 5 mg vortioxetine once daily for the first 2 weeks, then dosed up to 10 mg vortioxetine once daily for weeks 2-8.
Vortioxetine: Participants aged 18-64 years receiving vortioxetine will be provided 10 mg/day on days 1-14 of the treatment period, and will be titrated to 20 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 20 mg/day, unless adjudicated otherwise by a study clinician.
Per product monograph, participants aged 65+ years receiving vortioxetine will be provided 5 mg/day on days 1-14 of the treatment period, and will be titrated to 10 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 10 mg/day, unless adjudicated otherwise by a study clinician.
|
|---|---|---|
|
Baseline-to-endpoint (i.e., Week 8) Change in the Quick Inventory of Depressive Symptomology, Self Report (QIDS-SR-16)
|
-1.756 units on a scale
Standard Error 0.503
|
-3.351 units on a scale
Standard Error 0.524
|
Adverse Events
Vortioxetine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vortioxetine
n=75 participants at risk
Participants aged 18-64 years: start at 10 mg vortioxetine once daily for the first 2 weeks, then dosed up to 20 mg vortioxetine once daily for weeks 2-8.
Participants aged 65+ years: start at 5 mg vortioxetine once daily for the first 2 weeks, then dosed up to 10 mg vortioxetine once daily for weeks 2-8.
Vortioxetine: Participants aged 18-64 years receiving vortioxetine will be provided 10 mg/day on days 1-14 of the treatment period, and will be titrated to 20 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 20 mg/day, unless adjudicated otherwise by a study clinician.
Per product monograph, participants aged 65+ years receiving vortioxetine will be provided 5 mg/day on days 1-14 of the treatment period, and will be titrated to 10 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 10 mg/day, unless adjudicated otherwise by a study clinician.
|
Placebo
n=74 participants at risk
Placebo capsule taken once daily for weeks 0-8.
Placebo: A placebo pill will be taken once daily.
|
|---|---|---|
|
Nervous system disorders
Fatigue
|
10.7%
8/75 • Number of events 8 • Adverse events will be collected from baseline (Week 1) to endpoint (Week 8).
|
10.8%
8/74 • Number of events 8 • Adverse events will be collected from baseline (Week 1) to endpoint (Week 8).
|
|
Gastrointestinal disorders
Nausea
|
48.0%
36/75 • Number of events 36 • Adverse events will be collected from baseline (Week 1) to endpoint (Week 8).
|
25.7%
19/74 • Number of events 19 • Adverse events will be collected from baseline (Week 1) to endpoint (Week 8).
|
|
Nervous system disorders
Headache
|
8.0%
6/75 • Number of events 6 • Adverse events will be collected from baseline (Week 1) to endpoint (Week 8).
|
9.5%
7/74 • Number of events 7 • Adverse events will be collected from baseline (Week 1) to endpoint (Week 8).
|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
2/75 • Number of events 2 • Adverse events will be collected from baseline (Week 1) to endpoint (Week 8).
|
14.9%
11/74 • Number of events 11 • Adverse events will be collected from baseline (Week 1) to endpoint (Week 8).
|
|
Gastrointestinal disorders
Constipation
|
9.3%
7/75 • Number of events 7 • Adverse events will be collected from baseline (Week 1) to endpoint (Week 8).
|
2.7%
2/74 • Number of events 2 • Adverse events will be collected from baseline (Week 1) to endpoint (Week 8).
|
|
Cardiac disorders
Dyspepsia
|
8.0%
6/75 • Number of events 6 • Adverse events will be collected from baseline (Week 1) to endpoint (Week 8).
|
10.8%
8/74 • Number of events 8 • Adverse events will be collected from baseline (Week 1) to endpoint (Week 8).
|
Additional Information
Dr. Roger S. McIntyre
Brain and Cognition Discovery Foundation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place