Trial Outcomes & Findings for THINC-it Vortioxetine - Sensitivity to Change (NCT NCT03053362)
NCT ID: NCT03053362
Last Updated: 2025-06-08
Results Overview
Change in cognition as measured by the objective assessments of cognition within the THINC-it tool. "THINC-it" is the name of the cognition tool and is not an acronym. The objective measurements that comprise the THINC-it tool include the Spotter task (Choice Reaction Time), Symbol Check task(1-back test),Trails task(Trails Making Test B), and Codebreaker task (Digit Symbol Substitution Test). The composite score from all four tests were converted to standard z-score. Higher z-scores indicate better cognition. A z-score of zero indicates population mean.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
158 participants
Primary outcome timeframe
Baseline and 8 weeks
Results posted on
2025-06-08
Participant Flow
Healthy volunteers were recruited on an ongoing basis until 50 completed volunteers were enrolled. Eight participants began the study but did not complete the study.
Participant milestones
| Measure |
Major Depressive Disorder Population
100 Individuals with DSM-5-defined MDD, aged 18-65
All participants receiving vortioxetine for a total of 8 weeks. Participants will receive10 mg/day on days 1-14 of the study treatment period, with the option to increase to vortioxetine 20 mg/day at the end of Week 2 based on physician's judgment. For the remaining 6 weeks, the dose of vortioxetine will be flexible at 10 or 20 mg/day as decided by a research doctor.
Patients will receive the THINC-it over 3 time frame periods. The THINC-it comprised of: Spotter, Symbol Check, Codebreaker, Trails, and PDQ-5-D.
Vortioxetine: Observing change in cognition using THINC-it tool in patients with MDD.
THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:
Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)
|
Healthy Control Population
50 Healthy Controls (18-65 years of age) matched on sex, age, and years of education
THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:
Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
58
|
|
Overall Study
COMPLETED
|
83
|
50
|
|
Overall Study
NOT COMPLETED
|
17
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
THINC-it Vortioxetine - Sensitivity to Change
Baseline characteristics by cohort
| Measure |
Major Depressive Disorder Population
n=100 Participants
100 Individuals with DSM-5-defined MDD, aged 18-65
All participants receiving vortioxetine for a total of 8 weeks. Participants will receive10 mg/day on days 1-14 of the study treatment period, with the option to increase to vortioxetine 20 mg/day at the end of Week 2 based on physician's judgment. For the remaining 6 weeks, the dose of vortioxetine will be flexible at 10 or 20 mg/day as decided by a research doctor.
Patients will receive the THINC-it over 3 time frame periods. The THINC-it comprised of: Spotter, Symbol Check, Codebreaker, Trails, and PDQ-5-D.
Vortioxetine: Observing change in cognition using THINC-it tool in patients with MDD.
THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:
Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)
|
Healthy Control Population
n=58 Participants
50 Healthy Controls (18-65 years of age) matched on sex, age, and years of education
THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:
Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.90 years
STANDARD_DEVIATION 12.74 • n=5 Participants
|
43.00 years
STANDARD_DEVIATION 13.89 • n=7 Participants
|
40.41 years
STANDARD_DEVIATION 13.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
68 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
100 participants
n=5 Participants
|
58 participants
n=7 Participants
|
158 participants
n=5 Participants
|
|
Baseline Montgomery Åsberg Depression Rating Scale (MADRS)
|
31.83 units on a scale
STANDARD_DEVIATION 7.54 • n=5 Participants
|
1.64 units on a scale
STANDARD_DEVIATION 2.41 • n=7 Participants
|
20.75 units on a scale
STANDARD_DEVIATION 5.66 • n=5 Participants
|
|
Baseline Digit Symbol Substitution Task Total Score (DSST)
|
56.05 units on a scale
STANDARD_DEVIATION 14.70 • n=5 Participants
|
61.21 units on a scale
STANDARD_DEVIATION 14.25 • n=7 Participants
|
57.94 units on a scale
STANDARD_DEVIATION 14.53 • n=5 Participants
|
|
Baseline Trail Making Test - Part B (TMT-B)
|
72.94 time (seconds)
STANDARD_DEVIATION 30.59 • n=5 Participants
|
70.59 time (seconds)
STANDARD_DEVIATION 29.14 • n=7 Participants
|
72.08 time (seconds)
STANDARD_DEVIATION 30.06 • n=5 Participants
|
|
Baseline THINC-it Tool Objective z-score
|
-0.05 z-score
STANDARD_DEVIATION 0.76 • n=5 Participants
|
-0.12 z-score
STANDARD_DEVIATION 0.82 • n=7 Participants
|
-0.08 z-score
STANDARD_DEVIATION 0.78 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: Participants were either lost to follow up or dropped out of the study.
Change in cognition as measured by the objective assessments of cognition within the THINC-it tool. "THINC-it" is the name of the cognition tool and is not an acronym. The objective measurements that comprise the THINC-it tool include the Spotter task (Choice Reaction Time), Symbol Check task(1-back test),Trails task(Trails Making Test B), and Codebreaker task (Digit Symbol Substitution Test). The composite score from all four tests were converted to standard z-score. Higher z-scores indicate better cognition. A z-score of zero indicates population mean.
Outcome measures
| Measure |
Healthy Control Participants
n=58 Participants
50 age, and sex-matched healthy controls who did not meet DSM-5 criteria for major depressive disorder
|
Major Depressive Disorder Population
n=100 Participants
100 Individuals with DSM-5-defined MDD, aged 18-65
All participants receiving vortioxetine for a total of 8 weeks. Participants will receive10 mg/day on days 1-14 of the study treatment period, with the option to increase to vortioxetine 20 mg/day at the end of Week 2 based on physician's judgment. For the remaining 6 weeks, the dose of vortioxetine will be flexible at 10 or 20 mg/day as decided by a research doctor.
Patients will receive the THINC-it over 3 time frame periods. The THINC-it comprised of: Spotter, Symbol Check, Codebreaker, Trails, and PDQ-5-D.
Vortioxetine: Observing change in cognition using THINC-it tool in patients with MDD.
THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:
Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)
|
|---|---|---|
|
Cognition Measured Using the THINC-it Tool
Week 0
|
-0.12 z-score
Standard Deviation 0.82
|
-0.05 z-score
Standard Deviation 0.76
|
|
Cognition Measured Using the THINC-it Tool
Week 8
|
0 z-score
Standard Deviation 0.77
|
0.12 z-score
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Participants dropped out or lost to follow-up.
Changes in mood assessed by the Montgomery Åsberg Depression Rating Scale \[MADRS\]. The overall score ranges from 0 to 60, where greater scores indicate worse depression.
Outcome measures
| Measure |
Healthy Control Participants
n=58 Participants
50 age, and sex-matched healthy controls who did not meet DSM-5 criteria for major depressive disorder
|
Major Depressive Disorder Population
n=99 Participants
100 Individuals with DSM-5-defined MDD, aged 18-65
All participants receiving vortioxetine for a total of 8 weeks. Participants will receive10 mg/day on days 1-14 of the study treatment period, with the option to increase to vortioxetine 20 mg/day at the end of Week 2 based on physician's judgment. For the remaining 6 weeks, the dose of vortioxetine will be flexible at 10 or 20 mg/day as decided by a research doctor.
Patients will receive the THINC-it over 3 time frame periods. The THINC-it comprised of: Spotter, Symbol Check, Codebreaker, Trails, and PDQ-5-D.
Vortioxetine: Observing change in cognition using THINC-it tool in patients with MDD.
THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:
Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)
|
|---|---|---|
|
Changes in Mood as Measured by the Montgomery Åsberg Depression Rating Scale (MADRS)
Week 8
|
1.02 units on a scale
Standard Deviation 1.78
|
20.39 units on a scale
Standard Deviation 10.66
|
|
Changes in Mood as Measured by the Montgomery Åsberg Depression Rating Scale (MADRS)
Week 0
|
1.64 units on a scale
Standard Deviation 2.41
|
31.83 units on a scale
Standard Deviation 7.54
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Participants dropped out or lost to follow-up.
Changes in cognition assessed by the Digit Symbol Substitution Task (DSST). The outcome measure is the number of correct symbols copied by the participants. Higher scores indicate better performance (minimum score is 0 and maximum is 133).
Outcome measures
| Measure |
Healthy Control Participants
n=58 Participants
50 age, and sex-matched healthy controls who did not meet DSM-5 criteria for major depressive disorder
|
Major Depressive Disorder Population
n=100 Participants
100 Individuals with DSM-5-defined MDD, aged 18-65
All participants receiving vortioxetine for a total of 8 weeks. Participants will receive10 mg/day on days 1-14 of the study treatment period, with the option to increase to vortioxetine 20 mg/day at the end of Week 2 based on physician's judgment. For the remaining 6 weeks, the dose of vortioxetine will be flexible at 10 or 20 mg/day as decided by a research doctor.
Patients will receive the THINC-it over 3 time frame periods. The THINC-it comprised of: Spotter, Symbol Check, Codebreaker, Trails, and PDQ-5-D.
Vortioxetine: Observing change in cognition using THINC-it tool in patients with MDD.
THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:
Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)
|
|---|---|---|
|
Changes in Cognitive Function Assessed by the Digit Symbol Substitution Task (DSST)
Week 0
|
61.21 units on a scale
Standard Deviation 14.27
|
56.05 units on a scale
Standard Deviation 14.70
|
|
Changes in Cognitive Function Assessed by the Digit Symbol Substitution Task (DSST)
Week 8
|
67.53 units on a scale
Standard Deviation 14.14
|
64.14 units on a scale
Standard Deviation 14.84
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Participants dropped out or lost to follow-up.
Changes in cognition assessed by the TMT-B. The outcome measure is time in seconds, where greater time indicates worse performance.
Outcome measures
| Measure |
Healthy Control Participants
n=58 Participants
50 age, and sex-matched healthy controls who did not meet DSM-5 criteria for major depressive disorder
|
Major Depressive Disorder Population
n=99 Participants
100 Individuals with DSM-5-defined MDD, aged 18-65
All participants receiving vortioxetine for a total of 8 weeks. Participants will receive10 mg/day on days 1-14 of the study treatment period, with the option to increase to vortioxetine 20 mg/day at the end of Week 2 based on physician's judgment. For the remaining 6 weeks, the dose of vortioxetine will be flexible at 10 or 20 mg/day as decided by a research doctor.
Patients will receive the THINC-it over 3 time frame periods. The THINC-it comprised of: Spotter, Symbol Check, Codebreaker, Trails, and PDQ-5-D.
Vortioxetine: Observing change in cognition using THINC-it tool in patients with MDD.
THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:
Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)
|
|---|---|---|
|
Changes in Cognitive Function Assessed by the Trail Making Test - Part B (TMT-B)
Week 0
|
70.60 seconds
Standard Deviation 29.14
|
72.95 seconds
Standard Deviation 30.60
|
|
Changes in Cognitive Function Assessed by the Trail Making Test - Part B (TMT-B)
Week 8
|
58.71 seconds
Standard Deviation 21.08
|
62.72 seconds
Standard Deviation 40.50
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Participants dropped out or lost to follow-up.
Sheehan Disability Scale rates the extent to which his or her 1) work, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. The numerical ratings of 0-10 can be translated into a percentage if desired. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).
Outcome measures
| Measure |
Healthy Control Participants
n=56 Participants
50 age, and sex-matched healthy controls who did not meet DSM-5 criteria for major depressive disorder
|
Major Depressive Disorder Population
n=100 Participants
100 Individuals with DSM-5-defined MDD, aged 18-65
All participants receiving vortioxetine for a total of 8 weeks. Participants will receive10 mg/day on days 1-14 of the study treatment period, with the option to increase to vortioxetine 20 mg/day at the end of Week 2 based on physician's judgment. For the remaining 6 weeks, the dose of vortioxetine will be flexible at 10 or 20 mg/day as decided by a research doctor.
Patients will receive the THINC-it over 3 time frame periods. The THINC-it comprised of: Spotter, Symbol Check, Codebreaker, Trails, and PDQ-5-D.
Vortioxetine: Observing change in cognition using THINC-it tool in patients with MDD.
THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:
Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)
|
|---|---|---|
|
Changes in Global Functional Impairment Using the Sheehan Disability Scale Total Score
Week 0
|
0.98 units on a scale
Standard Deviation 2.93
|
20.63 units on a scale
Standard Deviation 6.10
|
|
Changes in Global Functional Impairment Using the Sheehan Disability Scale Total Score
Week 8
|
1.3 units on a scale
Standard Deviation 4.35
|
14.64 units on a scale
Standard Deviation 8.48
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Participants dropped out or lost to follow-up.
The WHO-5 is a short questionnaire consisting of 5 simple and non-invasive questions, which tap into the subjective well-being of the respondents. The WHO-5 only contains positively phrased items. The respondent is asked to rate how well each of the 5 statements applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The raw score therefore theoretically ranges from 0 (absence of well-being) to 25 (maximal well-being). A percent score out of 25 is reported.
Outcome measures
| Measure |
Healthy Control Participants
n=57 Participants
50 age, and sex-matched healthy controls who did not meet DSM-5 criteria for major depressive disorder
|
Major Depressive Disorder Population
n=100 Participants
100 Individuals with DSM-5-defined MDD, aged 18-65
All participants receiving vortioxetine for a total of 8 weeks. Participants will receive10 mg/day on days 1-14 of the study treatment period, with the option to increase to vortioxetine 20 mg/day at the end of Week 2 based on physician's judgment. For the remaining 6 weeks, the dose of vortioxetine will be flexible at 10 or 20 mg/day as decided by a research doctor.
Patients will receive the THINC-it over 3 time frame periods. The THINC-it comprised of: Spotter, Symbol Check, Codebreaker, Trails, and PDQ-5-D.
Vortioxetine: Observing change in cognition using THINC-it tool in patients with MDD.
THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:
Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)
|
|---|---|---|
|
Changes in the World Health Organization Wellbeing Index (5-Item)
Week 0
|
72.42 percent of maximum score
Standard Deviation 16.42
|
15.24 percent of maximum score
Standard Deviation 11.45
|
|
Changes in the World Health Organization Wellbeing Index (5-Item)
Week 8
|
73.60 percent of maximum score
Standard Deviation 17.22
|
29.16 percent of maximum score
Standard Deviation 20.35
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Participants dropped out or lost to follow-up.
To establish sensitivity to change in anhedonia using the Snaith-Hamilton Pleasure Scale (SHAPS) total score in adults (18-65) with MDD treated with vortioxetine (10-20 mg flexibly dosed for 8 weeks). The SHAPS total score in adults ranges from 14 to 56. Higher score indicates more pleasure, with maximum of 56 points on the scale.
Outcome measures
| Measure |
Healthy Control Participants
n=57 Participants
50 age, and sex-matched healthy controls who did not meet DSM-5 criteria for major depressive disorder
|
Major Depressive Disorder Population
n=99 Participants
100 Individuals with DSM-5-defined MDD, aged 18-65
All participants receiving vortioxetine for a total of 8 weeks. Participants will receive10 mg/day on days 1-14 of the study treatment period, with the option to increase to vortioxetine 20 mg/day at the end of Week 2 based on physician's judgment. For the remaining 6 weeks, the dose of vortioxetine will be flexible at 10 or 20 mg/day as decided by a research doctor.
Patients will receive the THINC-it over 3 time frame periods. The THINC-it comprised of: Spotter, Symbol Check, Codebreaker, Trails, and PDQ-5-D.
Vortioxetine: Observing change in cognition using THINC-it tool in patients with MDD.
THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:
Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)
|
|---|---|---|
|
Changes in Changes in Anhedonia From Baseline to Week 8
Week 0
|
51.12 units on a scale
Standard Deviation 4.53
|
35.12 units on a scale
Standard Deviation 6.74
|
|
Changes in Changes in Anhedonia From Baseline to Week 8
Week 8
|
50.38 units on a scale
Standard Deviation 4.76
|
40.33 units on a scale
Standard Deviation 7.49
|
Adverse Events
Major Depressive Disorder Population
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
Healthy Control Population
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Major Depressive Disorder Population
n=100 participants at risk
100 Individuals with DSM-5-defined MDD, aged 18-65
All participants receiving vortioxetine for a total of 8 weeks. Participants will receive10 mg/day on days 1-14 of the study treatment period, with the option to increase to vortioxetine 20 mg/day at the end of Week 2 based on physician's judgment. For the remaining 6 weeks, the dose of vortioxetine will be flexible at 10 or 20 mg/day as decided by a research doctor.
Patients will receive the THINC-it over 3 time frame periods. The THINC-it comprised of: Spotter, Symbol Check, Codebreaker, Trails, and PDQ-5-D.
Vortioxetine: Observing change in cognition using THINC-it tool in patients with MDD.
THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:
Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)
|
Healthy Control Population
n=50 participants at risk
50 Healthy Controls (18-65 years of age) matched on sex, age, and years of education
THINC-it Tool: Digitalized cognitive test application administering the following cognitive test components:
Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
42.0%
42/100 • Number of events 42 • Adverse event data was collected during the 8-week trial from baseline to endpoint.
At each visit, participants were asked if they experienced any health problems or side effects since the previous visit. All adverse events (AE) were recorded appropriately, whether or not considered related to vortioxetine. This included AEs spontaneously reported by the participant and/or observed by members of the research team as well as AEs reported in response to a direct question (e.g. "Have you experienced any health problems or side effects since your last visit?")
|
0.00%
0/50 • Adverse event data was collected during the 8-week trial from baseline to endpoint.
At each visit, participants were asked if they experienced any health problems or side effects since the previous visit. All adverse events (AE) were recorded appropriately, whether or not considered related to vortioxetine. This included AEs spontaneously reported by the participant and/or observed by members of the research team as well as AEs reported in response to a direct question (e.g. "Have you experienced any health problems or side effects since your last visit?")
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
5/100 • Number of events 5 • Adverse event data was collected during the 8-week trial from baseline to endpoint.
At each visit, participants were asked if they experienced any health problems or side effects since the previous visit. All adverse events (AE) were recorded appropriately, whether or not considered related to vortioxetine. This included AEs spontaneously reported by the participant and/or observed by members of the research team as well as AEs reported in response to a direct question (e.g. "Have you experienced any health problems or side effects since your last visit?")
|
0.00%
0/50 • Adverse event data was collected during the 8-week trial from baseline to endpoint.
At each visit, participants were asked if they experienced any health problems or side effects since the previous visit. All adverse events (AE) were recorded appropriately, whether or not considered related to vortioxetine. This included AEs spontaneously reported by the participant and/or observed by members of the research team as well as AEs reported in response to a direct question (e.g. "Have you experienced any health problems or side effects since your last visit?")
|
|
Gastrointestinal disorders
Gastrointestinal Upset
|
16.0%
16/100 • Number of events 16 • Adverse event data was collected during the 8-week trial from baseline to endpoint.
At each visit, participants were asked if they experienced any health problems or side effects since the previous visit. All adverse events (AE) were recorded appropriately, whether or not considered related to vortioxetine. This included AEs spontaneously reported by the participant and/or observed by members of the research team as well as AEs reported in response to a direct question (e.g. "Have you experienced any health problems or side effects since your last visit?")
|
0.00%
0/50 • Adverse event data was collected during the 8-week trial from baseline to endpoint.
At each visit, participants were asked if they experienced any health problems or side effects since the previous visit. All adverse events (AE) were recorded appropriately, whether or not considered related to vortioxetine. This included AEs spontaneously reported by the participant and/or observed by members of the research team as well as AEs reported in response to a direct question (e.g. "Have you experienced any health problems or side effects since your last visit?")
|
|
Gastrointestinal disorders
Constipation
|
6.0%
6/100 • Number of events 6 • Adverse event data was collected during the 8-week trial from baseline to endpoint.
At each visit, participants were asked if they experienced any health problems or side effects since the previous visit. All adverse events (AE) were recorded appropriately, whether or not considered related to vortioxetine. This included AEs spontaneously reported by the participant and/or observed by members of the research team as well as AEs reported in response to a direct question (e.g. "Have you experienced any health problems or side effects since your last visit?")
|
0.00%
0/50 • Adverse event data was collected during the 8-week trial from baseline to endpoint.
At each visit, participants were asked if they experienced any health problems or side effects since the previous visit. All adverse events (AE) were recorded appropriately, whether or not considered related to vortioxetine. This included AEs spontaneously reported by the participant and/or observed by members of the research team as well as AEs reported in response to a direct question (e.g. "Have you experienced any health problems or side effects since your last visit?")
|
|
Nervous system disorders
Headache
|
15.0%
15/100 • Number of events 15 • Adverse event data was collected during the 8-week trial from baseline to endpoint.
At each visit, participants were asked if they experienced any health problems or side effects since the previous visit. All adverse events (AE) were recorded appropriately, whether or not considered related to vortioxetine. This included AEs spontaneously reported by the participant and/or observed by members of the research team as well as AEs reported in response to a direct question (e.g. "Have you experienced any health problems or side effects since your last visit?")
|
0.00%
0/50 • Adverse event data was collected during the 8-week trial from baseline to endpoint.
At each visit, participants were asked if they experienced any health problems or side effects since the previous visit. All adverse events (AE) were recorded appropriately, whether or not considered related to vortioxetine. This included AEs spontaneously reported by the participant and/or observed by members of the research team as well as AEs reported in response to a direct question (e.g. "Have you experienced any health problems or side effects since your last visit?")
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
5/100 • Number of events 5 • Adverse event data was collected during the 8-week trial from baseline to endpoint.
At each visit, participants were asked if they experienced any health problems or side effects since the previous visit. All adverse events (AE) were recorded appropriately, whether or not considered related to vortioxetine. This included AEs spontaneously reported by the participant and/or observed by members of the research team as well as AEs reported in response to a direct question (e.g. "Have you experienced any health problems or side effects since your last visit?")
|
0.00%
0/50 • Adverse event data was collected during the 8-week trial from baseline to endpoint.
At each visit, participants were asked if they experienced any health problems or side effects since the previous visit. All adverse events (AE) were recorded appropriately, whether or not considered related to vortioxetine. This included AEs spontaneously reported by the participant and/or observed by members of the research team as well as AEs reported in response to a direct question (e.g. "Have you experienced any health problems or side effects since your last visit?")
|
|
Nervous system disorders
Dizziness/Lightheadedness
|
13.0%
13/100 • Number of events 13 • Adverse event data was collected during the 8-week trial from baseline to endpoint.
At each visit, participants were asked if they experienced any health problems or side effects since the previous visit. All adverse events (AE) were recorded appropriately, whether or not considered related to vortioxetine. This included AEs spontaneously reported by the participant and/or observed by members of the research team as well as AEs reported in response to a direct question (e.g. "Have you experienced any health problems or side effects since your last visit?")
|
0.00%
0/50 • Adverse event data was collected during the 8-week trial from baseline to endpoint.
At each visit, participants were asked if they experienced any health problems or side effects since the previous visit. All adverse events (AE) were recorded appropriately, whether or not considered related to vortioxetine. This included AEs spontaneously reported by the participant and/or observed by members of the research team as well as AEs reported in response to a direct question (e.g. "Have you experienced any health problems or side effects since your last visit?")
|
|
Skin and subcutaneous tissue disorders
Itchiness
|
5.0%
5/100 • Number of events 5 • Adverse event data was collected during the 8-week trial from baseline to endpoint.
At each visit, participants were asked if they experienced any health problems or side effects since the previous visit. All adverse events (AE) were recorded appropriately, whether or not considered related to vortioxetine. This included AEs spontaneously reported by the participant and/or observed by members of the research team as well as AEs reported in response to a direct question (e.g. "Have you experienced any health problems or side effects since your last visit?")
|
0.00%
0/50 • Adverse event data was collected during the 8-week trial from baseline to endpoint.
At each visit, participants were asked if they experienced any health problems or side effects since the previous visit. All adverse events (AE) were recorded appropriately, whether or not considered related to vortioxetine. This included AEs spontaneously reported by the participant and/or observed by members of the research team as well as AEs reported in response to a direct question (e.g. "Have you experienced any health problems or side effects since your last visit?")
|
Additional Information
Dr. Roger McIntyre
Brain and Cognition Discovery Foundation
Phone: (416) 943-6284
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place