THINC-it Vortioxetine - Sensitivity to Change
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the sensitivity of the THINC-it tool, in measuring change in cognitive deficits in individuals with MDD after receiving vortioxetine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
Vortioxetine is used in this study as an antidepressant to improve mood, cognition and quality of life. "Cognition" refers to intellectual functions such as thinking, understanding, learning and remembering. Vortioxetine is approved by Health Canada for the treatment of MDD. In addition, vortioxetine has been reported to have a beneficial effect on cognitive areas such as executive function, attention/speed of processing, and memory, that are commonly affected negatively by MDD. Vortioxetine is recognized by Health Authorities in the EU and many other countries as having a benefit on cognitive dysfunction (loss of intellectual functions) in patients with MDD.Cognitive dysfunction is a highly persistent, pervasive and progressive abnormality in young adults (i.e., 18-65 years) with MDD.
It has also been shown that among adults with MDD who are gainfully employed, measures of cognition are a greater determinant of overall workplace performance than is total depression symptom severity. Several lines of evidence indicate that cognitive deficits that persist between episodes of depression are critical determinants of functional recovery in the workplace. The functional implications associated with cognitive impairment provide the impetus for systematic evaluation, measurement and assessment of the domains of cognition expected to be impaired in this patient population.
To date, no measurement tool has been sufficiently validated and/or determined to be sensitive to the cognitive deficits in younger adults with MDD. Major limitations of available comprehensive psychometric tools include relative lack of availability, cost, lack of access to most healthcare providers, and above all else, the lengthy time to administer. Moreover, the need for a psychometrist to interpret the results adds to the complexity and the costliness of such an endeavor.
It is imperative that any tool recommended for clinical utility be aligned with the busy nature of a high-volume clinical practice. The ideal gold standard tool for assessing the presence of cognitive dysfunction in MDD in the clinical environment should include, but not be limited to, features such as good conceptual coverage of cognitive domains affected in MDD, good sensitivity and reliability, and it should be relatively uninfluenced by culture effects and practice effects. The tool would also need to be brief, easy to administer and interpret, and complement busy clinical practice.
It is anticipated that the THINC-it tool will be free of charge and downloadable from the THINC-it website for use in the primary care and specialty setting. The THINC-it tool will be accessible via computers/tablets, will take 20 minutes to self-administer in a clinical setting, and the performance results will be immediately available.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Vortioxetine
Observing change in cognition using THINC-it tool in patients with MDD.
Other: 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)
|
| Other: Healthy Control Population 50 Healthy Controls (18-65 years of age) matched on sex, age, and years of education |
Other: 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)
|
Outcome Measures
Primary Outcome Measures
- Cognition Measured Using the THINC-it Tool [Baseline and 8 weeks]
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.
Secondary Outcome Measures
- Changes in Mood as Measured by the Montgomery Åsberg Depression Rating Scale (MADRS) [Baseline and 8 weeks]
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.
- Changes in Cognitive Function Assessed by the Digit Symbol Substitution Task (DSST) [Baseline and 8 weeks]
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).
- Changes in Cognitive Function Assessed by the Trail Making Test - Part B (TMT-B) [Baseline and 8 weeks]
Changes in cognition assessed by the TMT-B. The outcome measure is time in seconds, where greater time indicates worse performance.
- Changes in Global Functional Impairment Using the Sheehan Disability Scale Total Score [Baseline and 8 weeks]
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).
- Changes in the World Health Organization Wellbeing Index (5-Item) [Baseline and 8 weeks]
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.
- Changes in Changes in Anhedonia From Baseline to Week 8 [Baseline and 8 weeks]
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). Higher score indicates more pleasure, with maximum of 56 points on the scale.
Eligibility Criteria
Criteria
MDD Population
Inclusion Criteria:
-
The participant is able and willing to provide informed consent.
-
The participant is male or female 18-65 years of age.
-
The participant has received a current diagnosis of a major depressive episode (MDE) as part of MDD as per DSM-5 criteria.
-
The participant's current MDE is confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I 5.0.).
-
The participant is an outpatient of a psychiatric setting.
-
The participant has a MADRS score ≥ 26 at screening and baseline.
-
The participant's reported duration of the current MDE is at least 3 months.
-
At least one prior major depressive episode validated by previous treatment (e.g., guideline-informed pharmacotherapy and/or manual-based psychotherapy).
-
All participants will be screened for cognitive impairment based on DSST performance (pen-and-paper version) with a maximum baseline score of 70 correct symbols entered to avoid ceiling effects.
Exclusion Criteria:
-
Current alcohol and/or substance use disorder.
-
Presence of comorbid psychiatric disorder other than MDD that is a focus of clinical concern as confirmed by the M.I.N.I 5.0.
-
Medications approved and/or employed off-label for cognitive dysfunction (e.g., psychostimulants).
-
Any medication for a general medical disorder that, in the opinion of the investigator, may affect cognitive function (e.g., corticosteroids, beta-blockers).
-
Use of benzodiazepines within 12 hours of cognitive assessments.
-
Consumption of alcohol within 8 hours of cognitive assessments.
-
Recent use of marijuana as determined by a toxicology screen.
-
Physical, cognitive, or language impairments sufficient to adversely affect data derived from cognitive assessments.
-
Diagnosis reading disability or dyslexia.
-
Clinically significant learning disorder by history.
-
Electroconvulsive therapy (ECT) in the last 6 months.
-
History of moderate or severe head trauma (e.g., loss of consciousness for >1 hour), other neurological disorders, or unstable systemic medical diseases that in the opinion of the investigator are likely to affect the central nervous system.
-
Pregnant and/or breastfeeding.
-
Received investigational agents as part of a separate study within 30 days of the screening visit.
-
Actively suicidal or evaluated as being a suicide risk (a score of > 4 on the MADRS and/or per clinical judgment using the Columbia-Suicide Severity Rating Scale).
-
Currently receiving treatment with Monoamine Oxidase Inhibitors (MAOIs) anti-depressants, antibiotics such as linezolid, or intravenous methylene blue.
Healthy Control Population
Inclusion Criteria:
-
No current or past history of mental disorder as evidenced by the M.I.N.I. 5.0 for DSM-IV.
-
No first-degree relative with an established diagnosis by a healthcare provider of a mood or psychiatric disorder.
-
No unstable medical disorders.
Exclusion Criteria:
-
Use of any medication for a general medical disorder and/or condition that, in the opinion of the investigator, may affect cognitive function (e.g., corticosteroids, beta-blockers).
-
Pregnant and/or breastfeeding.
-
Consumption of alcohol within 8 hours of THINC-it tool administration.
-
Recent use of marijuana as determined by a toxicology screen.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CRTCE/KJK Healthplex | Toronto | Ontario | Canada | L5C 4E7 |
Sponsors and Collaborators
- Brain and Cognition Discovery Foundation
Investigators
- Principal Investigator: Roger McIntyre, Brain and Cognition Discovery Foundation
Study Documents (Full-Text)
More Information
Publications
None provided.- Pro00020418
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Major Depressive Disorder Population | Healthy Control Population |
|---|---|---|
| Arm/Group Description | 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) | 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) |
| Period Title: Overall Study | ||
| STARTED | 100 | 58 |
| COMPLETED | 83 | 50 |
| NOT COMPLETED | 17 | 8 |
Baseline Characteristics
| Arm/Group Title | Major Depressive Disorder Population | Healthy Control Population | Total |
|---|---|---|---|
| Arm/Group Description | 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) | 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 of all reporting groups |
| Overall Participants | 100 | 58 | 158 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
38.90
(12.74)
|
43.00
(13.89)
|
40.41
(13.16)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
67
67%
|
27
46.6%
|
94
59.5%
|
| Male |
33
33%
|
31
53.4%
|
64
40.5%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| White |
68
68%
|
20
34.5%
|
88
55.7%
|
| Asian |
11
11%
|
16
27.6%
|
27
17.1%
|
| Other |
21
21%
|
22
37.9%
|
43
27.2%
|
| Region of Enrollment (participants) [Number] | |||
| Canada |
100
100%
|
58
100%
|
158
100%
|
| Baseline Montgomery Åsberg Depression Rating Scale (MADRS) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
31.83
(7.54)
|
1.64
(2.41)
|
20.75
(5.66)
|
| Baseline Digit Symbol Substitution Task Total Score (DSST) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
56.05
(14.70)
|
61.21
(14.25)
|
57.94
(14.53)
|
| Baseline Trail Making Test - Part B (TMT-B) (time (seconds)) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [time (seconds)] |
72.94
(30.59)
|
70.59
(29.14)
|
72.08
(30.06)
|
| Baseline THINC-it Tool Objective z-score (z-score) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [z-score] |
-0.05
(0.76)
|
-0.12
(0.82)
|
-0.08
(0.78)
|
Outcome Measures
| Title | Cognition Measured Using the THINC-it Tool |
|---|---|
| Description | 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. |
| Time Frame | Baseline and 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants were either lost to follow up or dropped out of the study. |
| Arm/Group Title | Major Depressive Disorder Population | Healthy Control Population |
|---|---|---|
| Arm/Group Description | 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) | 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) |
| Measure Participants | 100 | 58 |
| Week 0 |
-0.05
(0.76)
|
-0.12
(0.82)
|
| Week 8 |
0.12
(0.73)
|
0
(0.77)
|
| Title | Changes in Mood as Measured by the Montgomery Åsberg Depression Rating Scale (MADRS) |
|---|---|
| Description | 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. |
| Time Frame | Baseline and 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants dropped out or lost to follow-up. |
| Arm/Group Title | Major Depressive Disorder Population | Healthy Control Participants |
|---|---|---|
| Arm/Group Description | 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) | 50 age, and sex-matched healthy controls who did not meet DSM-5 criteria for major depressive disorder |
| Measure Participants | 99 | 58 |
| Week 0 |
31.83
(7.54)
|
1.64
(2.41)
|
| Week 8 |
20.39
(10.66)
|
1.02
(1.78)
|
| Title | Changes in Cognitive Function Assessed by the Digit Symbol Substitution Task (DSST) |
|---|---|
| Description | 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). |
| Time Frame | Baseline and 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants dropped out or lost to follow-up. |
| Arm/Group Title | Major Depressive Disorder Population | Healthy Control Participants |
|---|---|---|
| Arm/Group Description | 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) | 50 age, and sex-matched healthy controls who did not meet DSM-5 criteria for major depressive disorder |
| Measure Participants | 100 | 58 |
| Week 0 |
56.05
(14.70)
|
61.21
(14.27)
|
| Week 8 |
64.14
(14.84)
|
67.53
(14.14)
|
| Title | Changes in Cognitive Function Assessed by the Trail Making Test - Part B (TMT-B) |
|---|---|
| Description | Changes in cognition assessed by the TMT-B. The outcome measure is time in seconds, where greater time indicates worse performance. |
| Time Frame | Baseline and 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants dropped out or lost to follow-up. |
| Arm/Group Title | Major Depressive Disorder Population | Healthy Control Participants |
|---|---|---|
| Arm/Group Description | 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) | 50 age, and sex-matched healthy controls who did not meet DSM-5 criteria for major depressive disorder |
| Measure Participants | 99 | 58 |
| Week 0 |
72.95
(30.60)
|
70.60
(29.14)
|
| Week 8 |
62.72
(40.50)
|
58.71
(21.08)
|
| Title | Changes in Global Functional Impairment Using the Sheehan Disability Scale Total Score |
|---|---|
| Description | 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). |
| Time Frame | Baseline and 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants dropped out or lost to follow-up. |
| Arm/Group Title | Major Depressive Disorder Population | Healthy Control Participants |
|---|---|---|
| Arm/Group Description | 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) | 50 age, and sex-matched healthy controls who did not meet DSM-5 criteria for major depressive disorder |
| Measure Participants | 100 | 56 |
| Week 0 |
20.63
(6.10)
|
0.98
(2.93)
|
| Week 8 |
14.64
(8.48)
|
1.3
(4.35)
|
| Title | Changes in the World Health Organization Wellbeing Index (5-Item) |
|---|---|
| Description | 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. |
| Time Frame | Baseline and 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants dropped out or lost to follow-up. |
| Arm/Group Title | Major Depressive Disorder Population | Healthy Control Participants |
|---|---|---|
| Arm/Group Description | 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) | 50 age, and sex-matched healthy controls who did not meet DSM-5 criteria for major depressive disorder |
| Measure Participants | 100 | 57 |
| Week 0 |
15.24
(11.45)
|
72.42
(16.42)
|
| Week 8 |
29.16
(20.35)
|
73.60
(17.22)
|
| Title | Changes in Changes in Anhedonia From Baseline to Week 8 |
|---|---|
| Description | 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). Higher score indicates more pleasure, with maximum of 56 points on the scale. |
| Time Frame | Baseline and 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants dropped out or lost to follow-up. |
| Arm/Group Title | Major Depressive Disorder Population | Healthy Control Participants |
|---|---|---|
| Arm/Group Description | 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) | 50 age, and sex-matched healthy controls who did not meet DSM-5 criteria for major depressive disorder |
| Measure Participants | 99 | 57 |
| Week 0 |
35.12
(6.74)
|
51.12
(4.53)
|
| Week 8 |
40.33
(7.49)
|
50.38
(4.76)
|
Adverse Events
| Time Frame | Adverse event data was collected during the 8-week trial from baseline to endpoint. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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?") | |||
| Arm/Group Title | Major Depressive Disorder Population | Healthy Control Population | ||
| Arm/Group Description | 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) | 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) | ||
All Cause Mortality |
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| Major Depressive Disorder Population | Healthy Control Population | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/100 (0%) | 0/50 (0%) | ||
Serious Adverse Events |
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| Major Depressive Disorder Population | Healthy Control Population | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/100 (0%) | 0/50 (0%) | ||
Other (Not Including Serious) Adverse Events |
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| Major Depressive Disorder Population | Healthy Control Population | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 53/100 (53%) | 0/50 (0%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 42/100 (42%) | 42 | 0/50 (0%) | 0 |
| Vomiting | 5/100 (5%) | 5 | 0/50 (0%) | 0 |
| Gastrointestinal Upset | 16/100 (16%) | 16 | 0/50 (0%) | 0 |
| Constipation | 6/100 (6%) | 6 | 0/50 (0%) | 0 |
| Diarrhea | 5/100 (5%) | 5 | 0/50 (0%) | 0 |
| Nervous system disorders | ||||
| Headache | 15/100 (15%) | 15 | 0/50 (0%) | 0 |
| Dizziness/Lightheadedness | 13/100 (13%) | 13 | 0/50 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Itchiness | 5/100 (5%) | 5 | 0/50 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Roger McIntyre |
|---|---|
| Organization | Brain and Cognition Discovery Foundation |
| Phone | (416) 943-6284 |
| rogermcintyre28@gmail.com |
- Pro00020418