Major Depressive DisorderPhase 2/3NCT03053362
THINC-it Vortioxetine - Sensitivity to Change
A Phase 2/3 study testing Vortioxetine and THINC-it Tool in people with Major Depressive Disorder and Cognitive Change, run by Brain and Cognition Discovery Foundation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Cognitive Change
- What is being tested?
- Vortioxetine and THINC-it Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteCanada
- Study dates
- 24 May 2017to 8 Aug 2018
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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.
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- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Clinical Trial Evaluating Sensitivity to Change in Cognition Using the THINC-it Following Treatment With Vortioxetine in Major Depressive Disorder
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.
Read the 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.
- Conditions
- Major Depressive Disorder, Cognitive Change
- Being tested
- Vortioxetine, THINC-it Tool
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
Observing change in cognition using THINC-it tool in patients with MDD.
THINC-it ToolOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Major Depressive Disorder Population | Experimental | 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. Receives: Drug: Vortioxetine; Other: THINC-it Tool |
| Healthy Control Population | Other | 50 Healthy Controls (18-65 years of age) matched on sex, age, and years of education Receives: Other: THINC-it Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition Measured Using the THINC-it Tool
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.
Measured: Baseline and 8 weeks
Secondary outcomes (6)
Changes in Mood as Measured by the Montgomery Åsberg Depression Rating Scale (MADRS)
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.
Measured: Baseline and 8 weeks
Changes in Cognitive Function Assessed by the Digit Symbol Substitution Task (DSST)
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).
Measured: Baseline and 8 weeks
Changes in Cognitive Function Assessed by the Trail Making Test - Part B (TMT-B)
Changes in cognition assessed by the TMT-B. The outcome measure is time in seconds, where greater time indicates worse performance.
Measured: Baseline and 8 weeks
Changes in Global Functional Impairment Using the Sheehan Disability Scale Total Score
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).
Measured: Baseline and 8 weeks
Changes in the World Health Organization Wellbeing Index (5-Item)
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.
Measured: Baseline and 8 weeks
Changes in Changes in Anhedonia From Baseline to Week 8
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start24 May 2017
- Primary completion8 Aug 2018
- Study completion8 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Determining the effectiveness of a new tool used to detect changes in cognition among individuals with MDD.
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain and Cognition Discovery Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger McIntyre, Principal investigator, Brain and Cognition Discovery Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053362
- Sponsor's protocol ID
- Pro00020418
- Status last verified
- May 2025
- First submitted
- 7 Feb 2017
- Last updated
- 8 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McIntyre RS, Subramaniapillai M, Park C, Zuckerman H, Cao B, Lee Y, Iacobucci M, Nasri F, Fus D, Bowie CR, Tran T, Rosenblat JD, Mansur RB. The THINC-it Tool for Cognitive Assessment and Measurement in Major Depressive Disorder: Sensitivity to Change. Front Psychiatry. 2020 Jun 24;11:546. doi: 10.3389/fpsyt.2020.00546. eCollection 2020.
PubMed 32670103Subramaniapillai M, Mansur RB, Zuckerman H, Park C, Lee Y, Iacobucci M, Cao B, Ho R, Lin K, Phan L, McIntyre RS. Association between cognitive function and performance on effort based decision making in patients with major depressive disorder treated with Vortioxetine. Compr Psychiatry. 2019 Oct;94:152113. doi: 10.1016/j.comppsych.2019.07.006. Epub 2019 Jul 24.
PubMed 31404802Cao B, Park C, Subramaniapillai M, Lee Y, Iacobucci M, Mansur RB, Zuckerman H, Phan L, McIntyre RS. The Efficacy of Vortioxetine on Anhedonia in Patients With Major Depressive Disorder. Front Psychiatry. 2019 Jan 31;10:17. doi: 10.3389/fpsyt.2019.00017. eCollection 2019.
PubMed 30766492
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Clinical Trial Evaluating Sensitivity to Change in Cognition Using the THINC-it Following Treatment With Vortioxetine in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03053362
- Acronym / sponsor ID
- Pro00020418
- Conditions
- Major Depressive Disorder, Cognitive Change
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Brain and Cognition Discovery FoundationUniversity, hospital or other
- Study start
- 24 May 2017 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 8 Aug 2018 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Posted 20 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Determining the effectiveness of a new tool used to detect changes in cognition among individuals with MDD.
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Disorder Population | Experimental | Drug: Vortioxetine, Other: THINC-it Tool100 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. |
| Healthy Control Population | Other | Other: THINC-it Tool50 Healthy Controls (18-65 years of age) matched on sex, age, and years of education |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VortioxetineObserving change in cognition using THINC-it tool in patients with MDD. | Drug | Major Depressive Disorder Population |
| THINC-it ToolDigitalized 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, Major Depressive Disorder Population |
Primary outcome
Cognition Measured Using the THINC-it Tool
Time frame: 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.
6 secondary outcomes
Changes in Mood as Measured by the Montgomery Åsberg Depression Rating Scale (MADRS)
Time frame: Baseline and 8 weeks
Changes in Cognitive Function Assessed by the Digit Symbol Substitution Task (DSST)
Time frame: Baseline and 8 weeks
Changes in Cognitive Function Assessed by the Trail Making Test - Part B (TMT-B)
Time frame: Baseline and 8 weeks
Changes in Global Functional Impairment Using the Sheehan Disability Scale Total Score
Time frame: Baseline and 8 weeks
Changes in the World Health Organization Wellbeing Index (5-Item)
Time frame: Baseline and 8 weeks
Changes in Changes in Anhedonia From Baseline to Week 8
Time frame: Baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32670103McIntyre RS, Subramaniapillai M, Park C, Zuckerman H, Cao B, Lee Y, Iacobucci M, Nasri F, Fus D, Bowie CR, Tran T, Rosenblat JD, Mansur RB. The THINC-it Tool for Cognitive Assessment and Measurement in Major Depressive Disorder: Sensitivity to Change. Front Psychiatry. 2020 Jun 24;11:546. doi: 10.3389/fpsyt.2020.00546. eCollection 2020.
- Derived from this study: PubMed 31404802Subramaniapillai M, Mansur RB, Zuckerman H, Park C, Lee Y, Iacobucci M, Cao B, Ho R, Lin K, Phan L, McIntyre RS. Association between cognitive function and performance on effort based decision making in patients with major depressive disorder treated with Vortioxetine. Compr Psychiatry. 2019 Oct;94:152113. doi: 10.1016/j.comppsych.2019.07.006. Epub 2019 Jul 24.
- Derived from this study: PubMed 30766492Cao B, Park C, Subramaniapillai M, Lee Y, Iacobucci M, Mansur RB, Zuckerman H, Phan L, McIntyre RS. The Efficacy of Vortioxetine on Anhedonia in Patients With Major Depressive Disorder. Front Psychiatry. 2019 Jan 31;10:17. doi: 10.3389/fpsyt.2019.00017. eCollection 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger McIntyre principal investigator
Brain and Cognition Discovery Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vortioxetine and THINC-it Tool in people with Major Depressive Disorder and Cognitive Change, run by Brain and Cognition Discovery Foundation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition Measured Using the THINC-it Tool (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03053362, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.