Major Depressive DisorderNCT02508493
Validation of the THINC-it Tool for Cognitive Dysfunction in Major Depressive Disorder
An observational study of Major Depressive Disorder, run by Brain and Cognition Discovery Foundation at 1 site in Canada.
Trial summary
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… 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
- What is being tested?
- THINC-it Tool and Pencil-and-paper Cognitive Tests
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All patients will be enrolled at a single site, located in Toronto, Ontario, Canada. The total planned number of participants is: * 100 individuals with DSM-5-defined MDD, aged 18-65 * 100 healthy controls matched on age, sex and years of education An equal allocation of subjects with MDD between the ages of 18-44 and 45-65 will be enrolled. Healthy controls will be consecutively recruited via media announcements.
Who may be able to join
- That participant is able and willing to provide informed consent.
- The participant is male or female between the ages of 18-65.
- The participant has received a diagnosis of a major depressive disorder (MDE) as per DSM-5 criteria.
- Current MDE is confirmed by the MINI for DSM-IV-TR.
- The participant is an outpatient at a psychiatric setting.
- The participant has a MADRS score equal to or greater than 22.
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- The reported duration of current depressive episode is at least 3 months.
- The participant has been receiving a stable antidepressant dose for a minimum of 2 weeks prior to the study visit.
- At least one prior episode by history of depression validated by previous treatment (e.g. guidelines-informed pharmacotherapy and/or manual-based psychotherapy).
- Health Canada-approved antidepressant; add-on agents commensurate with Canadian (i.e. CANMAT) and American treatment-guidelines for MDD will be permitted.
- Enrollment in manual-based and/or supportive psychotherapy will be permitted.
- No current or past history of mental disorder as evidence by MINI or DSM-IV-TR.
- 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 MINI for DSM-IV-TR.
- Medications approved for 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 THINC-it tool administration.
- Consumption of alcohol within 8 hours of THINC-it tool administration.
Show all 14Show fewer
- The patient has physical, cognitive, or language impairment of some severity as to adversely affect the validity of the data derived from neuropsychological tests.
- The patient is diagnosed with a reading disability or dyslexia.
- The patient cannot have a clinically significant learning disorder by history.
- The patient has received electroconvulsive therapy (ECT) in the last 6 months.
- The patient has a history of moderate or severe head trauma (e.g. loss of consciousness for over 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.
- Healthy Controls:
- Any medication for a general medical disorder that in the opinion of the investigator may affect cognitive function (e.g. corticosteroids, beta-blockers).
- Consumption of alcohol within 8 hours of THINC-it tool administration.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
This study is designed to validate a brief user-friendly tool capable of detecting deficit in cognitive performance among adults with MDD. Data will be gathered with the aim to determine whether the proposed tool identifies cognitive deficits in adults with MDD and differentiates the clinical MDD population from healthy controls.
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
- Being tested
- THINC-it Tool, Pencil-and-paper Cognitive Tests
- 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.
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)
Pencil-and-paper Cognitive TestsOther
Pencil-and-paper versions of the following cognitive tests:
- Digit Symbol Substitution Test (DSST)
- Trail Making Test B (TMT-B)
- Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)
- Variant of Choice Reaction Time (CRT)
- Variant of the One-back working memory tool
| Study group | Role | What they receive |
|---|---|---|
| Major Depressive Disorder Population | 100 Individuals with DSM-5-defined MDD, aged 18-65 Receives: Other: THINC-it Tool; Other: Pencil-and-paper Cognitive Tests | |
| Healthy Control Population | 100 healthy controls matched on age, sex and years of education Receives: Other: THINC-it Tool; Other: Pencil-and-paper Cognitive Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite THINC-it Tool Score
The composite THINC-it tool score is the integrated total score of results from performance on five sub-component cognitive tests of the THINC-it tool.
Measured: up to1 week
Digit Symbol Substitution Test (DSST) - THINC-it tool version
Measured: Up to 1 week
Choice Reaction Time (CRT) - THINC-it tool version
Measured: Up to 1 week
One-back working memory test - THINC-it tool version
Measured: Up to 1 week
Trail Making Test B - THINC-it tool version
Measured: Up to 1 week
Perceived Deficits Questionnaire 5 item for depression (PDQ-5-D) - THINC-it tool version
Measured: Up to 1 week
Digit Symbol Substitution Test (DSST) - Pencil-and-paper version
Measured: Up to 1 week
Choice Reaction Time (CRT) - Pencil-and-paper version
Measured: Up to 1 week
One-back working memory test - Pencil-and-paper version
Measured: Up to 1 week
Trail Making Test B - Pencil-and-paper version
Measured: Up to 1 week
Perceived Deficits Questionnaire 5 item for depression (PDQ-5-D) - Pencil-and paper version
Measured: Up to 1 week
Secondary outcomes (8)
Endicott Workplace Productivity Scale (EWPS)
Measured: Up to 1 week
Sheehan Disability Scale (SDS)
Measured: Up to 1 week
Pittsburgh Sleep Quality Index (PSQI)
Measured: Up to 1 week
Clinical Global Impression (CGI)
Measured: Administered at one timepoint to healthy controls and to subjects with MDD after administration of primary cognitive test instruments.
Montgomery Asberg Depression Rating Scale (MADRS)
Measured: Up to 1 week
Generalized Anxiety Disorder 7-Item (GAD-7)
Measured: Administered at one timepoint to healthy controls and to subjects with MDD after administration of primary cognitive test instruments.
WHO-5 Well-being Index (WHO-5)
Measured: Up to 1 week
Visual Analog Scale (VAS)
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brain and Cognition Discovery Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Co-Principal Investigators: Dr. Roger S. McIntyre & Dr. John Harrison, Imperial College London
- Responsible party
- Principal investigator, Roger McIntyre, Brain and Cognition Discovery Foundation
- Investigators
- Roger McIntyre, Principal investigator, Brain and Cognition Discovery Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508493
- Sponsor's protocol ID
- BCDF-THINC.it
- Status last verified
- Oct 2021
- First submitted
- 22 Jul 2015
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Cha DS, Carmona N, Cha RH, Zhou AJ, Subramaniapillai M, Mansur RB, Lee Y, Lee JH, Lee J, Almatham F, Alageel A, Rosenblat JD, Shekotikhina M, Rong C, Harrison J, McIntyre RS. Perceived sleep quality predicts cognitive function in adults with major depressive disorder independent of depression severity. Ann Clin Psychiatry. 2019 Feb;31(1):17-26.
PubMed 30372511Cha DS, Carmona NE, Rodrigues NB, Mansur RB, Lee Y, Subramaniapillai M, Phan L, Cha RH, Pan Z, Lee JH, Lee J, Almatham F, Alageel A, Rosenblat JD, Shekotikhina M, Rong C, Harrison J, McIntyre RS. Cognitive impairment as measured by the THINC-integrated tool (THINC-it): The association with self-reported anxiety in Major Depressive Disorder. J Affect Disord. 2018 Oct 1;238:228-232. doi: 10.1016/j.jad.2018.05.006. Epub 2018 Jun 1.
PubMed 29886204Carmona NE, Subramaniapillai M, Mansur RB, Cha DS, Lee Y, Fus D, McIntyre RS. Sex differences in the mediators of functional disability in Major Depressive Disorder. J Psychiatr Res. 2018 Jan;96:108-114. doi: 10.1016/j.jpsychires.2017.09.025. Epub 2017 Sep 30.
PubMed 28992527McIntyre RS, Best MW, Bowie CR, Carmona NE, Cha DS, Lee Y, Subramaniapillai M, Mansur RB, Barry H, Baune BT, Culpepper L, Fossati P, Greer TL, Harmer C, Klag E, Lam RW, Wittchen HU, Harrison J. The THINC-Integrated Tool (THINC-it) Screening Assessment for Cognitive Dysfunction: Validation in Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jul;78(7):873-881. doi: 10.4088/JCP.16m11329.
PubMed 28858441
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the THINC-it Tool for Cognitive Dysfunction in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02508493
- Acronym / sponsor ID
- BCDF-THINC.it
- Conditions
- Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Brain and Cognition Discovery FoundationUniversity, hospital or other
- Collaborators
- Co-Principal Investigators: Dr. Roger S. McIntyre & Dr. John Harrison, Imperial College London
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
This study is designed to validate a brief user-friendly tool capable of detecting deficit in cognitive performance among adults with MDD. Data will be gathered with the aim to determine whether the proposed tool identifies cognitive deficits in adults with MDD and differentiates the clinical MDD population from healthy controls.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Disorder Population | – | Other: THINC-it Tool, Other: Pencil-and-paper Cognitive Tests100 Individuals with DSM-5-defined MDD, aged 18-65 |
| Healthy Control Population | – | Other: THINC-it Tool, Other: Pencil-and-paper Cognitive Tests100 healthy controls matched on age, sex and years of education |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients will be enrolled at a single site, located in Toronto, Ontario, Canada. The total planned number of participants is: * 100 individuals with DSM-5-defined MDD, aged 18-65 * 100 healthy controls matched on age, sex and years of education An equal allocation of subjects with MDD between the ages of 18-44 and 45-65 will be enrolled. Healthy controls will be consecutively recruited via media announcements.
Key inclusion criteria (14 listed)
- That participant is able and willing to provide informed consent.
- The participant is male or female between the ages of 18-65.
- The participant has received a diagnosis of a major depressive disorder (MDE) as per DSM-5 criteria.
- Current MDE is confirmed by the MINI for DSM-IV-TR.
- The participant is an outpatient at a psychiatric setting.
Key exclusion criteria (14 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 MINI for DSM-IV-TR.
- Medications approved for 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 THINC-it tool administration.
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 |
|---|---|---|
| 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 |
| Pencil-and-paper Cognitive TestsPencil-and-paper versions of the following cognitive tests: * Digit Symbol Substitution Test (DSST) * Trail Making Test B (TMT-B) * Perceived Deficits Questionnaire-5 Depression (PDQ-5-D) * Variant of Choice Reaction Time (CRT) * Variant of the One-back working memory tool | Other | Healthy Control Population, Major Depressive Disorder Population |
Primary outcome
Composite THINC-it Tool Score
Time frame: up to1 week
The composite THINC-it tool score is the integrated total score of results from performance on five sub-component cognitive tests of the THINC-it tool.
Digit Symbol Substitution Test (DSST) - THINC-it tool version
Time frame: Up to 1 week
Choice Reaction Time (CRT) - THINC-it tool version
Time frame: Up to 1 week
One-back working memory test - THINC-it tool version
Time frame: Up to 1 week
Trail Making Test B - THINC-it tool version
Time frame: Up to 1 week
Perceived Deficits Questionnaire 5 item for depression (PDQ-5-D) - THINC-it tool version
Time frame: Up to 1 week
Digit Symbol Substitution Test (DSST) - Pencil-and-paper version
Time frame: Up to 1 week
Choice Reaction Time (CRT) - Pencil-and-paper version
Time frame: Up to 1 week
One-back working memory test - Pencil-and-paper version
Time frame: Up to 1 week
Trail Making Test B - Pencil-and-paper version
Time frame: Up to 1 week
Perceived Deficits Questionnaire 5 item for depression (PDQ-5-D) - Pencil-and paper version
Time frame: Up to 1 week
8 secondary outcomes
Endicott Workplace Productivity Scale (EWPS)
Time frame: Up to 1 week
Sheehan Disability Scale (SDS)
Time frame: Up to 1 week
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Up to 1 week
Clinical Global Impression (CGI)
Time frame: Administered at one timepoint to healthy controls and to subjects with MDD after administration of primary cognitive test instruments.
Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: Up to 1 week
Generalized Anxiety Disorder 7-Item (GAD-7)
Time frame: Administered at one timepoint to healthy controls and to subjects with MDD after administration of primary cognitive test instruments.
WHO-5 Well-being Index (WHO-5)
Time frame: Up to 1 week
Visual Analog Scale (VAS)
Time frame: Up to 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Derived from this study: PubMed 30372511Cha DS, Carmona N, Cha RH, Zhou AJ, Subramaniapillai M, Mansur RB, Lee Y, Lee JH, Lee J, Almatham F, Alageel A, Rosenblat JD, Shekotikhina M, Rong C, Harrison J, McIntyre RS. Perceived sleep quality predicts cognitive function in adults with major depressive disorder independent of depression severity. Ann Clin Psychiatry. 2019 Feb;31(1):17-26.
- Derived from this study: PubMed 29886204Cha DS, Carmona NE, Rodrigues NB, Mansur RB, Lee Y, Subramaniapillai M, Phan L, Cha RH, Pan Z, Lee JH, Lee J, Almatham F, Alageel A, Rosenblat JD, Shekotikhina M, Rong C, Harrison J, McIntyre RS. Cognitive impairment as measured by the THINC-integrated tool (THINC-it): The association with self-reported anxiety in Major Depressive Disorder. J Affect Disord. 2018 Oct 1;238:228-232. doi: 10.1016/j.jad.2018.05.006. Epub 2018 Jun 1.
- Derived from this study: PubMed 28992527Carmona NE, Subramaniapillai M, Mansur RB, Cha DS, Lee Y, Fus D, McIntyre RS. Sex differences in the mediators of functional disability in Major Depressive Disorder. J Psychiatr Res. 2018 Jan;96:108-114. doi: 10.1016/j.jpsychires.2017.09.025. Epub 2017 Sep 30.
- Derived from this study: PubMed 28858441McIntyre RS, Best MW, Bowie CR, Carmona NE, Cha DS, Lee Y, Subramaniapillai M, Mansur RB, Barry H, Baune BT, Culpepper L, Fossati P, Greer TL, Harmer C, Klag E, Lam RW, Wittchen HU, Harrison J. The THINC-Integrated Tool (THINC-it) Screening Assessment for Cognitive Dysfunction: Validation in Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jul;78(7):873-881. doi: 10.4088/JCP.16m11329.
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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?
An observational study of Major Depressive Disorder, 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 14 inclusion and 14 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 27 Oct 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite THINC-it Tool Score (time frame: up to1 week). The study lists 11 primary outcomes in all. 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 NCT02508493, which also lists 4 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 27 Oct 2021.