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Validation of the THINC-it Tool for Cognitive Dysfunction in Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02508493
Recruitment Status : Completed
First Posted : July 27, 2015
Last Update Posted : September 15, 2016
Sponsor:
Collaborators:
Co-Principal Investigators: Dr. Roger S. McIntyre & Dr. John Harrison
Imperial College London
Information provided by (Responsible Party):
Dr. Roger S. McIntyre, Brain and Cognition Discovery Foundation

Tracking Information
First Submitted Date July 22, 2015
First Posted Date July 27, 2015
Last Update Posted Date September 15, 2016
Study Start Date November 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 2, 2015)
  • 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 ]
Original Primary Outcome Measures
 (submitted: July 23, 2015)
  • Composite THINC Tool Score [ Time Frame: up to1 week ]
    The composite THINC tool score is the integrated total score of results from performance on five sub-component cognitive tests of the THINC tool.
  • Digit Symbol Substitution Test (DSST) - THINC tool version [ Time Frame: Up to 1 week ]
  • Choice Reaction Time (CRT) - THINC tool version [ Time Frame: Up to 1 week ]
  • 1-back working memory test - THINC tool version [ Time Frame: Up to 1 week ]
  • Trail Making Test B - THINC tool version [ Time Frame: Up to 1 week ]
  • Perceived Deficits Questionnaire 5 item for depression (PDQ-5-D) - THINC 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 ]
  • 1-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 ]
Change History
Current Secondary Outcome Measures
 (submitted: July 23, 2015)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of the THINC-it Tool for Cognitive Dysfunction in Major Depressive Disorder
Official Title Validation of the THINC-it Tool for Cognitive Dysfunction in Major Depressive Disorder
Brief 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 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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.

Condition Major Depressive Disorder
Intervention
  • 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: Pencil-and-paper Cognitive Tests

    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 Groups/Cohorts
  • Major Depressive Disorder Population
    100 Individuals with DSM-5-defined MDD, aged 18-65
    Interventions:
    • Other: THINC-it Tool
    • Other: Pencil-and-paper Cognitive Tests
  • Healthy Control Population
    100 healthy controls matched on age, sex and years of education
    Interventions:
    • Other: THINC-it Tool
    • Other: Pencil-and-paper Cognitive Tests
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: July 23, 2015)
200
Original Estimated Enrollment Same as current
Actual Study Completion Date July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

MDD Population:

Inclusion Criteria:

  • 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.
  • 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.

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 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.
  • 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:

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02508493
Other Study ID Numbers BCDF-THINC.it
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Roger S. McIntyre, Brain and Cognition Discovery Foundation
Study Sponsor Brain and Cognition Discovery Foundation
Collaborators
  • Co-Principal Investigators: Dr. Roger S. McIntyre & Dr. John Harrison
  • Imperial College London
Investigators
Principal Investigator: Roger McIntyre Brain and Cognition Discovery Foundation
PRS Account Brain and Cognition Discovery Foundation
Verification Date September 2016