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

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.