Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT02508493
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02508493
Study Brief:
Protocol Section:
NCT02508493