Status:
ACTIVE_NOT_RECRUITING
Unobtrusive Monitoring of Affective Symptoms and Cognition Using Keyboard Dynamics (UnMASCK)
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Mood Disorders
Major Depressive Disorder
Eligibility:
All Genders
25-50 years
Brief Summary
Mood disorders are associated with significant financial and health costs for the United States, partially due to cognitive problems in these patients that can worsen disease course and impair treatme...
Eligibility Criteria
Inclusion
- 25-50 years, as age-related declines in brain connectivity occur starting around 40-45 years of age (49-51);
- Participants must meet criteria for one of the following disorders according to Diagnostic and Statistical Manual of Mental Disorders-5 criteria (52): major depressive disorder (MDD), persistent depressive disorder (PDD), bipolar disorder (BD) type I/type II, cyclothymia. To ensure adequate representation across diagnostic categories (including controls), the investigators will cap enrollment of major mood disorders (MDD, BD type I/II) to 50%, PDD and cyclothymia to 25% and recruit a healthy comparison group to comprise the remaining 25% of the sample.
- Own a BiAffect-compatible smartphone.
Exclusion
- Active suicidal ideation as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)(50), suicide attempt in the last 3 months
- Severe cognitive impairment secondary to a neurological disorder (mild cognitive impairment, neurocognitive disorders, traumatic brain injury, developmental delay)
- Active moderate or severe alcohol and/or substance use disorders;
- Major medical or neurologic illness that would interfere with protocol adherence and/or interpretation of findings; and
- Presence of contraindications to MRI.
- Pregnancy (positive pregnancy test), trying to become pregnant, or lactation.
Key Trial Info
Start Date :
September 17 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04358900
Start Date
September 17 2020
End Date
November 30 2025
Last Update
September 4 2025
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612