RecruitingMajor Depressive DisorderApathy
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Eligible age
60+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
The goal of this randomized controlled trial is to evaluate the potential of a customized digital cognitive training intervention to target aspects of brain function in apathy of late-life depression and reduce symptoms of apathy and related cognitive and behavioral deficits. The investigators hypothesize that 4 weeks of a customized digital cognitive training program will lead to changes in brain connectivity, apathy severity, and cognitive control performance.
Sponsor: AdventHealth
You may qualify if…
- ✓ 1. Age 60+ years
- ✓ 2. Diagnosis of unipolar major depressive disorder without psychotic features, as assessed by the Mini International Neuropsychiatric Interview
- ✓ 3. Montgomery-Åsberg Depression Rating Scale (MADRS) score \> or = 16.
- ✓ 4. Clinically significant apathy, determined by the Clinician-rated Apathy Evaluation Scale (C-AES \> or = to 37)
- ✓ 5. Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 5 weeks.
- ✓ 6. On a stable dose of other psychotropic medications, deemed by the investigator to be associated with brain networks of interest, for at least 8 weeks.
- ✓ 7. Capacity to provide written consent for research assessment and treatment
- ✓ 8. Ability to follow written and verbal instructions (English) as assessed by the PI and/or study staff.
You may not qualify if…
- ✕ 1. History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, persistent depressive disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia
- ✕ 2. Use of cholinesterase inhibitors or psychoactive drugs other than antidepressants or benzodiazepines, including antipsychotics, that in the opinion of the Investigator may confound study data/assessments.
- ✕ 3. Presence or history of significant neurologic or neurodegenerative disorder (e.g., Alzheimer's disease and other dementias, amnestic Mild Cognitive Impairment, history of stroke, Multiple Sclerosis, Parkinson's disease, epilepsy).
- ✕ 4. Any other acute medical condition (e.g., cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease; metastatic cancer; or debilitated states or less common medical illnesses) that may influence brain systems of interest or interfere with participation or interpretation of the study results.
- ✕ 5. Participant is currently considered at risk for attempting suicide by the Investigator, has made a suicide attempt within the past year, or is currently demonstrating active suicidal ideation or self-injurious behavior.
- ✕ 6. Electroconvulsive therapy within the past 12 months
- ✕ 7. Recent history (within 6 months prior to screening/baseline) of Substance Use Disorder.
- ✕ 8. Participant is currently enrolled in ongoing concurrent cognitive rehabilitation (note that if a subject is enrolled in psychotherapy, this will not be grounds for exclusion)
Where it's recruiting
Florida
Orlando
Source: ClinicalTrials.gov · NCT05877885 · last updated 2025-10-22