NCT05877885 Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
| NCT ID | NCT05877885 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AdventHealth |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2025-09-19 |
| Primary Completion | 2028-11-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 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. 9. Total score of \> 29 on the Telephone Interview for Cognitive Status (TICS) 10. Eligible to undergo MRI 11. Access to a computer or tablet with Wifi capabilities