Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics

Launched by ADVENTHEALTH · May 17, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new digital program designed to help older adults with major depression and feelings of apathy, which is a lack of interest or motivation. The researchers want to see if this customized digital cognitive training can improve brain function, reduce symptoms of apathy, and enhance thinking and behavior over a period of four weeks. They believe that participating in this program could lead to better connections in the brain and help participants feel more engaged and active in their daily lives.

To be eligible for the trial, participants need to be 60 years or older and have a diagnosis of major depressive disorder without any psychotic features. They should also experience significant apathy and be stable on their antidepressant medication for at least eight weeks. Participants will need access to a computer or tablet with Wi-Fi, be able to follow instructions in English, and be willing to undergo some testing, including an MRI if needed. The trial is not yet recruiting participants, but for those who qualify, it offers a chance to explore an innovative approach to managing symptoms of depression and apathy.

Gender

ALL

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
• • 12. Able to comply with all testing and study requirements and willingness to participate in the full study duration.
• Exclusion Criteria:
• • 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)
• • 9. Claustrophobia
• • 10. Color Blindness
• • 11. Sensory or physical impairment that would preclude cognitive testing or participation in the intervention (e.g., upper limb paralysis) as reported by the participant or observed by the Investigator.
• • 12. Travelling consecutively for 2+ weeks during the study period to a location that will preclude timely collection of post-treatment MRI data.
• • 13. Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, cochlear implant, any other metallic biomedical implant contraindicating to MRI.