Recurrence Markers, Cognitive Burden and Neurobiological Homeostasis in Late-Life Depression (NCT05331599) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Recurrence Markers, Cognitive Burden and Neurobiological Homeostasis in Late-Life Depression
United States210 participantsStarted 2020-06-01
Plain-language summary
Late-life depression (LLD) is associated with disability, increased risk for cognitive decline and dementia, elevated suicide risk, and greater all-cause mortality. These outcomes are related to depression being a recurrent disorder, with repeated episodes over a patient's lifetime. Recurrence rates (defined as including both relapse and recurrence) are high in LLD.
The goals of this study are to identify neurobiological factors that predict recurrence risk, and examine how cognitive performance changes are both influenced by these neurobiological factors and also predict recurrence risk.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Currently depressed participants (who will enter the treatment algorithm): 1) Age \> 60 years; 2) diagnosis of major depressive disorder, recurrent episode (DSM5); 3) severity: Montgomery Asberg Depression Rating Scale (MADRS) (67) ≥ 15; 4) cognition: Montreal Cognitive Assessment (MoCA) \>24 or Montreal Cognitive Assessment (MoCA) - BLIND ≥ 18; 5) fluent in English.
* Remitted depressed participants (who will directly enter the longitudinal study): 1) Age \> 60 years; 2) diagnosis of major depressive disorder, recurrent, in partial or full remission (DSM5); 3) severity: MADRS \< 10; 4) cognition: MoCA \>24 or Montreal Cognitive Assessment (MoCA) - BLIND ≥ 18; 5) fluent in English.
* Never- depressed elders: 1) Age \> 60 years; 2) severity: MADRS \< 8; 3) cognition: MoCA \>24 or MoCA - BLIND ≥ 18; 4) fluent in English.
Exclusion Criteria:
* Currently depressed participants (who will enter the treatment algorithm): 1) Other Axis I psychiatric disorders, except for simple phobia or anxiety disorders present during the depressive episode (e.g., generalized anxiety disorder (GAD) or panic disorder symptoms); 2) History of alcohol or drug dependence or abuse (other than nicotine) in the last year; 3) History of a developmental disorder or history of IQ \< 70; 4) Acute suicidality within 3 months of study entry; 5) Acute grief (\<1 month); 6) Current or past psychosis; 7) Primary neurological disorder, including dementia, clinical stroke, brain tumor, epile…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neurobiology of Recurrence (Stress Reactivity)
Timeframe: Change in stress reactivity at Month 8, Month 16, and Month 24
2
Neurobiology of Recurrence (Functional Network Connectivity)
Timeframe: Change in functional network connectivity at Month 8, Month 16, and Month 24