Depression in Old AgeREMBRANDTNCT05331599
Recurrence Markers, Cognitive Burden and Neurobiological Homeostasis in Late-Life Depression
An observational study of Depression in Old Age and Recurrence, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression in Old Age, Recurrence, Cognitive Dysfunction
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 15 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will enroll patients from clinical referrals and response to advertisements. For clinical referrals, referring providers may either provide information about the study to the participant, including our contact information. Alternatively, they may obtain permission from the participant for the study team to contact them. With the clinician's agreement, study staff can review their clinic schedules to help identify potentially eligible patients, however data will not be recorded for research purposes. Advertisements may include radio, newspapers, internet, online research registries, public transportation, and flyers / brochures.
Who may be able to join
- 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.
Who cannot join
- 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, epilepsy, etc.; 8) Presence of unstable medical illness requiring urgent treatment; 9) Any MRI contraindication; 10) ECT in last 6 months; 11) Vagal Nerve Stimulation within 6 months of study entry; 12) Current use of TMS, ketamine, or esketamine with plans to continue treatment.
- Remitted depressed participants (who will directly enter the longitudinal study): Identical to the currently depressed participants, plus 1) currently receiving brain stimulation treatment (ECT, TMS, VNS), ketamine or esketamine. There are no other exclusions for antidepressant treatment.
- Never- depressed elders: Identical to the currently depressed participants, plus: 1) No diagnosis of current or past depressive disorder or other Axis I disorder except for simple phobia; 2) No history of psychotropic medication use for psychiatric symptoms.
- We will not be enrolling vulnerable populations, specifically pregnant women, children, prisoners, or institutionalized individuals. We also will not enroll subjects incapable of providing their own consent. Should a potential subject present where there is a concern (either by a study clinician or staff member) about their ability to understand study procedures and provide meaningful consent, their cognitive ability and understanding will be evaluated by a study doctor. If there is any concern that the individual may be impaired, they will not be enrolled in the study. The rationale will be provided to the individual as well as his or her family members. Referrals for further evaluation, including urgent or emergent evaluation, will be made as needed and clinically warranted.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60607
About this study
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.
- Conditions
- Depression in Old Age, Recurrence, Cognitive Dysfunction
- Keywords
- Depression in Old Age, Recurrence, Antidepressive Agents, Depression, Neurobiological Markers, Cognitive Dysfunction, Anxiety Depression
- Medical subject headings
- Recurrence, Cognitive Dysfunction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Currently Depressed Participants | Individuals who are currently depressed and receive treatment through an antidepressant treatment | |
| Remitted Depressed Participants | Individuals who have achieved remission from depression within 4 months | |
| Remitted Depressed Elders | Individuals who no lifetime history of depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurobiology of Recurrence (Stress Reactivity)
Stress reactivity measured experimentally (neural reactivity during fMRI stress induction task) and ecologically (affective instability by ecological momentary assessment).
Measured: Change in stress reactivity at Month 8, Month 16, and Month 24
Neurobiology of Recurrence (Functional Network Connectivity)
Alterations in functional network connectivity which includes both intra/internetwork connectivity markers and well as markers of network instability.
Measured: Change in functional network connectivity at Month 8, Month 16, and Month 24
Secondary outcomes (1)
Change in Cognitive Function
Cognition will be assessed a conventional, broad-based battery.
Measured: Change in cognitive function at Month 0 and Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Jun 2020
- Primary completion15 May 2025
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in Old AgeStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Pittsburgh, Vanderbilt University Medical Center
- Responsible party
- Principal investigator, Olusola Alade Ajilore, University of Illinois Chicago
- Investigators
- Amruta Barve, MPH, Study chair, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331599
- Sponsor's protocol ID
- 2020-0078
- Other IDs
- 1R01MH121384-01
- Acronym
- REMBRANDT
- Status last verified
- Aug 2025
- First submitted
- 8 Apr 2020
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence Markers, Cognitive Burden and Neurobiological Homeostasis in Late-Life Depression
- ClinicalTrials.gov ID
- NCT05331599
- Acronym / sponsor ID
- REMBRANDT / 2020-0078
- Conditions
- Depression in Old Age, Recurrence, Cognitive Dysfunction
- Keywords
- Depression in Old Age, Recurrence, Antidepressive Agents, Depression, Neurobiological Markers, Cognitive Dysfunction, Anxiety Depression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Pittsburgh, Vanderbilt University Medical Center
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Currently Depressed Participants | – | –Individuals who are currently depressed and receive treatment through an antidepressant treatment |
| Remitted Depressed Participants | – | –Individuals who have achieved remission from depression within 4 months |
| Remitted Depressed Elders | – | –Individuals who no lifetime history of depression |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll patients from clinical referrals and response to advertisements. For clinical referrals, referring providers may either provide information about the study to the participant, including our contact information. Alternatively, they may obtain permission from the participant for the study team to contact them. With the clinician's agreement, study staff can review their clinic schedules to help identify potentially eligible patients, however data will not be recorded for research purposes. Advertisements may include radio, newspapers, internet, online research registries, public transportation, and flyers / brochures.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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, epilepsy, etc.; 8) Presence of unstable medical illness requiring urgent treatment; 9) Any MRI contraindication; 10) ECT in last 6 months; 11) Vagal Nerve Stimulation within 6 months of study entry; 12) Current use of TMS, ketamine, or esketamine with plans to continue treatment.
- Remitted depressed participants (who will directly enter the longitudinal study): Identical to the currently depressed participants, plus 1) currently receiving brain stimulation treatment (ECT, TMS, VNS), ketamine or esketamine. There are no other exclusions for antidepressant treatment.
- Never- depressed elders: Identical to the currently depressed participants, plus: 1) No diagnosis of current or past depressive disorder or other Axis I disorder except for simple phobia; 2) No history of psychotropic medication use for psychiatric symptoms.
- We will not be enrolling vulnerable populations, specifically pregnant women, children, prisoners, or institutionalized individuals. We also will not enroll subjects incapable of providing their own consent. Should a potential subject present where there is a concern (either by a study clinician or staff member) about their ability to understand study procedures and provide meaningful consent, their cognitive ability and understanding will be evaluated by a study doctor. If there is any concern that the individual may be impaired, they will not be enrolled in the study. The rationale will be provided to the individual as well as his or her family members. Referrals for further evaluation, including urgent or emergent evaluation, will be made as needed and clinically warranted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurobiology of Recurrence (Stress Reactivity)
Time frame: Change in stress reactivity at Month 8, Month 16, and Month 24
Stress reactivity measured experimentally (neural reactivity during fMRI stress induction task) and ecologically (affective instability by ecological momentary assessment).
Neurobiology of Recurrence (Functional Network Connectivity)
Time frame: Change in functional network connectivity at Month 8, Month 16, and Month 24
Alterations in functional network connectivity which includes both intra/internetwork connectivity markers and well as markers of network instability.
1 secondary outcome
Change in Cognitive Function
Time frame: Change in cognitive function at Month 0 and Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amruta Barve, MPH study chair
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression in Old Age and Recurrence, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurobiology of Recurrence (Stress Reactivity) (time frame: Change in stress reactivity at Month 8, Month 16, and Month 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.