Ignite Creation Date:
2024-05-06 @ 6:04 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05531591
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-18
First Post:
2022-08-19
Brief Title:
RCT of Brain Longitudinal Biomarker Study OPT-Neuro RCT
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
RCT of Neurocognitive and Neuroimaging Biomarkers Predicting Progression Towards Dementia in Patients With Treatment-resistant Late-life Depression OPTIMUM-Neuro RCT
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ONR
Brief Summary:
The purpose of this study is to assess which antidepressants work the best in older adults who have treatment-resistant depression TRD and to test whether treatment-resistant late life depression is associated with declines in memory and attention and brain structure and function
Detailed Description:
Older adult participants with treatment-resistant depression will be randomly assigned to a Step 1 medication strategy
Adding aripiprazole to current antidepressant medication
Adding bupropion to current antideprssant medication
Replacing current antidepressant medication with bupropion
If depression is not relieved at the end of 10 weeks or if participants do not qualify for Step 1 participants will be randomly assigned to a Step 2 medication strategy
Adding lithium to current antidepressant medication
Replacing current antidepressant medication with nortriptyline
All medication strategies will be offered in collaboration with participants own physicians with the the research team providing support and guidance
After treatment in Step 1 andor Step 2 participants will enter the Continuation Phase to assess long term follow-up outcomes for 12 months
Participants in the Optimizing Outcomes of Treatment-Resistant Depression in Older Adults OPTIMUM NCT02960763 study will also be asked to participate in this clinical trial to gather imaging and biomarker data The study will test if changes in brain structure and function are associated with decreases in memory In this study investigators will conduct a series of assessmentstests mainly brain imaging and assessments of participants memory and attention to better understand how depression is linked to memory and thinking in older persons
Investigators will be collecting blood biomarkers as part of their study procedures These samples will be used to look at other factors that may relate to depression or memory and attention processes
Mechanisms of Late life depression LLD-dementia through functional Magnetic Resonance Imaging fMRI Analyzing mechanisms of the LLD-dementia relationship through fMRI acquisitions and analyses to capture the specific brain networks implicated in executive function and episodic memory decline
Neuropsychological Data Including Montreal Cognitive Assessment MoCA Wide Range Achievement Test-4 WRAT-4 Reading subtest Repeatable Battery for the Assessment of Neuropsychological Status RBANS and Delis-Kaplan Executive Function System D-KEFS Color Word Interference Trail Making and Verbal Fluency
Clinical Scales Including the Everyday Cognition Scale E-Cog Global Clinical Dementia Rating CDR Performance Assessment of Selfcare Skills PASS-Cognitive Instrumental Activities of Daily LivingCIADL Short version Patient Health Questionnaire PHQ-9 and Suicide Risk Assessments Suicide Questions Baseline Suicidal Ideation Suicide Intent Scale Beck Lethality Scale Decision Outcome Inventory Columbia-Suicide Severity Rating Scale and High Suicide Risk Protocol
Investigators hope that this study will help the scientific community to understand why some people with depressive symptoms that are resistant to treatment in late-life experience declines in their memory and attention and whether effective treatment of such depression reduces that risk Finally investigators hope that this study will eventually lead to the development of better treatment options
Adding aripiprazole to current antidepressant medication
Adding bupropion to current antideprssant medication
Replacing current antidepressant medication with bupropion
If depression is not relieved at the end of 10 weeks or if participants do not qualify for Step 1 participants will be randomly assigned to a Step 2 medication strategy
Adding lithium to current antidepressant medication
Replacing current antidepressant medication with nortriptyline
All medication strategies will be offered in collaboration with participants own physicians with the the research team providing support and guidance
After treatment in Step 1 andor Step 2 participants will enter the Continuation Phase to assess long term follow-up outcomes for 12 months
Participants in the Optimizing Outcomes of Treatment-Resistant Depression in Older Adults OPTIMUM NCT02960763 study will also be asked to participate in this clinical trial to gather imaging and biomarker data The study will test if changes in brain structure and function are associated with decreases in memory In this study investigators will conduct a series of assessmentstests mainly brain imaging and assessments of participants memory and attention to better understand how depression is linked to memory and thinking in older persons
Investigators will be collecting blood biomarkers as part of their study procedures These samples will be used to look at other factors that may relate to depression or memory and attention processes
Mechanisms of Late life depression LLD-dementia through functional Magnetic Resonance Imaging fMRI Analyzing mechanisms of the LLD-dementia relationship through fMRI acquisitions and analyses to capture the specific brain networks implicated in executive function and episodic memory decline
Neuropsychological Data Including Montreal Cognitive Assessment MoCA Wide Range Achievement Test-4 WRAT-4 Reading subtest Repeatable Battery for the Assessment of Neuropsychological Status RBANS and Delis-Kaplan Executive Function System D-KEFS Color Word Interference Trail Making and Verbal Fluency
Clinical Scales Including the Everyday Cognition Scale E-Cog Global Clinical Dementia Rating CDR Performance Assessment of Selfcare Skills PASS-Cognitive Instrumental Activities of Daily LivingCIADL Short version Patient Health Questionnaire PHQ-9 and Suicide Risk Assessments Suicide Questions Baseline Suicidal Ideation Suicide Intent Scale Beck Lethality Scale Decision Outcome Inventory Columbia-Suicide Severity Rating Scale and High Suicide Risk Protocol
Investigators hope that this study will help the scientific community to understand why some people with depressive symptoms that are resistant to treatment in late-life experience declines in their memory and attention and whether effective treatment of such depression reduces that risk Finally investigators hope that this study will eventually lead to the development of better treatment options
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH114970 | NIH | None | None |
| R01MH114980 | NIH | None | None |
| R01MH114981 | NIH | None | None |
| R01MH114966-01 | NIH | None | httpsreporternihgovquickSearchR01MH114966-01 |