Ignite Creation Date:
2024-05-06 @ 9:22 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02960763
Status:
COMPLETED
Last Update Posted:
2022-11-29
First Post:
2016-10-28
Brief Title:
Optimizing Outcomes of Treatment-Resistant Depression in Older Adults
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Optimizing Outcomes of Treatment-Resistant Depression in Older Adults
Status:
COMPLETED
Status Verified Date:
2024-09
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:
OPTIMUM
Brief Summary:
The purpose of this research study is to assess which antidepressants work the best in older adults who have treatment-resistant depression TRD
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 antidepressant 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 this clinical trial will also be asked to participate in an additional study to gather imaging and biomarker data
Adding aripiprazole to current antidepressant medication
Adding bupropion to current antidepressant 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 this clinical trial will also be asked to participate in an additional study to gather imaging and biomarker data
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 |
|---|---|---|---|
| TRD-1511-33321 | OTHER_GRANT | PCORI | None |