Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408246
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-06
Brief Title:
Stanford and University of Illinois Chicago ACE-D Study
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
ACE-D Accelerating Cognition-guided Signatures to Enhance Translation in Depression Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
ACE-D
Brief Summary:
The purpose of this study is to understand how a psychotropic medication called guanfacine affects brain network functioning in humans and how this function interacts with cognitive impairments in people experiencing depressive symptoms
Detailed Description:
The investigators will conduct a parallel-group double-blind randomized trial at Stanford Bay Area and Chicago sites identifying 160 participants across Stanford University and the University of Illinois Chicago with a prominent clinical cognitive signature C and relative absence of the signature C-
If you are eligible and choose to participate based off of your answers on the screening survey the investigators will call you on the number you have provided to verify participants responses and answer any additional questions you may have about the study
The first screening visit will consist of obtaining participants informed consent to participate in the study completing cognitive testing answering questions about participants thoughts and feelings and providing information about participants medical and psychiatric history In addition this initial screening visit will consist of undergoing an EKG with a medical professional
If participants are deemed eligible at this phase the investigators will ask participants to come in for another in-person visit 3 hours that would involve a non-invasive brain scan If a participant Is eligible they will be randomized to receive guanfacine plus sertraline or placebo plus sertraline for an 8 week treatment phase
Starting week 1 and for every other week during the 8-week treatment phase participants will complete surveys passive sampling with the BiAffect application and conduct cognitive testing Additionally starting week 2 and every other week thereafter participants will conduct a virtual or in-person physician visit At the end of week 8 the investigators will conduct an MRI visit that resembles the initial MRI visit Participants will be unblinded over weeks 9-10 to arrange for the participants transition out of the trial
If you are eligible and choose to participate based off of your answers on the screening survey the investigators will call you on the number you have provided to verify participants responses and answer any additional questions you may have about the study
The first screening visit will consist of obtaining participants informed consent to participate in the study completing cognitive testing answering questions about participants thoughts and feelings and providing information about participants medical and psychiatric history In addition this initial screening visit will consist of undergoing an EKG with a medical professional
If participants are deemed eligible at this phase the investigators will ask participants to come in for another in-person visit 3 hours that would involve a non-invasive brain scan If a participant Is eligible they will be randomized to receive guanfacine plus sertraline or placebo plus sertraline for an 8 week treatment phase
Starting week 1 and for every other week during the 8-week treatment phase participants will complete surveys passive sampling with the BiAffect application and conduct cognitive testing Additionally starting week 2 and every other week thereafter participants will conduct a virtual or in-person physician visit At the end of week 8 the investigators will conduct an MRI visit that resembles the initial MRI visit Participants will be unblinded over weeks 9-10 to arrange for the participants transition out of the trial
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?:
True
Is an FDA AA801 Violation?:
None