Stanford and University of Illinois Chicago ACE-D Study — ACE-D  

Depression Clinical Trial

Official title: ACE-D: Accelerating Cognition-guided Signatures to Enhance Translation in Depression: Clinical Trial

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Depression

• NCT number: NCT06408246
• Study type: Interventional
• Source: Stanford University
• Contact: Leyla Boyar, BA
• Phone: 6504989326
• Email: ljboyar@stanford.edu
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 1, 2026
• Completion date: February 1, 2029