Sertraline + Guanfacine for Depression

(ACE-D Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Leanne Williams, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Leanne Williams, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for individuals experiencing symptoms of depression. Specific eligibility criteria are not provided, but typically participants must meet diagnostic criteria for the condition being studied and may need to pass certain health assessments to qualify.

Inclusion Criteria

Written informed consent

Meets criteria for cognitive impairment (<=-.5 standard deviation below healthy norms) or intact cognition (within healthy range) subgroups based on a computerized behavioral tests of cognitive control performance (WebNeuro) relative to healthy norms

Fluent and literate in English

Exclusion Criteria

Suicidal ideations representing imminent risk, defined by a score of ≥ 8 on the MINI Plus, or by clinician judgement

History of a DSM-5 bipolar disorder (I, II, not otherwise specified) or psychosis (current or lifetime) established via the participant's medical record and confirmed using the MINI Plus as necessary

History of DSM-5 alcohol or substance use disorder in the last 6 months established via the participant's medical record and confirmed using the MINI Plus as necessary

Treatment Details

Interventions

• Guanfacine (Alpha-2 Adrenergic Agonist)

Trial Overview The study investigates how guanfacine, a psychotropic medication, affects brain network functioning in people with depressive symptoms. It also examines the interaction between this drug's effects on brain function and cognitive impairments associated with depression.

Participant Groups

Group I: Sertraline + Placebo Experimental Treatment 1 Intervention

We will conduct a parallel-group, double-blind randomized trial at Stanford Bay Area and Chicago sites, identifying 160 participants with a prominent clinical cognitive signature (C+) and relative absence of the signature (C-). We will enrich for C+, the signature of interest, at a 2:1 ratio. Participants will be randomly assigned to receive guanfacine (shown to ameliorate cognitive control deficits in our preliminary data) plus sertraline or placebo plus sertraline.

Group II: Sertraline + Guanfacine Experimental Treatment 1 Intervention

We will conduct a parallel-group, double-blind randomized trial at Stanford Bay Area and Chicago sites, identifying 160 participants with a prominent clinical cognitive signature (C+) and relative absence of the signature (C-). We will enrich for C+, the signature of interest, at a 2:1 ratio. Participants will be randomly assigned to receive guanfacine (shown to ameliorate cognitive control deficits in our preliminary data) plus sertraline or placebo plus sertraline.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Illinois at Chicago Chicago, IL

Stanford Psychiatry and Behavioral Sciences Department Palo Alto, CA

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2527

Patients Recruited

17,430,000+