ACE-D Aim 3 Clinical Cognitive Trial to Enhance Translation in Depression

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT06408246

Run by

Stanford University

People needed

162

Starts

2026-03-03

Expected to finish

2029-02-01

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and lifestyle considerations (see Section 5.3) and availability for the duration of the study
• Male or female
• Age 18-60 years
• Fluent and literate in English
• Meets DSM-5-TR diagnostic criteria for MDE (major depressive episode), and criteria for current or recurrent nonpsychotic MDD using the Mini International Neuropsychiatric Interview (MINI Plus)79
• A total score of 10 or higher on the PHQ-8 at initial screening, including:
• a. Endorsement of anhedonia, as indexed by a response of "more than half the days" or "nearly every day" to Item 1 ("Little interest or pleasure in doing things") or endorsement of persistent negative mood, as indexed by a response of "more than half the days" or "nearly every day" to Item 2 ("Feeling down, depressed, or hopeless")
• Meets criteria for cognitive dysfunction (C+ subgroup) or absence of cognitive dysfunction (C- subgroup) based on results from computerized behavioral testing of cognitive control performance (WebNeuro) and from fMRI scanning using the Go/No-Go task.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Presence of one or more of the following conditions established via the participant's medical record and confirmed using the MINI Plus:
• bipolar disorder (I, II, not otherwise specified, current or lifetime)
• psychosis (current or lifetime)
• moderate to severe alcohol or substance use disorders (current)
• post-traumatic stress disorder (PTSD; current)
• obsessive compulsive disorder (OCD; current or lifetime)
• attention deficit hyperactivity disorder (ADHD; current or lifetime)
• eating disorders (ED; current)
• Suicidality with active plan
• Severe impediment to vision, hearing, and/or hand movement
• Current or lifetime history of medical illness or brain injury that may interfere with assessments
• Pregnant, breastfeeding, or unwilling or unable to use adequate birth control throughout the study (females of child-bearing potential only)
• 3.0T MRI scanner contraindications (e.g., metal in the body, claustrophobia)
• Concurrent participation in other intervention studies
• Current use of psychotropic medications contraindicated by guanfacine or sertraline
• General medical condition or disorder that is deemed by study physicians to be unsafe for GIR as reported by patient or found on medical screening. This may include:
• Cardiac-related exclusions:
• Resting heart rate (HR) < 55 beats per minute (bradycardia)
• Systolic blood pressure (SBP) < 90 mmHg or diastolic blood pressure (DBP) < 60 mmHg (hypotension)
• Current symptoms suggestive of cardiac dysfunction based on clinician assessment (e.g., persistent chest pain, palpitations, dizziness, fainting)
• Renal-related exclusions:
• eGFR < 60 mL/min/1.73 m²
• Current symptoms suggestive of kidney dysfunction based on clinician assessment
• Hepatic-related exclusions:

Where it is running

• Stanford Psychiatry and Behavioral Sciences Department — Palo Alto, California, United States (enrolling)
• University of Illinois at Chicago — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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