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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Accelerating Cognition-guided Signatures to Enhance Translation in Depression Aim 3: Clinical Cognitive Trial

ACE-D Aim 3 Clinical Cognitive Trial to Enhance Translation in Depression (NCT06408246) is a Phase 2 interventional studying Depression, sponsored by Stanford University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About 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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Depression and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 162 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Depression subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated willing to sign a consent form form 2. Stated willingness to comply with all study procedures and lifestyle considerations (see Section 5.3) and availability for the duration of the study 3. Male or female 4. Age 18-60 years 5. Fluent and literate in English 6. 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 7. 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") 8. 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. Who Should NOT Join This Trial: An individual who meets any of the following criteria will be excluded from participation in this study: 1. 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) 2. Suicidality with active plan ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and lifestyle considerations (see Section 5.3) and availability for the duration of the study 3. Male or female 4. Age 18-60 years 5. Fluent and literate in English 6. 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 7. 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") 8. 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. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. 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) 2. Suicidality with active plan 3. Severe impediment to vision, hearing, and/or hand movement 4. Current or lifetime history of medical illness or brain injury that may interfere with assessments 5. Pregnant, breastfeeding, or unwilling or unable to use adequate birth control throughout the study (females of child-bearing potential only) 6. 3.0T MRI scanner contraindications (e.g., metal in the body, claustrophobia) 7. Concurrent participation in other intervention studies 8. Current use of psychotropic medications contraindicated by guanfacine or sertraline 9. 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: * ALT \> 2× ULN * AST \> 2× ULN * Current symptoms suggestive of liver dysfunction based on clinician assessment * Thyroid-related exclusions: * TSH outside normal laboratory reference range * Current symptoms suggestive of thyroid dysfunction based on clinician assessment 10. Use of substance deemed by the study physician to be unsafe for use with guanfacine 11. Current use of a strong CYP3A4 inhibitor (e.g., ketoconazole) or inducer (e.g., carbamazepine) that, in the judgment of the study clinician, may alter guanfacine plasma concentrations and cannot be safely discontinued for the duration of the study. 12. Unwillingness to verify biotype classification via fMRI 13. Unwillingness or inability to use a computer or access a computer for assessments.

Treatments Being Tested

DRUG

Guanfacine

Guanfacine immediate release is an established and safe FDA-approved treatment that acts directly by stimulating α2A adrenoceptors.

DRUG

Sertraline

Sertraline is a well-tolerated FDA-approved antidepressant that is among the most widely prescribed medications for depression.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Stanford Psychiatry and Behavioral Sciences Department
Palo Alto, California, United States
University of Illinois at Chicago
Chicago, Illinois, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06408246), the sponsor (Stanford University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06408246 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06408246?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06408246?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06408246. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06408246. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.