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New treatment option for Depression
Official title ACE-D Aim 3 Clinical Cognitive Trial to Enhance Translation in Depression
ClinicalTrials.gov ID: NCT06408246
What this study is testing
What is Guanfacine?
Guanfacine is an investigational medicine, being studied as a potential treatment for depression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join 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
You likely can't join 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)
See the full eligibility criteria
- 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...
- 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...
- 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:
- 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
- Use of substance deemed by the study physician to be unsafe for use with guanfacine
- 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...
- Unwillingness to verify biotype classification via fMRI
- Unwillingness or inability to use a computer or access a computer for assessments.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.