Stratified Pharmacological Approaches for Regulating Circuit-Level Effects
Stratified Pharmacological Approaches for Regulating Circuit-Level Effects Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "During this visit participants will undergo a non-invasive functional magnetic resonance imaging (fMRI) brain scan, complete game-like tasks in the scanner, and answer questions regarding emotional health."
- "During this 10-week period, participants will meet remotely with a study coordinator or study clinician each week to answer questions about medication side effects and emotional health and to complete online surveys to monitor mood."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how pramipexole affects depression and whether brain activity helps explain who responds to it. It is for adults ages 18–65 with depression; a past diagnosis is not needed, but a study interview must confirm depression. Treatment lasts 8 weeks, followed by 2 weeks of slowly lowering the dose and follow-up.
This research study aims to understand how people with depression respond to the medication pramipexole and to determine whether clinical response differs depending on the function of specific circuits in the brain. The investigators hope to learn which circuits are involved in depression and how these circuits interact with pramipexole to affect mood, behavior, and cognition. Eligible participants will undergo an 8-week treatment course of pramipexole followed by a 2-week down taper and follow up. The ultimate goal is to offer people experiencing depression a medication that is alternative to ones that may not have worked in the past and to apply the knowledge the investigators gain from investigating the brain circuits involved in depression to help personalize treatment. The investigators invite anyone who has recently experienced symptoms of depression to participate. A prior diagnosis of depression is not required.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18–65 years old.
- Speak and read English well and be able to understand the study tasks.
- Agree to join the study by signing a consent form.
- Pass the required safety screening for fMRI, a scan that measures brain activity.
- Score 10 or higher on the PHQ-8, a questionnaire about depression symptoms.
- Have current or returning major depression without psychosis, as confirmed by a study interview. Psychosis means losing touch with reality.
Who can't join
- Have an active suicide plan, or a suicide risk the clinician finds unsafe for the study.
- Have an illness, brain injury, or serious trouble seeing, hearing, or moving your hands that affects study tests; be unable or unlikely to follow study steps; or have an uncleared implant or other reason a brain scan is unsafe.
- Be pregnant or breastfeeding, or be unwilling or unable to use adequate birth control throughout the study.
- Have depression that did not respond to dopamine agonists, the type of medicine that includes pramipexole.
- Have a past or current diagnosis of bipolar disorder, schizophrenia or another disorder involving loss of touch with reality, or ADHD, which affects attention and activity.
- Have current OCD (unwanted thoughts and repeated actions) or an eating disorder; an alcohol or drug use disorder in the past 12 months; or serious problems controlling urges or repeated behaviors, such as gambling, within the past 12 months.
- Take medicine for mental health now or within the past month. You may qualify after your usual clinician agrees to stopping it, you slowly stop under medical supervision, and you complete the required waiting period before the first scan.
- Be taking part in another study that tests a treatment or other intervention.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 18-65 years old (inclusive) * Fluent and literate in English, with non-impaired intellectual abilities to ensure adequate comprehension of the task instructions. * Willing to provide written, informed consent. * Functional magnetic resonance imaging (fMRI) scanning eligibility. All participants will need to successfully complete the screening forms at the Stanford Center for Cognitive and Neurobiological Imaging (CNI). * Patient Health Questionnaire-8 (PHQ-8) \>/= 10 * Meet the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for current or recurrent nonpsychotic Major Depressive Disorder (MDD) established by the Mini International Neuropsychiatric Interview (MINI) Exclusion Criteria: * Suicidality with active plan or as determined clinician judgment * Current or lifetime history of medical illness or brain injury that may interfere with assessments as determined by clinician judgment * Severe impediment to vision, hearing, and/or hand movement likely to interfere with ability to complete the assessments, or is unable and/or unlikely to follow the study protocols as determined by clinician judgment * Pregnant, breastfeeding or unwilling or unable to use adequate birth control throughout the study * History of non-responsive depression to dopamine agonists * Any contraindication to being scanned in the 3.0T fMRI scanner, such as a cardiac pacemaker or implanted device that has not been cleared for scanning * Previous or current DSM-5 bipolar disorder (I, II, not otherwise specified), schizophrenia spectrum or other psychotic disorders, or psychosis or as determined by clinician judgment * Previous or current diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD) * Meeting DSM-5 criteria for current Obsessive-Compulsive Disorder (OCD) or eating disorder * Meeting DSM-5 criteria for alcohol use disorder or substance use disorder within the last 12 months * Clinically significant presence/history of impulsive-compulsive behaviors or control disorder including but not limited to gambling disorder within the last 12 months. * Current use or use of psychotropic medication within the past month. (If the participant's usual treating clinician agrees with discontinuing the medication, participants may enroll after tapering off the medication under the supervision of either their usual clinician or the study clinician. A washout period of 5 half-lives-or a different duration as determined by the study clinician-must be completed before the first scan.) * Concurrent participation in other intervention or treatment studies
Study sites (1)
CA
- Stanford University · Palo Alto, CA 94305Isabelle Wydler · Study contact · 650-736-4393 · iwydler@stanford.eduDaniella Evangelista · Study contact · danevan@stanford.eduLeanne Williams, Ph.D. · Principal investigatorTeddy Akiki, MD · Principal investigatorMore trials in Palo Alto