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Search / Trial NCT07022405

Stratified Pharmacological Approaches for Regulating Circuit-Level Effects

Launched by STANFORD UNIVERSITY · Jun 6, 2025

Trial Information

Current as of July 05, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called pramipexole affects people with Major Depressive Disorder (MDD). The goal is to better understand how different parts of the brain are involved in depression and how they respond to this medication. By looking at these brain circuits, researchers hope to personalize treatment options for individuals who may not have found relief with other medications in the past. Participants will take pramipexole for eight weeks, followed by a two-week period where the dose is gradually reduced.

To participate, you should be between 18 and 65 years old, fluent in English, and willing to give consent. You will need to have a significant level of depressive symptoms, as determined by a screening questionnaire. However, you do not need a previous diagnosis of depression to join. Throughout the study, participants will also undergo brain scans to help researchers learn more about how the medication works. It’s important to note that there are certain health conditions and medications that may prevent someone from participating, so the study team will evaluate each person carefully. If you're interested in helping advance treatment options for depression, this could be a valuable opportunity.

Gender

ALL

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
  • Not having a current primary care or psychiatric provider (seen within the past year)

About Stanford University

Stanford University is a prestigious academic institution renowned for its cutting-edge research and innovation in healthcare and medicine. As a clinical trial sponsor, Stanford leverages its extensive resources, including a collaborative network of world-class researchers and state-of-the-art facilities, to advance medical knowledge and improve patient care. The university is committed to conducting rigorous, ethical research that adheres to the highest standards of scientific integrity, fostering an environment where groundbreaking discoveries can translate into effective clinical applications. Through its clinical trials, Stanford aims to address critical health challenges and contribute to the development of novel therapies and treatment strategies.

Locations

Stanford, California, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported