Recruiting
Phase 2

Pramipexole

Sponsor:

Stanford University

Code:

NCT07022405

Conditions

Depression - Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Pramipexole Immediate Release

Study Details

Brief summary:

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.

Conditions

Depression - Major Depressive Disorder

Study ID

NCT07022405

Start date

Jan 23, 2026

Status verified date

May, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pramipexole Treatment Arm

The investigators will ask eligible participants to attend up to 2 in-person testing visits and commit to 10 weeks of treatment and remote participation.

The in-person testing visit at the beginning of the study lasts up to 4 hours. 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.

Treatment involves an 8-week course of pramipexole and followed by a 2-week down titration and follow up. 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.

Interventions

Pramipexole Immediate Release

The intervention involves taking pramipexole immediate release (IR) for 8 weeks followed by 2 weeks of down titration and follow up.

Primary outcome measure

  • QIDS-SR: Quick Inventory of Depressive Symptomatology Self-Report [ Time Frame: 8 weeks ]
  • MASQ-30: Mood Anxiety Symptom Questionnaire [ Time Frame: 8 weeks ]
  • Brain imaging [ Time Frame: 8 weeks ]
  • Cognitive-Emotional Behavioral Assessment [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Isabelle Wydler

(650)-736-4393iwydler@stanford.edu

Daniella Evangelista

danevan@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94305

Contacts

Isabelle Wydler

650-736-4393iwydler@stanford.edu

Daniella Evangelista

danevan@stanford.edu

Principal Investigator:

Leanne Williams, Ph.D.

More Information

Sponsor

Stanford University

Last update posted

May 15, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-05-15.