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Pramipexole for Major Depressive Disorder

This research study is exploring how people with major depressive disorder (depression) respond to a medication called pramipexole immediate release. Researchers want to understand how this medication affects brain circuits involved in mood and thinking. You might be eligible if you are 18-65 years old, fluent in English, and can have a special brain scan called an fMRI. The study will measure changes in your depression symptoms and mood after 8 weeks of taking pramipexole. The goal is to find new ways to personalize depression treatment by understanding how brain circuits interact with medications.

Study design
This is an interventional study with an unclear status, planning to enroll 60 participants. It involves a single treatment arm of pramipexole immediate release.
What's involved
You would attend up to two in-person testing visits, including a 4-hour fMRI brain scan, and commit to 10 weeks of treatment and remote participation. During the 10-week period, you will have weekly remote meetings and complete online surveys.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a 2-week down taper of the medication followed by a follow-up period after the 8-week treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07022405

Stratified Pharmacological Approaches for Regulating Circuit-Level Effects

Recruiting
PHASE2Ages 18–65InterventionalTreatment
Stanford University
~60 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Pramipexole Immediate Release

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
QIDS-SR: Quick Inventory of Depressive Symptomatology Self-Report
Measured over 8 weeks
+3 more outcomes measured

Conditions

Depression - Major Depressive Disorder

Explore related trials

Unipolar Depression

Where it's being run

1 sites across 1 states
California1

Who to contact

Isabelle Wydler
[email protected]
(650)-736-4393
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • QIDS-SR: Quick Inventory of Depressive Symptomatology Self-Report8 weeks

    The QIDS-SR (Quick Inventory of Depressive Symptomatology - Self-Report) is a self-report questionnaire designed to assess the severity of depressive symptoms over the past seven days. It includes 16 items that evaluate 9 symptom domains corresponding to the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for major depressive disorder: sad mood, concentration difficulties, self-criticism or guilt, suicidal ideation, loss of interest, low energy or fatigue, sleep disturbances, changes in appetite or weight, and psychomotor agitation or retardation. Each domain is rated on a scale from 0 to 3, with total scores ranging from 0 to 27. Scores are interpreted as follows: 0-5 indicates no depression, 6-10 mild, 11-15 moderate, 16-20 severe, and 21-27 very severe depression. It is brief, taking approximately 5 to 10 minutes to complete.

  • MASQ-30: Mood Anxiety Symptom Questionnaire8 weeks

    The MASQ-30 (Mood and Anxiety Symptom Questionnaire - 30-item version) is a self-report questionnaire designed to measure symptoms of depression and anxiety. It separate symptoms that are shared between depression and anxiety from those that are more specific to each condition. The MASQ-30 includes 30 questions, divided into three main areas: Anhedonic Depression, which looks at symptoms like loss of interest or pleasure; Anxious Arousal, which focuses on physical signs of anxiety such as restlessness or a racing heart; and General Distress, which captures overall emotional discomfort common to both depression and anxiety. Each question asks how much the person has experienced a particular symptom in the past week, using a scale from 1 ("not at all") to 5 ("extremely").

  • Brain imaging8 weeks

    Non-invasive brain circuit quantification as assessed by functional magnetic resonance imaging metrics of activation and connectivity.

  • Cognitive-Emotional Behavioral Assessment8 weeks

    WebNeuro is a computerized cognitive-emotional behavioral assessment designed to objectively measure cognitive and emotional function.