NCT07022405

Stratified Pharmacological Approaches for Regulating Circuit-Level Effects

Stratified Pharmacological Approaches for Regulating Circuit-Level Effects Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will be asked to attend up to two 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 taper 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. Sign up online or contact the investigators to learn more about participating in this study.

Conditions

• Depression - Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Pramipexole Immediate Release	The intervention involves taking pramipexole immediate release (IR) for 8 weeks followed by 2 weeks of down titration and follow up.

Timeline

• Start date: 2025-08-01
• Primary completion: 2030-08-01
• Completion: 2030-08-01
• First posted: 2025-06-15
• Last updated: 2025-06-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study